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News
A phase 3 trial of solengepras, a potential first-in-class non-dopaminergic therapy, hit its primary endpoint in Parkinson's disease. The drug reduced daily "OFF" time by 0.61 hours compared to placebo at 12 weeks, with benefits appearing as early as week 2. The company plans to discuss regulatory submission with the FDA.
A new treatment approach for Parkinson's disease (PD) is showing real promise. The phase 3 ARISE trial evaluated solengepras — a novel, non-dopaminergic therapy — as an add-on treatment for PD patients struggling with motor fluctuations. Unlike traditional PD drugs that work on dopamine pathways, solengepras selectively inhibits GPR6 receptors to restore balance in the basal ganglia, offering a genuinely new mechanism of action.
The trial enrolled 341 patients who experienced at least 3 hours of daily "OFF" time (periods when medication isn't working well). Participants received solengepras 75mg, 150mg, or placebo once daily for 12 weeks. The 150mg dose met both the primary and key secondary endpoints, with a strong 91% trial completion rate.
By the Numbers:
Why it matters: Motor fluctuations are one of the most debilitating aspects of PD, and current therapies are limited to dopaminergic approaches. Solengepras could become the first non-dopaminergic adjunctive option, giving clinicians a new tool — especially for patients who aren't well-controlled on existing regimens. Cerevance plans to engage the FDA on next steps for regulatory submission.
