Cerevance Parkinson's Drug Solengepras Shows Promise in Phase 3 Trial, Paving Way for FDA Discussions
Cerevance, a neuroscience spinout from Takeda, announced that its Parkinson’s disease therapy, solengepras, successfully met its primary endpoint in a late-stage clinical trial. The Phase 3 ARISE trial demonstrated that a high 150-mg dose of solengepras significantly reduced daily 'off time'—periods when standard Parkinson's drugs wear off and symptoms return—by 0.61 hours compared to placebo at week 12. This benefit was observed as early as the second week of treatment. Additionally, the therapy increased 'on time' without difficult symptoms like dyskinesia, which are involuntary, erratic movements associated with Parkinson’s. The study also noted improvements in daytime sleepiness and overall quality of life, suggesting broad motor and non-motor benefits. The ARISE study involved 341 Parkinson's patients experiencing motor fluctuations with standard levodopa and other medications. At baseline, patients averaged 5.65 hours of off time daily, which dropped by 1.56 hours in the 150-mg solengepras group vers...