In a Phase 2 study of Civitas Therapeutics’ CVT-301 inhaled levodopa (L-dopa), Parkinson’s disease patients with motor fluctuations (OFF episodes) who used the drug experienced “rapid and durable” motor function improvement, the company announced. The 24-patient randomized, placebo-controlled study was funded in part by a grant from the Michael J. Fox Foundation.
According to the company, pharmacokinetic data from the study also “recapitulated the Phase 1 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)” and all dose levels were well tolerated.
Civitas co-founder and Chief Medical Officer Martin Freed explained, “The significant inherent variability of oral L-dopa absorption is known to be a major contributor to the development of debilitating OFF episodes. 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.”
CVT-301 is a carrier-free dry powder engineered using Civitas’ ARCUS technology and delivered by the ARCUS breath-activated DPI. The platform, originally known as AIR, was developed by Alkermes and spun out to Civitas in 2010.
Read the Civitas press release.
