Syndesi

Syndesi Therapeutics announces initiation of Phase I study of novel SV2A modulator, SDI-118, in development for the treatment of cognitive impairment

Belgium – Syndesi Therapeutics SA, a biotechnology company developing novel modulators of the synaptic vesicle protein SV2A for the treatment of cognitive impairment, today announced that its lead molecule, SDI-118, has entered into Phase I clinical development.

The first-in-human Phase I study is investigating the safety, tolerability and pharmacokinetics of single ascending doses of SDI-118 in healthy subjects. The study also includes PET imaging in a group of subjects to directly measure the binding of SDI- 118 to SV2A in the brain and to assess the relationship between SV2A occupancy and plasma exposure.

Jonathan Savidge, CEO of Syndesi, said “We are delighted to announce the entry of SDI- 118 into clinical development following successful completion of pre-clinical studies during the first year following Syndesi’s incorporation. Conducting PET imaging in parallel with the dose escalation provides us with highly valuable data very early in the development program. This ability to measure the degree of target engagement of our compound in humans greatly facilitates the choice of doses in future trials, de-risking one of the major challenges in CNS drug development.”

About Syndesi Therapeutics

Syndesi Therapeutics was established to develop a series of novel, pro-cognitive small molecule SV2A modulators licensed from UCB. In February 2018 the company announced €17M in Series A funding from a syndicate of Belgium and international investors. In March 2019, Syndesi announced the award of up to €3.2 M in non-dilutive funding from the Walloon Region to support the development of the lead molecule SDI- 118 through Phase I clinical development. Syndesi is investigating the potential of these novel SV2A modulators to improve cognition in diseases such as Alzheimer’s Disease and other dementias, as well other conditions such as cognitive impairment associated with schizophrenia. For more information please visit www.syndesitherapeutics.com

Syndesi Therapeutics awarded non-dilutive funding of up to €3.2M for development of its lead program, SDI-118, aimed at treating cognitive impairment

Syndesi Therapeutics SA, a biotechnology company developing novel SV2A modulators for cognitive impairment, today announced it has been granted up to EUR 3.2 M in non-dilutive funding from the Walloon Region. The funding is provided in the form of an ‘avance récupérable’ (recoverable loan), repayable under certain conditions with the majority of the repayment linked to the success of the programme.

Jonathan Savidge, CEO of Syndesi, said “We very much appreciate the Walloon Region’s ongoing support for the continued development of this program. This is an area of high unmet need where it has proven challenging to develop new therapeutics. This additional support will enable us to leverage our investor financing to expand the clinical development program for SDI-118 and maximize the chance of bringing this promising molecule to patients.”

The funding will support the development of SDI-118 through Phase I clinical studies, which will include PET imaging to directly measure the binding of SDI-118 to its target in the brain, providing key information for subsequent dose selection.

About Syndesi Therapeutics

Syndesi Therapeutics was established to develop a series of novel, pro-cognitive small molecule SV2A modulators licensed from UCB, and in February 2018 announced €17M in Series A funding from a syndicate of Belgium and international investors. Syndesi is investigating the potential of these novel SV2A modulators to improve cognition in diseases such as Alzheimer’s Disease and other dementias, as well as cognitive impairment associated with schizophrenia and other conditions. The discovery of the lead molecule, SDI-118, at UCB benefitted from prior support of the Walloon Region. For more information please visit www.syndesitherapeutics.com

Syndesi Therapeutics announces appointment of Roy Twyman MD to its Board of Directors

Syndesi Therapeutics SA, a biotech company developing novel treatments for cognitive impairment, today announced the appointment of Dr Roy Twyman to its Board as an independent non-executive Director.

Dr Twyman spent over 19 years at Janssen Research & Development (part of the Janssen Pharmaceutical Companies of Johnson & Johnson) in CNS development, holding roles of increasing responsibility. Most recently, Dr Twyman was Senior Vice President in the Neuroscience Therapeutic Area at Janssen. In this role, he had responsibility to oversee the Alzheimer’s Disease Area across all stages of R&D, including oversight of Neuroscience Experimental Medicine group covering clinical development from first time in human to proof of concept. Prior to joining Janssen in 1998, Dr Twyman held professorships in neurology at University of Michigan and University of Utah and gained his MD from University of Kentucky.

“I am delighted to welcome Roy onto Syndesi’s Board,” commented Jean Combalbert, Chair of the Board. “The fact that Syndesi has convinced an acknowledged world leader in CNS such as Roy to join the board reflects the promise of the pro-cognitive SV2A modulators for the treatment of Alzheimer's disease and other conditions. Roy’s contribution will definitively be a major asset for the company.”

Jonathan Savidge, CEO of Syndesi said “With his tremendous experience in CNS drug development, Roy brings complimentary expertise to the Board and his appointment is a major value add for the company as we prepare for Phase I entry with our lead molecule SDI-118, a small molecule modulator of SV2A that acts in a distinct way to the approved anti-epileptic compounds acting on this target.”

Commenting on his appointment, Dr Twyman noted “There is a need to explore new mechanisms that could help alleviate symptoms of cognitive impairment in dementia and other neuropsychiatric disorders. Modulation of SV2A, an important protein involved in synaptic communication between neurons, has been shown to be a successful therapeutic strategy in epilepsy. Syndesi are developing an intriguing lead molecule that modulates SV2A in a distinct way. By directly targeting synaptic dysfunction, Syndesi’s research and development effort represents a promising approach for the treatment of cognitive impairment in conditions such as Alzheimer’s Disease.”

About Syndesi Therapeutics

Syndesi Therapeutics was established to develop a series of novel, pro-cognitive small molecule SV2A modulators licensed from UCB. Syndesi is investigating the potential of these molecule to improve cognition in diseases such as Alzheimer’s Disease, other dementias and cognitive impairment associated with schizophrenia. The lead molecule, SDI-118 is anticipated to commence first in human Phase I studies in H1 2019. Syndesi announced a Series A financing round of €17M in February 2018, led by Novo Seeds and Fountain Healthcare with participation from Johnson & Johnson Innovation – JJDC, SRIW (Société Régionale d’Investissement de Wallonie), V-Bio Ventures and Vives Fund. Syndesi has been established at the Centre d’Entreprises et d’Innovation (CEI) in Louvain-la-Neuve, Belgium and is a resident company at Johnson & Johnson Innovation, JLABS (JLABS @ BE) in Beerse, Belgium.

For more information please visit www.syndesitherapeutics.com

Syndesi Therapeutics announces appointment of Jean Combalbert as Chairman of the Board

Belgium – Syndesi Therapeutics SA, a newly formed biotech company developing novel treatments for cognitive impairment, today announced the appointment of Dr Jean Combalbert as Independent Director and Chairman of the Board.

Dr Combalbert is a successful entrepreneur with more than 20 years of experience in pharmaceutical and biotech companies. He was CEO of Ogeda (formerly Euroscreen) from 2006 until its sale to Astellas Pharma Inc. in May 2017. Prior to joining Ogeda, he was VP Pharmaceutical Development at Proteus SA, Nimes, France, then Chairman & CEO of Entomed SA, Strasbourg, France. Earlier in his career, Dr Combalbert held senior positions with Sanofi in France and Galderma in France and the United States. Dr Combalbert received his PharmD and a PhD from the Université de Pharmacie, Marseille, France.

“I am impressed by the unique partnership between UCB and a syndicate of leading investors both here in Belgium and internationally that has created Syndesi to progress an intriguing new therapeutic approach for the treatment of dementia and other cognitive disorders. I am excited to work with the Board and management to support the Company in its mission to demonstrate the potential of novel modulators of SV2A for the treatment of cognitive impairment,” commented Jean Combalbert.

“It is a great pleasure to welcome Jean onto Syndesi’s Board,” said Jonathan Savidge, CEO of Syndesi. “The company is very fortunate to have attached a chairman with Jean’s experience and impressive track record in the biotech sector. I look forward to working with him, the Board and my management colleagues to evolve the Company and achieve our objectives in the clinical development of our pro-cognitive SV2A modulators.” 

About Syndesi Therapeutics
Syndesi Therapeutics was established in 2017 based on an exclusive, worldwide license from UCB to develop and commercialise a series of novel, pro-cognitive small molecule SV2A modulators. Syndesi was created to further develop these novel SV2A modulators and investigate their potential to improve cognition in diseases such as Alzheimer’s Disease, other dementias and cognitive impairment associated with schizophrenia. Syndesi announced a Series A financing round of €17M in February 2018, led by Novo Seeds and Fountain Healthcare with participation from Johnson & Johnson Innovation – JJDC, SRIW (Société Régionale d’Investissement de Wallonie), V-Bio Ventures and Vives Fund. Syndesi has been established at the Centre d’Entreprises et d’Innovation (CEI) in Louvain-la-Neuve, Belgium and is a resident company at Johnson & Johnson Innovation, JLABS (JLABS @ BE) in Beerse, Belgium. For more information please visit www.syndesitherapeutics.com

UCB and investor syndicate led by Novo Seeds launch Syndesi Therapeutics to develop novel therapeutics for cognitive disorders

  • Syndesi Therapeutics to leverage UCB’s expertise in neurology drug discovery to develop potential therapeutics in cognitive disorders with a first-in-class mechanism 
  • Series A financing of €17 M from a syndicate of Belgian and international investors

The creation of Syndesi Therapeutics (‘Syndesi’) was announced today as the result of a partnership between UCB and a syndicate of Belgian and international investors. The investor syndicate is led by Novo Seeds and Fountain Healthcare together with Johnson & Johnson Innovation – JJDC, Inc. (JJDC), V-BIO Ventures, the Walloon Investment Fund (SRIW) and VIVES Louvain Technology Fund. Syndesi Therapeutics has exclusively licensed a first-in-class small molecule program from UCB and the series A investment totalling €17M will fund the clinical development of the lead compound up to early proof-of-concept in humans. 
 
Syndesi Therapeutics is based in Belgium and will leverage UCB’s neurology expertise in modulating the synaptic vesicle protein SV2A. UCB’s Neuroscience researchers in Belgium have designed a unique class of novel SV2A modulators. Unlike levetiracetam and other types of SV2A modulators   discovered and developed by UCB for epilepsy, the novel compounds are devoid of anti-epileptic properties but have demonstrated robust pro-cognitive properties in preclinical models. Cognitive impairment currently being outside UCB’s strategic scope, the decision was made to have the program further developed externally to leverage its full potential. The discovery of these novel pro-cognitive SV2A modulators at UCB has benefitted from prior support of the Walloon Region, and Syndesi will use the Series A investment to build upon that work and move the lead molecule into clinical development.
 
“UCB is the world leader in SV2A research, having discovered and developed two major anti-epileptic drugs treating patients around the world. We are excited to see Syndesi develop our novel pro-cognitive SV2A modulators to create value for patients with cognitive impairment,” said Dhavalkumar Patel, UCB’s Chief Scientific Officer and Executive Vice President. “The Belgian life science ecosystem is particularly vibrant and we realised that it was the right environment to promote this research as part of our biotech model approach.”
 
Jonathan Savidge, PhD CEO of Syndesi noted “Development of these small molecules that modulate the SV2A target in a distinct manner represents an intriguing new approach for the treatment of cognitive deficits since they specifically target synaptic dysfunction, a hallmark of Alzheimer’s Disease and other indications characterized by cognitive impairment. Syndesi benefits both from UCB’s research expertise and from an impressive syndicate of experienced investors and their respective networks.”
 
“Cognitive impairment remains an area of significant unmet need for patients not only with Alzheimer’s Disease but also more broadly across a range of neurological disorders, and we are excited about the potential promise of this novel therapeutic approach,” says Morten Graugaard Døssing, Principal at Novo Seeds. “I am thrilled to be working with the company which is supported by scientists at UCB and able to leverage Janssen neuroscience expertise via a presence at the JLINX incubator, all in an effort to develop products that could one day make a meaningful difference for patients suffering from cognitive impairment.”
 
About Syndesi Therapeutics
Syndesi Therapeutics (www.syndesitherapeutics.com) has been established at the Centre d’Entreprises et d’Innovation (CEI) in Louvain-la-Neuve and will have a presence at the JLINX incubator facilities to access expertise at the Janssen campus in Beerse, Belgium. Syndesi has an exclusive, worldwide license from UCB to develop and commercialise a series of novel, pro-cognitive SV2A modulators. Syndesi will build on a rich legacy of work by UCB to further develop these novel SV2A modulators to investigate their potential to improve cognition in diseases such as Alzheimer’s Disease, other dementias and cognitive impairment associated with schizophrenia. 
 
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases in immunology and neurology. With more than 7500 people in approximately 40 countries, the company generated revenue of €4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
 
About Novo Holdings and Novo Seeds
Novo Seeds is the early-stage investment arm of Novo Holdings (www.novoholdings.dk). Novo Holdings is a private limited liability company wholly owned by the Novo Nordisk Foundation. The company is the holding company in the Novo Group, comprising Novo Nordisk A/S, Novozymes A/S and NNIT A/S, and is responsible for managing the Foundation’s assets. In addition to being the major shareholder in the Novo Group companies, Novo Holdings provides seed and venture capital to development-stage companies, takes significant ownership positions in well-established companies within the life sciences and manages a broad portfolio of financial assets. 
 
About Fountain Healthcare Partners
Fountain Healthcare Partners (www.fh-partners.com) is a life science focused venture capital fund with €176 million ($200 million) under management. Within the life science sector, specific areas of interest to Fountain include specialty pharma, medical devices, biotechnology and diagnostics. The firm deploys the majority of its capital in Europe, with the balance in the United States. Fountain’s main office is in Dublin, Ireland, with a second office in New York. 
 
About Johnson & Johnson Innovation – JJDC, Inc. (JJDC)
Johnson & Johnson Innovation – JJDC Inc. (JJDC) is the strategic venture capital arm of Johnson & Johnson and a long-term investment partner to global healthcare entrepreneurs. Founded in 1973, JJDC continues a legacy of customizing deals for data-driven companies across the continuum of healthcare, with the goal of turning great ideas into transformative new pharmaceutical, medical device and consumer healthcare products. www.jjdc.com
 
About V-Bio Ventures
V-Bio Ventures (www.v-bio.ventures) is an independent venture capital firm specialized in building and financing young, innovative life science companies. V-Bio Ventures was established in 2015 and works closely with Belgium-based VIB, one of the world’s premier life science institutes. The fund invests throughout Europe in start-up and early-stage companies with high growth potential focusing on technologies that provide transformational improvements in the biopharmaceutical, pharmaceutical, diagnostics and agricultural sectors. 
 
About SRIW SA
SRIW Société Régionale d'Investissement de Wallonie (www.sriw.be) provides equity and/or debt to companies that generate added value and employment in Wallonia.  SRIW facilitates the region's economic development, contributing effectively to the modernisation, growth and restructuring of the businesses that make up the Walloon industrial network. In the life science sector, SRIW is investor in more than 30 companies such as I.B.A., Celyad, or Ogeda of which it recently exited. Its current portfolio fair value is above 150 million €.
 
About VIVES-Louvain Technology Fund
The VIVES Louvain Technology Fund (www.vivesfund.com) is a multi-sector technology fund which invests in the spin-offs of the Université catholique de Louvain (UCL) and start-ups in Belgium and neighboring countries. VIVES II is funded by a dozen leading Belgian and European investors such as the EUROPEAN INVESTMENT FUND (EIF), SFPI-FPIM, BNP PARIBAS FORTIS PRIVATE EQUITY BELGIUM, BPI FRANCE (France), ING BELGIUM, SOFINA, AXA BELGIUM, BELFIUS, IRD (France), NIVELINVEST, REGION BRUXELLES CAPITAL and by SOPARTEC. The objective of the fund is to invest in the development of start-ups, from validation of the technology to commercial maturity. The funds (VIVES I - €15 million and VIVES II - €43 million) are managed by SOPARTEC, UCL’s technology transfer company, member of the Louvain Technology Transfer Office.
 
For further information, UCB: 
 
Corporate Communications
France Nivelle  
Global Communications, UCB
T +32.2.559.9178 france.nivelle@ucb.com
 
Laurent Schots
Media Relations, UCB  
T+32.2.559.92.64  Laurent.schots@ucb.com
 
Investor Relations
Antje Witte          
Investor Relations, UCB
T +32.2.559.94.14 antje.witte@ucb.com
 
Isabelle Ghellynck,
 Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com