Civitas Therapeutics to Present Positive Clinical Study Results for CVT-301 at Sixth Annual Parkinson’s Disease Therapeutics Conference, Sponsored by The Michael J. Fox Foundation for Parkinson’s Research
Company’s first public presentation will feature results from Phase I study demonstrating pharmacokinetic clinical proof-of-concept
Company continues progress with ongoing Phase 2 clinical study
Chelsea, MA – October 15, 2012 – Civitas Therapeutics, Inc., a privately-held pharmaceutical company developing transformative therapeutics using the ARCUS(TM) respiratory delivery platform, announced today that the Company will make its first public presentation at the Sixth Annual Parkinson’s Disease Therapeutics Conference, sponsored by The Michael J. Fox Foundation for Parkinson’s Research, to be held on October 24th in New York City. Martin Freed, MD, Chief Medical Officer and co-founder of Civitas, will present the CVT-301 Phase 1 study results. CVT-301 is an inhaled levodopa (L-dopa) formulation, being developed to provide rapid alleviation of intermittent motor fluctuations (“off” episodes) associated with Parkinson’s disease.
“While L-dopa remains the most effective and widely used symptomatic agent for Parkinson’s disease, the significant intrinsic variability of the conventional oral administration of L-dopa contributes to unpredictable ‘off’ episodes that have a devastating impact on patients’ lives,” said Dr. Freed. “By enabling patients to rapidly and consistently increase their L-dopa plasma levels as they sense ‘off’ symptoms, CVT-301 has the potential to dramatically improve their ability to reliably manage their symptoms and regain control of their daily lives.”
The Phase 1 study in healthy volunteers evaluated the safety, tolerability and L-dopa pharmacokinetic profile across a range of doses of CVT-301 delivered using Civitas’ proprietary, simple handheld breath- actuated inhaler. The study showed that inhaled delivery of CVT-301 achieved therapeutic L-dopa plasma levels within five minutes of administration with unprecedented precision. Consistent and dose proportional pharmacokinetics were seen across all doses tested. In addition, all doses tested of CVT-301 were observed to be safe and well tolerated. In the context of extensive clinical experience correlating L-dopa plasma levels to symptomatic relief, the CVT-301 Phase 1 clinical study results represent pharmacokinetic clinical proof of concept.
CVT-301 is being developed as an adjunct to standard oral L-dopa therapy to enable patients to manage motor fluctuations caused in part by the inter-dose variability of oral L-dopa. Civitas anticipates reporting topline results from the ongoing CVT-301 Phase 2a double blind placebo controlled study in Parkinson’s disease patients in early 2013. Both the Phase 1 and Phase 2a study were funded in part by a grant from The Michael J. Fox Foundation for Parkinson’s Research.
CVT-301 is an inhaled levodopa (L-dopa) formulation, being developed as a therapy to provide rapid alleviation of intermittent motor fluctuations (“off” episodes) associated with Parkinson’s disease. Conventional oral L-dopa is administered at regularly scheduled intervals to provide symptomatic relief by maintaining dopamine levels in the CNS above the therapeutic threshold. However, for many patients the efficacy of oral L-dopa is significantly compromised by delayed absorption and excessive variability in the circulating plasma drug concentrations inherent to the oral delivery route. CVT-301 is an inhaled L-dopa formulation that utilizes the ARCUS(TM) platform to deliver a precise dose to the deep lung for rapid and predictable L-dopa absorption. The ARCUS platform is uniquely able to deliver the necessary L-dopa dose with the required precision with a simple breath- actuated device. In preclinical models, CVT-301 has demonstrated rapid, durable symptomatic relief, even when compared to larger doses of oral L-dopa.
The Phase 1 clinical study of CVT-301 was completed in 2011 and demonstrated pharmacokinetic proof-of-concept. Therapeutic plasma levels of L-dopa were achieved within five minutes of inhalation dosing with unprecedented precision. Dose proportional pharmacokinetics were seen across all doses tested. In addition, all doses tested of CVT-301 were safe and well tolerated. A Phase 2a study of CVT-301 is currently underway.
About Parkinson’s Disease
Over one million people in the US suffer from Parkinson’s disease, a neurodegenerative disorder caused by the diminished production of dopamine, a key neurotransmitter, resulting in progressive impairment of motor function including tremors, rigidity and difficulty in moving. Even when treated with the current standard of care, the majority of Parkinson’s patients continue to experience motor fluctuations. These motor fluctuations reduce patients’ ability to lead productive, independent lives and are recognized by patients, care givers and healthcare professionals as one of the most troubling and debilitating issues associated with the disease.
About Civitas Therapeutics
Civitas is a privately-held pharmaceutical company focused on developing a robust pipeline of inhaled therapeutics with the clinically proven ARCUS(TM) dry powder pulmonary delivery platform. The company’s lead program for Parkinson’s disease is intended to treat intermittent and debilitating motor fluctuations resulting from an inadequate response to their standard oral medications. Additional programs encompass respiratory disease, central nervous system disorders and infectious disease. Civitas exclusively licensed and purchased the technology and assets underlying the ARCUS platform from Alkermes plc, including a large intellectual property estate, a set of development stage pipeline assets, specialized equipment for respiratory products and the commercial scale GMP manufacturing facility. Civitas was launched at the beginning of 2011 with Canaan Partners, Fountain Healthcare Partners, Longitude Capital and Alkermes as investors.