Cerevance announced topline results from its Phase 2 ASCEND trial of solengepras, a non-dopaminergic drug candidate for early-stage, untreated Parkinson’s disease. While the trial did not achieve statistical significance on its primary endpoint of motor symptom improvement, it showed potential benefits in functional and non-motor symptoms, along with a favorable safety profile. The ongoing Phase 3 ARISE trial, evaluating solengepras as an add-on therapy, is expected to provide further insights.
Current Parkinson’s treatments primarily focus on dopamine replacement, often leading to diminishing returns and side effects over time. Solengepras’s novel mechanism of action, targeting GPR6 to modulate brain circuits without directly affecting dopamine pathways, offers a potential alternative approach to managing both motor and non-motor symptoms, a significant unmet need for patients. Addressing non-motor symptoms, which can substantially impact quality of life, is a crucial area of Parkinson’s research where current therapies often fall short. Solengepras’s potential to alleviate these symptoms, if confirmed in larger trials, could significantly improve patient well-being.
The Phase 2 ASCEND trial involved 64 patients randomized to solengepras 150mg or placebo daily for 12 weeks. Although the primary endpoint, measured by the MDS-UPDRS Parts II+III, was not met, trends toward improvement were noted in patient-reported measures like MDS-UPDRS Part I and II, the Non-Motor Symptoms Scale, and the Epworth Sleepiness Scale. Importantly, solengepras demonstrated good tolerability with no serious adverse events and a lower incidence of non-motor symptom-related adverse events compared to placebo.
The positive signals from the ASCEND trial, particularly regarding non-motor symptoms, suggest that solengepras may offer a valuable new treatment option for Parkinson’s disease. The upcoming Phase 3 ARISE trial, focusing on solengepras as an adjunctive therapy, will be critical in determining the drug’s true efficacy and potential to address the unmet needs of Parkinson’s patients. These results may significantly reshape the treatment landscape for Parkinson’s disease by offering a non-dopaminergic approach and focusing on holistic symptom management.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
