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Cerevance Reports Positive Phase 2 Clinical Trial Results with CVN424, a Parkinson’s Disease Drug Working Through a New Mechanism

Demonstrates the Power of Cerevance’s Deep Understanding of Specific Human Brain Cell Types

Excerpt from the Press Release:

BOSTON, Mass., March 31, 2022 (GLOBE NEWSWIRE) — Cerevance, a private, clinical-stage drug discovery and development company focused on central nervous system diseases, today announced the completion of its Phase 2 clinical trial of CVN424, the company’s first-in-class, once-a-day, orally-delivered compound in development for the treatment of Parkinson’s disease. Beyond meeting safety objectives, the drug achieved a significant and meaningful, dose-dependent reduction of “OFF time,” which refers to periods of the day when Parkinson’s symptoms recur despite medication. It also had an encouraging side-effect profile.

CVN424 was evaluated in a randomized, double-blind, placebo-controlled multicenter Phase 2 study at two dose levels in Parkinson’s disease patients with motor fluctuations. Approximately 135 subjects with Parkinson’s disease, on a stable dosage of levodopa and other Parkinson’s medications but with at least two hours or more per day of average OFF time, were enrolled. Following baseline safety and efficacy assessments, subjects were randomized to receive once-daily doses of low-dose CVN424, high-dose CVN424 or matching placebo for four weeks.

At the high dose, CVN424 showed a 1.3-hour improvement in OFF time compared to placebo (p=0.042) at four weeks. This was accompanied by an increase in ON time without Troublesome Dyskinesia, without a meaningful worsening of ON Time with Troublesome Dyskinesia. Efficacy improved at four weeks versus at two weeks, and daytime sleepiness as measured by the Epworth Sleepiness Scale was reduced compared to placebo, differentiating it from most Parkinson’s disease drugs used as adjuncts to levodopa. At the lower dose, CVN424 also demonstrated a meaningful improvement in OFF time and ON time without Troublesome Dyskinesia compared to placebo. The most common adverse reactions were nausea, vomiting and headache, occurring in two subjects (4%) each at the higher dose. All other adverse reactions occurred in one subject or less.

“We are delighted to report these results which we believe demonstrate that CVN424 can provide a significant improvement for patients, with little exacerbation of dopaminergic side effects,” said Brad Margus, chief executive officer of Cerevance. “We look forward to rapidly advancing CVN424 into several larger clinical studies aimed at obtaining regulatory approval.”

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