Cerevance announced that its experimental drug solengepras successfully reduced daily "off" time by approximately 37 minutes in a late-stage clinical trial of 341 Parkinson's disease patients. Unlike traditional therapies that target dopamine, solengepras inhibits a protein regulating motor function to avoid involuntary movements. The drug also improved "on" time without causing troublesome dyskinesia and was generally well tolerated. Cerevance plans to discuss these results with the FDA.
Efficacy results of the trial
- ▪Cerevance reported positive findings on other surveys and scales that evaluated motor function, daily living, and sleepiness during the clinical trial of solengepras
- ▪Cerevance announced on October 7, 2026, that its experimental drug solengepras met the main goal of a late-stage clinical trial by significantly reducing daily "off" time for Parkinson's disease patients
- ▪The higher dose of solengepras reduced patients' average daily "off" time by 0.61 hours, or approximately 37 minutes, compared to the placebo group after 12 weeks of treatment
- ▪Patients in the higher-dose solengepras arm of Cerevance's late-stage trial experienced a 0.60-hour increase in daily "on" time compared to the placebo group, barely reaching statistical significance, without causing troublesome dyskinesia disrupting daily activities
Trial design and baseline
- ▪At the start of Cerevance's late-stage clinical trial of solengepras, participants reported an average of 5.65 hours of daily "off" time, when their Parkinson's medications waned and symptoms returned or worsened
- ▪Cerevance's late-stage clinical trial of solengepras randomized 341 participants who experienced motor fluctuations despite taking levodopa to receive either a placebo, a lower dose of solengepras, or a higher dose of solengepras
Safety and tolerability of solengepras
- ▪The most frequently reported adverse events in the higher-dose solengepras arm of Cerevance's late-stage trial were headache, urinary tract infection, insomnia, and nausea
- ▪Solengepras was generally well tolerated in Cerevance's late-stage trial, with most adverse events reported as mild or moderate and no serious adverse events reported in the higher-dose arm
How solengepras works
- ▪Unlike standard Parkinson's therapies that target dopamine levels, solengepras inhibits a protein that regulates body coordination and motor function
- ▪By avoiding dopamine pathways, Cerevance aims to improve motor function in Parkinson's patients while preventing dyskinesia, an involuntary jerking motion often caused by standard medications like levodopa
Cerevance company background
- ▪Cerevance was launched in late 2016 as a private, Boston-based joint venture between Lightstone Ventures and Takeda Pharmaceutical, starting with $36 million in funding
- ▪In 2022, Cerevance entered a heavily backloaded collaboration deal with Merck & Co. to identify new protein targets in the brain
Debatable claims
- ▪Targeting non-dopamine pathways is a superior strategy for developing new Parkinson's drugs
- ▪Daily off-time is an inadequate primary metric for evaluating Parkinson's treatments
- ▪Solengepras's 37-minute reduction in daily off-time is clinically significant for Parkinson's patients
- ▪The FDA should approve Cerevance's solengepras for Parkinson's disease
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