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Civitas Therapeutics announces positive Phase II clinical results an inhaled L-dopa for Parkinson’s disease
Civitas Therapeutics, Inc., a privately-held pharmaceutical company developing transformative therapeutics using the ARCUS(TM) respiratory delivery platform, announced positive topline results from a Phase II clinical trial of CVT-301, an inhaled formulation of levodopa (L-dopa). CVT-301 is being developed as an adjunct therapy to provide rapid and reliable relief from intermittent debilitating motor fluctuations (OFF episodes) that impact a large proportion of Parkinson’s disease patients.

The study used a randomized, placebo-controlled design to evaluate L-dopa pharmacokinetics and pharmacodynamic effects following administration of CVT-301 to Parkinson’s disease patients experiencing motor fluctuations. Administering CVT-301 to patients in the OFF state produced a rapid and durable improvement in motor function. The pharmacokinetic data recapitulated the Phase I study results showing CVT-301 provided immediate L-dopa absorption and consistent increases in plasma concentrations in marked contrast to the delayed and variable L-dopa levels seen with Sinemet® (oral L-dopa/carbidopa). All doses of CVT-301 were safe and well tolerated with no increase in the frequency or severity of dyskinesias relative to oral.

“The unpredictable wearing off of oral L-dopa and the dyskinetic side effects are among the most significant challenges with the current management of Parkinson’s disease,” said Dr. Todd Sherer, CEO of The Michael J. Fox Foundation for Parkinson’s Research. “There remains a critical unmet need for therapies that increase the reliability of L-dopa while not exacerbating the side effects.”

“The significant inherent variability of oral L-dopa absorption is known to be a major contributor to the development of debilitating OFF episodes,” said Dr. Martin Freed, Chief Medical Officer and co-founder of Civitas. “CVT-301 has the potential to provide a transformative benefit to patients by enabling more predictable and effective symptomatic relief without worsening side effects such as dyskinesia, thereby allowing them to regain control of their lives.”

“The results of this study represent proof-of-concept of CVT-301 as a therapy to provide rapid and precise control of patients’ L-dopa levels enabling better management of their intermittent motor fluctuations. This has the potential to be a very meaningful advancement in the symptomatic treatment of Parkinson’s disease,” said Dr. Karl Kieburtz, President of Clintrex LLC, the Robert J. Joynt Professor of Neurology, University of Rochester, and a member of the Civitas Scientific Advisory Board.

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

The Phase II study (CVT-301-002) was a multicenter, randomized, double blind, placebo-controlled, single dose, cross-over design with three arms (placebo, 25mg and 50mg) and included an “open label” oral Sinemet arm. The 24 patients treated in this study underwent serial evaluations of L-dopa plasma levels, motor response, and safety at each visit. The patients were administered the study drug in the OFF state with the serial evaluations starting prior to dosing and continuing for up to 180 minutes post-dose. Motor function was measured using a tapping test, the Unified Parkinson’s Disease Rating Scale Part III (UPDRS III), and subjective evaluation of “meaningful” ON and OFF. Safety parameters monitored included pulmonary function, clinical laboratory data, EGCs, and vital signs (blood pressure, heart rate, and orthostatic blood pressure). This study was designed to measure the time, magnitude, and durability of CVT-301’s effect on motor function, to evaluate the safety and tolerability of CVT-301 in Parkinson’s disease patients, to confirm the results from a CVT-301 Phase I healthy volunteer study (CVT-301-001), and to establish the dose for future clinical trials with CVT-301.

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