In the News
Lynkuet™ (elinzanetant) approved in the EU for the treatment of moderate to severe vasomotor symptoms associated with menopause or endocrine therapy for breast cancer
Elinzanetant, now approved in the EU under the brand name Lynkuet™ is a dual neurokinin (NK)-targeted therapy (NK-1 and NK-3 receptor antagonist) and the only hormone-free treatment for moderate to severe vasomotor symptoms (VMS; also known as hot flashes) associated with menopause or caused by adjuvant endocrine therapy (AET) related to breast cancer / European approval in these two indications is based on positive results from the OASIS Phase III program, comprising four clinical studies (OASIS-1-4), in which elinzanetant significantly reduced the frequency and severity of moderate to severe VMS in women experiencing menopause or receiving endocrine therapy for breast cancer and demonstrated a favorable safety profile.
The European Commission has granted marketing authorization in the European Union (EU) for elinzanetant, under the brand name Lynkuet™. The compound is approved for the treatment of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) associated with menopause or caused by adjuvant endocrine therapy (AET) related to breast cancer.
“The European approval of Lynkuet™ brings a new option to women whose daily lives are disrupted by vasomotor symptoms,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceutical Leadership Team at Bayer. “We understand how challenging and isolating these symptoms can be, often interfering with daily rhythm, personal productivity, and overall quality of life. Our commitment is to support women with solutions that truly address their needs, helping them feel like them themselves again by supporting health and wellbeing at every stage.”
By 2030, it is estimated that 1.2 billion women globally will be experiencing menopause.1 VMS affect up to 80% of women during the menopausal transition.2 In Europe, approximately 40% of women report moderate to severe VMS,3 highlighting the substantial burden of these symptoms on daily life and overall well-being.
“Menopause symptoms, including hot flashes, can greatly affect women's quality of life,” said Nick Panay, Principal Investigator for OASIS-3, Consultant Gynecologist, Imperial College Healthcare NHS Trust, Professor of Practice, Imperial College London and Immediate Past President of the International Menopause Society. “This approval is an important milestone in the area of menopause care as it expands therapeutic options for women experiencing distressing menopause symptoms with a novel targeted hormone-free treatment and facilitates healthcare professionals to achieve more personalized treatment.”
VMS may also be caused by endocrine therapy, for the treatment or prevention of breast cancer. Breast cancer remains the most common cancer diagnosed in women worldwide, with approximately 70% of cases categorized as hormone-receptor positive (HR+).4,5 Endocrine therapy, an established treatment for women with HR+ breast cancer, can often result in VMS6,7 impacting quality of life and treatment adherence.
“Menopausal symptoms are common side effects of endocrine therapy for breast cancer, frequently leading to treatment discontinuation, which highlights the importance of managing these symptoms in breast cancer care,” said Dr. Fatima Cardoso, Principal Investigator of OASIS-4, from Lisbon, Portugal. “With the approval of this hormone-free therapy, we now have the first approved treatment option for this indication that will help in addressing an important unmet medical need of women and improve their quality of life during this challenging time.”
The approval of elinzanetant in the EU is based on the positive results from the OASIS Phase III clinical development program, comprising OASIS-1, -2, -3 and -4, which met all primary endpoints and key secondary endpoints in all four studies and demonstrated a favorable safety profile. Data have been published in diverse medical journals: OASIS-1 and –2 in August 2024 in The Journal of the American Medical Association (JAMA)8, OASIS-3 in The Journal of the American Medical Association (JAMA) Internal Medicine in September 20259 and OASIS-4 in the New England Journal of Medicine (NEJM) in June 2025.10
About elinzanetant (Lynkuet™)
Elinzanetant is the first dual neurokinin (NK)-targeted therapy, (NK-1 and NK- 3 receptor antagonist), globally developed for the treatment of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) associated with menopause or endocrine therapy (ET) for breast cancer, administered orally once daily. Increasing evidence indicates that hypothalamic neurons called kisspeptin, neurokinin B, and dynorphin (KNDy) neurons, expressing both NK-1 and NK-3 receptors and their ligands Substance P and NKB, play a role in thermoregulation. Declining estrogenic activity due to natural menopause or endocrine therapy leads to hyperactivity of KNDy neurons and dysregulation of the thermoregulatory center, resulting in VMS. NK-1 receptors may also have a role in the cooling response through sweating and peripheral vasodilatation as well as on sleep disturbances.
Elinzanetant is approved under the brand name Lynkuet™ in Australia, Canada, the UK, the U.S., and Switzerland for the treatment of VMS associated with menopause and in the EU for the treatment of moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy (AET) related to breast cancer. Submissions for marketing authorizations for elinzanetant are also ongoing in other markets around the world.
About the Elinzanetant clinical development program
The Phase III clinical development program of elinzanetant, OASIS, comprises four Phase III studies: OASIS-1, -2, -3 and -4. OASIS-1 and -2 investigated the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks and randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. OASIS-3 investigated the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause over 52 weeks and randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries. OASIS-4 is a double-blind, randomized, placebo-controlled multicenter study to investigate the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with endocrine therapy for treatment or prevention of hormone receptor positive (HR+) breast cancer over 52 weeks and optionally for an additional 2 years in women taking endocrine therapy, for treatment of breast cancer. 474 patients at 90 centers in 16 countries (excluding the US) were randomized.
About Menopause
By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a phase in women’s lives, related to the progressive decline of ovarian function usually occurring in their late 40s or early 50s. Menopause symptoms can also be a consequence of surgical or medical treatment such as breast cancer treatment. The most frequently reported and disruptive menopause symptoms are VMS and sleep disturbances, which can substantially affect a woman’s health, quality of life and work productivity. Addressing disruptive menopause symptoms is key to maintaining functional ability and quality of life which is highly relevant from both a healthcare and socio-economic perspective.
About Women’s Healthcare at Bayer
Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.
Bayer’s Lynkuet® (elinzanetant), the First and Only Neurokinin 1 and Neurokinin 3 Receptor Antagonist, Receives FDA Approval for Moderate to Severe Hot Flashes Due to Menopause
This approval is supported by data from the Phase III OASIS clinical trial program evaluating Lynkuet for the treatment of moderate to severe hot flashes due to menopause1
In OASIS 1 and OASIS 2, Lynkuet met the co-primary endpoints of reduction in number and severity of moderate to severe hot flashes day and night at weeks 4 and 12 from baseline1
Hot flashes are a common symptom of menopause2 and one of the main reasons women seek treatment;3 hot flashes may impact women differently4 and some can be disruptive5
Bayer announced today the U.S. Food and Drug Administration (FDA) has approved Lynkuet® (elinzanetant) 60mg capsules, the first and only dual neurokinin (NK) targeted therapy,1 neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist, for the treatment of moderate to severe hot flashes due to menopause.1 Inhibition of Substance P and Neurokinin B through antagonism of NK1 and NK3 receptor signaling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons can modulate neuronal activity in the thermoregulation associated with hot flashes.1 Lynkuet soft gel capsules are taken once daily at bedtime, with or without food.1 The FDA approval is supported by data from three Phase III clinical trials (OASIS 1, OASIS 2 and OASIS 3) that evaluated the safety and efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause.1
"The FDA approval of Lynkuet is an important new option for women and providers who are treating moderate to severe hot flashes due to menopause," said Yesmean Wahdan, M.D., Head of Medical Affairs USA & North America at Bayer. "As a global leader in women’s healthcare with more than 100 years of research and experience, we are proud to bring this new treatment option to market for women who are going through menopause and seeking hot flash relief."
The efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause was demonstrated in the first 12 weeks of two randomized, double-blind, placebo-controlled, multicenter clinical trials, OASIS 1 and OASIS 2, in 796 menopausal women.1 The co-primary efficacy endpoints in both trials were the mean change in frequency and severity of moderate to severe hot flashes from baseline to weeks 4 and 12, including day and night hot flashes.1 The safety of Lynkuet was evaluated in three randomized, double-blind, placebo-controlled, multicenter clinical trials (OASIS 1, OASIS 2 and OASIS 3) in 1,420 women.1 In OASIS 3, 627 women received Lynkuet or placebo for up to 52 weeks to evaluate long-term safety.1
It’s important to know that women who are pregnant should not take Lynkuet. Lynkuet can cause serious side effects, including central nervous system effects and daytime impairment, increased liver blood test values, risk of pregnancy loss, and risk of seizures in people with a history of seizures. The common side effects of Lynkuet include headache, fatigue, dizziness, feeling drowsy or sleepy, stomach (abdominal) pain, rash, diarrhea, and muscle spasms.1 For more information, please see “Important Safety Information” below.
“These studies investigated the safety and efficacy of elinzanetant for the treatment of moderate to severe hot flashes due to menopause,” said JoAnn Pinkerton, M.D., Professor and Director of Midlife Health at UVA Health and Lead Investigator on the OASIS 2 trial. “Hot flashes, particularly when severe, can have an impact on women’s daily lives and this approval provides healthcare providers with a new treatment option that can be used first-line for moderate to severe hot flashes due to menopause.”
“It’s important that women know they have choices for treating moderate to severe hot flashes due to menopause, and today’s approval further expands a woman’s options for treating these symptoms,” said Claire Gill, President and Founder of the National Menopause Foundation.
As a leader in women’s healthcare, Bayer is committed to making Lynkuet accessible. Through the Lynkuet Access Savings & Support program (LASS), women can connect with a healthcare provider and receive their Lynkuet prescription from home and at the lowest cost available to them. Visit Lynkuet.com to learn more about how to save on Lynkuet. If a patient cannot afford their prescription, Bayer may be able to help. Eligible patients may receive their Bayer prescription medicine at no cost through the Bayer U.S. Patient Assistance Foundation. For more information, please visit www.patientassistance.bayer.us or call to speak with a member of Bayer’s team at 1-866-2BUSPAF (228-7723).
Lynkuet is expected to be available in the U.S. beginning in November 2025. Elinzanetant is approved under the brand name LynkuetTM in Australia, Canada, the United Kingdom and Switzerland. It is pending approval in the European Union and under review in other markets around the world.
INDICATION
What is LYNKUET® (elinzanetant)?
LYNKUET is a prescription medicine used to reduce moderate to severe hot flashes (also known as vasomotor symptoms) due to menopause. LYNKUET is not a hormone. Hot flashes are feelings of warmth in the face, neck, and chest, or sudden intense feelings of heat and sweating.
IMPORTANT SAFETY INFORMATION
Do not take LYNKUET if you are:
pregnant
Before you use LYNKUET, tell your healthcare provider about all of your medical conditions, including if you:
have liver problems
have a history of seizures
are pregnant or planning to become pregnant. LYNKUET may harm your unborn baby. Women who can become pregnant should talk to their healthcare provider to exclude pregnancy before starting treatment with LYNKUET and use effective birth control during and for 2 weeks after stopping treatment.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LYNKUET may affect the way other medicines work, and other medicines may affect how LYNKUET works.
What should I avoid while taking LYNKUET?
Avoid eating grapefruit or drinking grapefruit juice during treatment with LYNKUET.
LYNKUET may cause you to feel drowsy, if you experience this avoid driving and other hazardous activities until these effects go away.
LYNKUET can cause serious side effects, including:
Central nervous system (CNS) effects and daytime impairment. LYNKUET can cause difficulty staying awake (somnolence) and other nervous system effects including fatigue, having a spinning feeling (vertigo), dizziness, and feeling faint (presyncope). If you experience these effects, you should not drive or do hazardous activities until these effects go away.
Increased liver blood test values. LYNKUET may cause increased liver enzymes. Your healthcare provider will do a blood test to check your liver before you start and 3 months after taking LYNKUET. Stop taking LYNKUET and tell your healthcare provider right away if you have the following signs or symptoms that suggest liver problems:
feeling more tired than you do usually
decreased appetite
nausea
vomiting
itching
yellowing of the eyes or skin (jaundice)
pale feces
dark urine
pain in the stomach (abdomen)
Risk of pregnancy loss. Taking LYNKUET while pregnant may cause loss of pregnancy or stillbirth. If you think you are pregnant, stop taking LYNKUET and tell your healthcare provider right away.
Risk of seizures in people with a history of seizures. Seek medical attention right away if you have loss of consciousness or seizure.
Common side effects of LYNKUET include:
headache
fatigue
dizziness
feeling drowsy or sleepy
stomach (abdominal) pain
rash
diarrhea
muscle spasms
Tell your healthcare provider if you have any side effects that do not go away. These are not all the possible side effects of LYNKUET.
LYNKUET is available by prescription only.
You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088. For Bayer products, you can report these directly to Bayer by clicking here.
For important information about LYNKUET, please see the accompanying Full Prescribing Information.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.
Find more information at www.pharma.bayer.com
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Disclosures
Claire Gill of The National Menopause Foundation is a long-standing advocacy partner of Bayer and has received financial compensation for her contributions.
References
1 LYNKUET® (elinzanetant) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; October 2025
2 Thurston RC, Joffe H. Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am. 2011;38(3):489-501.
3 Kronenberg F. Menopausal hot flashes: a review of physiology and biosociocultural perspective on methods of assessment. J Nutr. 2010;140(7):1380S-5S.
4 Shepherd JA, Shiozawa A, Schild AL, et. al. Retrospective text and qualitative analyses of patient experience and management of vasomotor symptoms due to menopause: voices from the PatientsLikeMe community. Menopause. 2024;31(9):789-795.
5 US Food and Drug Administration. Estrogen and estrogen/progestin drug products to treat vasomotor symptoms and vulvar and vaginal atrophy. FDA. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/estrogen-and-estrogenprogestin-drug-products-treat-vasomotor-symptoms-and-vulvar-and-vaginal-atrophy. Accessed October 23, 2025.
Bayer to acquire UK-based biotech KaNDy Therapeutics Ltd.
Further expansion of Bayer’s drug development pipeline in Women’s Healthcare
Upfront consideration of USD 425 million and additional potential consideration in the form of milestone payments
Bayer, a global leader in women’s healthcare, and KaNDy Therapeutics Ltd, a UK clinical-stage biotech company, today announce that Bayer will acquire KaNDy Therapeutics Ltd. to expand its drug development pipeline in women’s healthcare.
Under the terms of the agreement Bayer will pay an upfront consideration of USD 425 million, potential milestone payments of up to USD 450 million until launch followed by potential additional triple digit million sales milestone payments. Closing is subject to customary conditions, in particular anti-trust approval, and is expected by September 2020.
The acquisition of KaNDy Therapeutics Ltd. is another important milestone in augmenting Bayer’s own women’s healthcare portfolio through strategic collaborations and agreements.
Morgan Stanley is serving as financial advisor to Bayer, while Linklaters is serving as legal counsel. Goldman Sachs International is serving as financial advisor to KaNDy Therapeutics Ltd., while Goodwin is serving as legal counsel.
Bayer Contact:
Phone +44 (0)118 206-3977
Email: communications.ukireland@bayer.com
KaNDy Therapeutics Ltd. Contact:
Phone +44 (0)7885 715 857
Email: kandyTherapeutics@consilium-comms.com
KaNDy Therapeutics Announces Positive Phase 2b Data in Post-Menopausal Women with its Lead Non-Hormonal Product NT-814
Phase 2b dose range finding study showed rapid and highly significant reductions in the frequency of hot flashes (primary endpoint) for the full 12-week treatment period
Reduction in hot flashes was associated with statistically significant improvements in quality of life, mood and sleep – all key secondary endpoints
All doses of NT-814 were well tolerated during the study, demonstrating a safety profile that supports progression to Phase 3 ~
Stevenage, UK – KaNDy Therapeutics, a UK clinical-stage biotech company, today announces positive data from the Phase 2b “SWITCH-1” clinical trial with its lead non-hormonal drug candidate, NT-814, for the treatment of symptoms of the menopause.
Following on from the clear benefits NT-814 demonstrated in the Phase 2a RELENT-1 study, the SWITCH-1 trial provides further compelling evidence that NT-814, a first in class, once-daily, oral neurokinin-1,3 receptor antagonist, can produce a rapid and marked reduction in the most troublesome and frequent symptoms of the menopause, hot flashes and night sweats (vasomotor symptoms). The clinical relevance of the marked improvements shown on the vasomotor symptom endpoints was supported by highly statistically significant improvements across patient reported assessments of quality of life, mood and sleep.
The SWITCH-1 study was a randomised, double-blind, placebo-controlled trial conducted in the US, UK and Canada. One hundred and ninety-nine women experiencing at least 7 moderate or severe hot flashes/flushes (HF) per day were recruited into the study and randomised to receive one of four doses of NT-814 or placebo. Treatment with NT-814 once daily for 12 weeks at the most effective dose evaluated resulted in:
Statistically significant reductions compared to placebo in average hot flash frequency (primary endpoint), starting during the first week of treatment and continuing throughout the 12-week treatment period. Least squares mean reductions in average hot flash frequency were -6.7 for NT-814 vs -2.7 for placebo at week 4, and -7.8 vs -4.7 at Week 12 (p<0.0001 and p=0.0092, respectively).
Marked improvements in all key secondary endpoints: improved quality of life was shown by highly significant improvements over placebo in the MenQoL menopause-specific quality of life scores, benefits on mood were demonstrated by significant improvements in the Beck Depression Inventory (II), and improved quality of sleep was shown by statistically significant improvements compared to placebo in the Pittsburgh Sleep Quality Index scores.
NT-814 was well tolerated across the dose range with a safety profile that supports progression to Phase 3.
Dr. James A. Simon, Clinical Professor of Reproductive Endocrinology & Infertility at George Washington University, and the study’s Lead Investigator, commented: “These top-line results of the SWITCH-1 study are very exciting. They demonstrate that NT-814, a truly novel therapy, offers a rapidly effective, non-hormonal approach to treating menopausal hot flashes and night sweats, debilitating symptoms of menopause. Unique to this trial, patients also reported improvements in quality of life, mood and sleep with NT-814.”
Dr Mary Kerr, Co-Founder and CEO KaNDy Therapeutics, said: “The SWITCH-1 study started in November 2018, and so we are excited to share such positive results on schedule. The data confirms and validates Phase 2a observations, providing more evidence that neurokinins are fundamental to sex hormone biology and the pathophysiology of the menopause, resulting in almost immediate symptom relief. The Company looks forward to presenting these data at future scientific meetings and discussing it with regulatory agencies in advance of progressing the compound into pivotal registration studies.”
For more information, please contact:
KaNDy Therapeutics
Email: info@kandytherapeutics.com
Consilium Strategic Communications
Mary-Jane Elliott/ Lindsey Neville/ Carina Jurs
Tel: +44 (0) 20 3709 5700
KaNDyTherapeutics@consilium-comms.com
About the SWITCH-1 Study:
The Phase 2b SWITCH-1 study was a randomised, double-blind, placebo-controlled study conducted at 25 sites in the UK, US and Canada. It included an adaptive randomisation design that enabled the randomisation ratio to be modified to focus on doses of greatest interest based on emerging data. The study was initiated in November 2018 and completed, ahead of schedule, at the end of 2019. A total of 199 post-menopausal women experiencing at least 7 moderate or severe HFs per week were recruited into the study and randomized to receive one of four doses of NT-814 or placebo. Study drug was taken once daily in the evening for 12 weeks. Subjects completed electronic diaries twice daily for the two weeks before and throughout treatment and underwent routine safety assessments periodically throughout the trial. Patient reported assessments of sleep, quality of life and mood were also completed periodically during study visits. Further information on the study design can be found on www.clinicaltrials.gov and full results of the study will be published at scientific congresses and in peer-reviewed journals over the coming months.
NT-814 is an orally administered, potent and selective small molecule dual antagonist of both the neurokinin-1 and 3 receptors under development by KaNDy as a therapy for a range of Women’s Health conditions. NT-814 addresses vasomotor symptoms by modulating a group of oestrogen sensitive neurones in the hypothalamus in the brain (the KNDy neurones), that in menopausal women due to the absence of oestrogen, become hyperactive and consequently disrupt body heat control mechanisms resulting in the debilitating vasomotor symptoms of hot flashes and night sweats.
KaNDy Therapeutics is a clinical-stage company focused on optimizing the potential of NT-814 in the treatment of common, chronic debilitating female sex-hormone related conditions. These conditions, such as post-menopausal vasomotor symptoms, are debilitating for women often over many years and associated with significant healthcare and economic costs. NT-814 is wholly owned by KaNDy.
KaNDy Therapeutics announces initiation of Phase 2b trial of NT-814 for the treatment of troublesome post-menopausal symptoms
Stevenage, UK - KaNDy Therapeutics, a clinical-stage company developing a potential breakthrough non-hormonal treatment for multiple debilitating symptoms of the menopause, today announces initiation of the Phase 2b clinical trial evaluating NT-814 in women with troublesome symptoms of the menopause. The study (called SWITCH-1) will evaluate the effect of treatment with NT-814 on hot flashes and other symptoms of the menopause.
Dr. Steve Pawsey, Chief Medical Officer of KaNDy Therapeutics, said: “We are very pleased to have initiated the Phase 2b, SWITCH-1 study, on schedule with our previous guidance. We anticipate that results from this trial will validate the Phase 2a results and position NT-814 as a novel, non-hormonal treatment for women suffering from troublesome symptoms of the menopause. We will continue to enrol patients over the coming months and look forward to reporting results in late 2019. We expect NT-814 to be fully Phase 3 ready in H2 2020”
Prof. James A. Simon, Coordinating Principal Investigator on the SWITCH-1 Study and Scientific and Clinical Advisor to KaNDy Therapeutics said: “There are millions of women worldwide suffering from debilitating symptoms of the menopause and a non-hormonal treatment that could offer relief would be extremely valuable to this population. NT-814 has delivered very encouraging results to date and I am hopeful that findings from this trial will be equally promising.”
SWITCH-1 is a Phase 2b, double-blind, randomised, placebo-controlled, adaptive study designed to determine the effectiveness and safety of NT-814, taken once daily, for the treatment of troublesome post-menopausal symptoms. Four doses of NT-814 (40 mg once a day, 80 mg once a day, 120 mg once a day and 160 mg once a day) will be investigated and compared to placebo, in five parallel groups. The study is anticipated to enrol approximately 165 postmenopausal women aged 40 to 65 years although the exact number will be determined during the adaptive design reviews. Subjects will participate in the study for a total of approximately 19 weeks, comprising a screening period of three weeks, a 12-week treatment period and then a final follow up visit four weeks after the end of the treatment period. The co-primary efficacy endpoints will be the change from baseline in frequency and severity of moderate and severe hot flashes at Weeks 4 and 12 of treatment.
More information can be found at www.clinicaltrials.gov, identifier: NCT03596762
For more information, please contact:
KaNDy Therapeutics
Mary Kerr, Chief Executive Officer
Tel: +44 1438 906960
Email: info@kandytherapeutics.com
Consilium Strategic Communications
Mary-Jane Elliott/ Lindsey Neville/ Carina Jurs
Tel: +44 (0) 20 3709 5700
KaNDyTherapeutics@consilium-comms.com
KaNDy Therapeutics is a clinical-stage company developing a potential breakthrough non-hormonal treatment for multiple debilitating symptoms of the menopause including hot flashes and sleep disturbance due to night sweats. KaNDy’s drug in development, NT-814 is a unique dual mechanism NK(neurokinin)-1,3 receptor antagonist with the potential to ‘switch off’ multiple debilitating symptoms of the menopause without the need for oestrogen exposure.
Data from a Phase 1b/2a study in post-menopausal women with troublesome hot flashes showed NT-814 was able to rapidly and profoundly reduce both the frequency and severity of hot flashes as well as sleep disturbances due to night sweats. NT-814, is now being evaluated in a Phase 2b clinical trial in postmenopausal women with moderate to severe vasomotor symptoms. Headline results are expected at the end of 2019 and NT-814 will be fully Phase 3 ready by H2 2020.
For more information please visit https://www.kandytherapeutics.com/
KaNDy Therapeutics presents new compelling data with lead candidate NT-814 at The North American Menopause Society 2018 Annual Meeting
~ Treatment with NT-814 resulted in immediate improvements in bothersome post-menopausal symptoms~
~ Phase Ib/IIa data showed rapid and significant reductions in the frequency and severity of hot flashes and the number of night time awakenings~
STEVENAGE, England -- KaNDy Therapeutics, a UK clinical-stage biotech company, announces the presentation of new clinical data from the Phase Ib/IIa proof of concept clinical trial with its lead non-hormonal drug candidate, NT-814, at The North American Menopause Society 2018 Annual Meeting taking place from 3-6 October 2018 in San Diego, US.
Data from the Phase Ib/IIa RELENT-1 study, presented by Dr Steve Pawsey, Chief Medical Officer at KaNDy Therapeutics, demonstrate compelling evidence that NT-814, a novel, once-daily, oral neurokinin-1,3 receptor antagonist, being developed to provide a safe and effective alternative to hormone replacement therapy (HRT), produces a rapid and profound reduction in debilitating symptoms of the menopause including vasomotor symptoms (VMS), also known as hot flush or flash (HF), and night time awakenings.
The effects of treatment with NT-814 were immediate in onset, being both statistically significant and clinically relevant as soon as the first day of treatment. In contrast, studies with HRT have shown onset is within weeks or months.
The Phase Ib/IIa data also demonstrated that treatment with NT-814, taken once daily for two weeks at the most effective dose evaluated, resulted in rapid and significant reductions in:
the frequency of HF, with a reduction of 62% from baseline in the number of moderate and severe HF vs 24% for placebo in Week 1 (p<0.0014) and an 84% reduction from baseline vs 37% for placebo in week 2 (p<0.0002)
the severity of HF, with a reduction of 23% from baseline in average HF severity vs 9% for placebo in week 1 (p<0.015) and a 50% reduction from baseline vs 16% for placebo in Week 2 (p<0.0004)
the number of night time awakenings, with a reduction of 58% from baseline vs 17% for placebo in Week 1 (p< 0.0022) and an 81% reduction from baseline vs 32% for placebo in Week 2 (p< 0.0005).
NT-814 was found to be well-tolerated and no safety concerns were identified in the study.
Commenting on the data, Dr Steve Pawsey, Chief Medical Officer at KaNDy Therapeutics said: “These data presented today provide very compelling evidence to support the use of NT-814 to treat bothersome symptoms of the menopause. The fact that the effects of treatment are seen from the first day is extremely promising and positions NT-814 as a real alternative to HRT which can take weeks or months to be fully effective. We are looking forward to progressing this candidate through clinical development, in order to make this treatment commercially available as soon as possible.”
Dr Hadine Joffe, Paula A. Johnson Associate Professor of Psychiatry in the Field of Women’s Health, Harvard Medical School, Executive Director of the Connors Center for Women’s Health, Brigham and Women's Hospital, and Scientific and Clinical Advisor to KaNDy Therapeutics added: “The results generated thus far are indeed promising. HRT is effective and has a number of safety concerns and is slow in onset, so there is a real need for a safe, non-hormonal treatment option which acts quickly to relieve symptoms. This study has shown that NT-814 not only results in rapid and significant reductions in both hot flashes and night-time awakenings, but also that the effects of treatment are immediate. I believe NT-814 could be a potentially breakthrough non-hormonal option for the millions of women who suffer with debilitating symptoms related to menopause.”
Based on these results, KaNDy Therapeutics intends to advance NT-814 into a fully powered Phase IIb definitive dose-ranging study in patients suffering from debilitating symptoms of the menopause. The Phase IIb trial is expected to begin later this year.
The full abstract can be viewed on The NAMS website: https://www.menopause.org/annual-meetings/2018-meeting/meeting-abstracts
About the RELENT-1 Study: The Phase Ib/IIa RELENT-1 study was a randomised, double-blind, placebo-controlled study conducted at three clinical pharmacology units (CPU) in the US. Seventy-six women aged 41 to 64 years experiencing 7-20 moderate or severe HFs per day were recruited into the study and randomized to receive one of four escalating doses of NT-814 or placebo in four cohorts. Study drug was taken once daily in the morning for 14 days, the first seven of which were resident in the CPU. Subjects completed diaries twice daily for the two weeks before and throughout treatment and underwent routine safety assessments periodically throughout the trial. Further information on the study design can be found on www.clinicaltrials.gov and full results of the study will be published at scientific congresses and in peer-reviewed journals over the coming months.
NT-814 is an orally administered, potent and selective small molecule dual antagonist of both the neurokinin-1 and 3 receptors under development by KaNDy as a therapy for a range of Women’s Health conditions. NT-814 addresses VMS by modulating a group of oestrogen sensitive neurones in the hypothalamus in the brain (the KNDy neurones), that, because of the absence of oestrogen in menopausal women, become hyperactive and consequently disrupt body heat control mechanisms resulting in the debilitating vasomotor symptoms of HF.
KaNDy Therapeutics is a clinical-stage company focused on optimizing the potential of NT-814 in the treatment of common, chronic debilitating female sex-hormone related conditions. These conditions, such as post-menopausal VMS, are debilitating for women often over many years and associated with significant healthcare and economic costs.
Contacts
KaNDy Therapeutics
or
Consilium Strategic Communications
Mary-Jane Elliott/ Lindsey Neville/ Carina Jurs
Tel: +44 (0) 20 3709 5700
KaNDy Therapeutics announces positive clinical data with lead candidate NT-814 for the treatment of symptoms of the menopause
~ Phase Ib/IIa data showed rapid and highly significant reductions in the frequency and severity of hot flashes and the number of night time awakenings~
~ NT-814 is being developed to provide a valid alternative to hormone replacement therapy and will now move into a Phase IIb trial~
~ KaNDy Therapeutics also announces it will be attending the 16th World Congress on Menopause in Vancouver from 6-9 June~
Stevenage, UK – KaNDy Therapeutics, a UK clinical-stage biotech company, today announces positive data from the Phase Ib/IIa clinical trial with its lead non-hormonal drug candidate, NT-814, for the treatment of symptoms of the menopause.
Results from the trial provide compelling evidence that NT-814, a novel, once-daily, oral neurokinin-1,3 receptor antagonist, produces a rapid and profound reduction in debilitating symptoms of the menopause including vasomotor symptoms (VMS), also known as HF, and night time awakenings.
Based on these results, KaNDy Therapeutics intends to advance NT-814 into a fully powered Phase IIb definitive dose-ranging study in patients suffering from debilitating symptoms of the menopause. The Phase IIb trial will begin later this year.
The Phase Ib/IIa RELENT-1 study was a randomised, double-blind, placebo-controlled study conducted at three clinical pharmacology units (CPUs) in the US. Seventy-six women aged 41 to 64 years experiencing 7-20 moderate or severe hot flashes/flushes (HF) per week were recruited into the study and randomized to receive one of four escalating doses of NT-814 or placebo.
Treatment with NT-814 once daily for two weeks at the most effective dose evaluated, resulted in rapid and highly significant reductions in:
- the frequency of HF, with a reduction of 62% from baseline in the number of moderate and severe HF vs 24% for placebo in Week 1 (p<0.0014) and an 84% reduction from baseline vs 37% for placebo in week 2 (p<0.0002)
- the severity of HF, with a reduction of 23% from baseline in average HF severity vs 9% for placebo in week 1 (p<0.015) and a 50% reduction from baseline vs 16% for placebo in Week 2 (p<0.0004)
- the number of night time awakenings, with a reduction of 58% from baseline vs 17% for placebo in Week 1 (p< 0.0022) and an 81% reduction from baseline vs 32% for placebo in Week 2 (p< 0.0005).
NT-814 was well tolerated with no safety concerns across the dose range including routine safety labs, liver function tests, ECGs and vital signs.
Professor Richard Anderson, Elsie Inglis Professor of Clinical Reproductive Science, University of Edinburgh, and a scientific and clinical advisor to KaNDY Therapeutics, said: “These are very promising results which suggest that NT-814, a novel once daily treatment taken orally, may offer women with debilitating symptoms of the menopause, a real alternative to hormone replacement therapy (HRT). In contrast to HRT, which can take weeks or months to be fully effective, both hot flashes and night-time awakenings responded rapidly and with big changes with NT-814.”
In addition, KaNDy Therapeutics announces it will be attending the 16th World congress on Menopause taking place in Vancouver, Canada, from 6-9 June 2018. To arrange a meeting with Dr Mary Kerr, Managing Director of KaNDy Therapeutics at the congress, please contact info@kandytherapeutics.com
About the RELENT-1 Study: The Phase Ib/IIa RELENT-1 study was a randomised, double-blind, placebo-controlled study conducted at three clinical pharmacology units (CPU) in the US. Seventy-six women aged 41 to 64 years experiencing 7-20 moderate or severe HFs per week were recruited into the study and randomized to receive one of four escalating doses of NT-814 or placebo in four cohorts. Study drug was taken once daily in the morning for 14 days, the first seven of which were resident in the CPU. Subjects completed diaries twice daily for the two weeks before and throughout treatment and underwent routine safety assessments periodically throughout the trial. Further information on the study design can be found on www.clinicaltrials.gov and full results of the study will be published at scientific congresses and in peer-reviewed journals over the coming months.
NT-814 is an orally administered, potent and selective small molecule dual antagonist of both the neurokinin-1 and 3 receptors under development by KaNDy as a therapy for a range of Women’s Health conditions. NT-814 addresses VMS by modulating a group of oestrogen sensitive neurones in the hypothalamus in the brain (the KNDy neurones), that in menopausal women due to the absence of oestrogen, become hyperactive and consequently disrupt body heat control mechanisms resulting in the debilitating vasomotor symptoms of HF.
KaNDy Therapeutics is a clinical-stage company focused on optimizing the potential of NT-814 in the treatment of common, chronic debilitating female sex-hormone related conditions. These conditions, such as post-menopausal VMS, are debilitating for women often over many years and associated with significant healthcare and economic costs.
For more information, please contact:
KaNDy Therapeutics
Mary Kerr, Managing Director of KaNDy Therapeutics
Tel: +44 1438 906960
Email: info@kandytherapeutics.com
Consilium Strategic Communications
Mary-Jane Elliott/ Lindsey Neville/ Carina Jurs
Tel: +44 (0) 20 3709 5700
KaNDyTherapeutics@consilium-comms.com
KaNDy Therapeutics launched to advance a breakthrough treatment in Women's Health
First-in-class once daily NT-814 spun out of NeRRe Therapeutics into new company
Stevenage, UK - KaNDy Therapeutics has been launched today to maximise the value of NT-814, a potential breakthrough medicine for the treatment of chronic debilitating Women’s Health conditions and is backed by internationally recognised life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed Advisors.
NT-814 is a first-in-class, once daily, dual mechanism neurokinin-1,3 receptor antagonist. The medicine is being developed as a non-hormonal alternative to hormone replacement therapy for the treatment of postmenopausal vasomotor symptoms (PMVMS). NT-814 has been spun out of NeRRe Therapeutics Holdings Ltd into KaNDy Therapeutics Ltd a separate legal entity.
KaNDy Therapeutics will advance the development of NT-814 into Phase 2b in the lead indication PMVMS while also exploring its potential in other Women's Health conditions. All formulation, pre-clinical and clinical safety and efficacy data, and intellectual property associated with NT-814 have been transferred to the new company. KaNDy Therapeutics is led by Managing Director Mary Kerr and chaired by Iain Dukes, Venture Partner at OrbiMed Advisors. The company is based at the Stevenage Bioscience Catalyst in the UK.
NT-814 has significant potential to treat multiple debilitating Women’s Health conditions by virtue of the ability to beneficially modulate dysfunctional temperature control and reproductive hormone pathways. NT-814 has already successfully completed a Phase 2a proof of concept study demonstrating its potential to reduce the frequency and severity of PMVMS, and is now being prepared to enter an international Phase 2b study in this anchor indication.
Iain Dukes, Chairman of KaNDy Therapeutics, said, “The formation of KaNDy Therapeutics enables us to maximise the potential of NT-814 in a range of debilitating Women's Health conditions. We believe NT-814 is one of the few true innovations in Women’s Health in more than two decades and potentially represents a major breakthrough in areas of significant unmet medical need such as PMVMS. Mary has built up an excellent team who have made substantial progress with NT-814 and we're looking forward to advancing this exciting new product into a Phase 2b programme.”
Professor Richard Anderson, Clinical Adviser, University of Edinburgh, commented, “For many women, menopausal symptoms such as hot flashes are debilitating and long-lasting, and can have a major impact on quality of life. As a potential once daily alternative to HRT without the issues surrounding hormone replacement, NT-814 could bring them considerable relief.”
For further information, please contact:
Mary Kerr, Managing Director of KaNDy Therapeutics
Tel: +44 1438 906960
Email: info@kandytherapeutics.com
About KaNDy Therapeutics
KaNDy Therapeutics is a UK based clinical-stage company focused on optimizing the potential of its unique NK-1,3 receptor antagonist NT-814 in the treatment of common, chronic debilitating female sex-hormone related conditions. NT-814 is in development initially as a non-hormonal therapy to treat moderate to severe post-menopausal vasomotor symptoms (PMVMS)).
PMVMS affect up to 75% of peri-menopausal women. Symptoms last for 1–2 years after menopause in most women, but may continue for up to 10 years or longer in others. Approximately 20% of women will have debilitating symptoms. Hot flashes are the primary reason women seek medical care at menopause. Hot flashes not only disturb women at work and interrupt daily activities, but also have a detrimental effect on sleep. Post-menopausal vasomotor symptoms are experienced by millions of women globally on a daily basis.
The company is led by an experienced management team including Dr Mary Kerr (Managing Director), formerly SVP and Global Franchise lead at GSK and Dr Mike Trower (CSO/COO), formerly VP & Head of the External Drug Discovery Group in the Neurosciences CEDD at GSK and Dr Steve Pawsey (CMO) formerly at Circassia and Vernalis.
KaNDy Therapeutics was spun out of NeRRe Therapeutics in September 2017, and is backed by internationally recognised life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed Advisors. KaNDy Therapeutics is based at Stevenage Bioscience Catalyst. You can find more information about KaNDy Therapeutics at www.kandytherapeutics.com.