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Civitas Therapeutics Initiates Phase 2a Clinical Study of CVT-301, an Inhaled L-dopa for Parkinson's Disease


6/15/2012 9:13:12 AM

Chelsea, MA – June 15, 2012 – Civitas Therapeutics, Inc., a privately-held pharmaceutical company developing transformative therapeutics using the ARCUS(TM) respiratory delivery platform, announced today the initiation of a Phase 2a clinical trial in Parkinson’s disease patients evaluating CVT-301, an inhaled formulation of levodopa (L-dopa), for the rapid relief from motor fluctuations. CVT-301 provides immediate onset of a large and precise dose of L-dopa.

“Consistent with our commitment to rapidly develop important new therapies for patients, we demonstrated pharmacokinetic proof-of-concept for CVT-301 in less than 12 months from launching Civitas and are now initiating this Phase 2a study in Parkinson’s patients,” said Dr. Martin Freed, Chief Medical Officer and co-founder of Civitas. “Leveraging the ARCUS platform along with the 40 years of existing L-dopa clinical experience we hope to provide Parkinson’s patients with a new therapy enabling improved management of their motor fluctuations.”

The Phase 2a study is a randomized, placebo-controlled, single dose, cross-over design that will characterize the safety and tolerability of CVT-301 and evaluate pharmacodynamic effects and L-dopa pharmacokinetics in patients with Parkinson’s disease with motor fluctuations (“off episodes”). This Phase 2a study is designed to establish the dose for future clinical trials with CVT-301. Patients will receive oral Sinemet®, inhaled placebo and CVT-301 which will be followed by serial evaluations of L- dopa pharmacokinetics, motor response and safety at each visit. Twenty-four (24) patients will be enrolled.

This Phase 2a study of CVT-301 is funded in part by a grant from The Michael J. Fox Foundation for Parkinson’s Research.

About CVT-301

Civitas’ lead program, CVT-301, is an inhaled formulation of L-dopa for the immediate relief from debilitating motor fluctuations associated with Parkinson’s disease. For symptomatic relief, oral L-dopa is administered to maintain dopamine levels in the brain above the therapeutic threshold; yet 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 ARCUS(TM) therapeutic that incorporates L-dopa and is optimized to deliver a precise dose to the deep lung for rapid and predictable L-dopa absorption. The ARCUS(TM) platform is uniquely able to deliver the necessary L- dopa dose with the required precision. 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. 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 is complete, and pharmacokinetic proof-of-concept was demonstrated. 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.

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(TM) 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.



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