Phase 2 trial shows promising results for oral Parkinson’s treatment

Neuroscience company Cerevance announced the completion of its phase 2 clinical trial of CVN424, a once-daily oral compound developed for the treatment of Parkinson’s disease.

According to a company press release, the drug was assessed in a randomized, double-blind, placebo-controlled multicenter study, during which it achieved a significant dose-dependent reduction of “off time,” or periods during the day when Parkinson’s symptoms recur despite medication.

“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,” Brad Margus, CEO of Cerevance, said in the release. “We look forward to rapidly advancing CVN424 into several larger clinical studies aimed at obtaining regulatory approval.”

The phase 2 study enrolled 135 patients with PD, all of whom were on a stable dose of levodopa and other PD medications but had at least 2 hours or more per day of average off time. Participants were randomized to receive low-dose CVN424, high-dose CVN424 or matching placebo once a day for 4 weeks.

At 4 weeks, high-dose CVN424 showed a 1.3-hour improvement in off time compared with placebo, accompanied by an increase in on time without troublesome dyskinesia and without meaningful worsening of on time with troublesome dyskinesia. At low dose, CVN424 also showed improvement in off time and on time without troublesome dyskinesia compared with placebo.

The most common adverse effects were nausea, vomiting and headache, which occurred in two patients, each at the higher dose. All other adverse reactions occurred in one patient or less.