Cerevance has announced that interim data from its Phase 2 trial of Solengepras—an investigational, non-dopaminergic therapy for Parkinson’s disease—showed a statistically significant reduction in daily “OFF” time (periods when standard medications wear off and symptoms return) when Solengepras was added to existing therapy.
In the double-blind Phase 2 study, patients treated with daily 150 mg solengepras saw an average reduction of 1.3 hours per day in OFF time compared with placebo after 27 days (p = 0.02).
In a subgroup of patients who had three or more hours of OFF time at baseline (about 88 % of participants), the treatment effect was more pronounced: 1.78 hours off time reduced versus placebo (p = 0.0045), representing a 34.7% improvement from baseline (p = 0.0026). The number of OFF episodes per day also decreased by nearly one episode versus placebo (p = 0.0026), and duration of each OFF period showed a trend toward reduction.
Solengepras was well tolerated, with a low incidence of dopaminergic-related side effects. According to the company, this once-daily oral GPR6 inhibitor could offer a novel, non-dopaminergic option to reduce motor fluctuations in Parkinson’s patients who rely on levodopa or similar therapies.
Based on these promising results, Cerevance is already running the global Phase 3 ARISE trial—testing solengepras as an adjunctive therapy to standard Parkinson’s treatments, with ~330 patients enrolled worldwide.
