Civitas commences CVT-301 Phase 2a trial in Parkinson's disease

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.