Cerevance's Parkinson's Drug Fails in Phase 2 Monotherapy Trial, Phase 3 Results Awaited

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Cerevance's Parkinson's Drug Fails in Phase 2 Monotherapy Trial, Phase 3 Results Awaited

Cerevance, a Boston-based biotech company, has announced disappointing results from its phase 2 clinical trial of solengepras, a GPR6 inverse agonist, in early, untreated Parkinson's disease patients. The drug failed to meet its primary endpoint, performing no better than placebo on the MDS-UPDRS Parkinson's clinical rating scale at Week 12.

Trial Results and Company Response

The phase 2 monotherapy study aimed to evaluate solengepras as a potential first-line treatment for Parkinson's disease. Despite the primary endpoint miss, Cerevance's CEO Craig Thompson attempted to frame the results in a positive light, highlighting "trends in improvement" on patient-reported measures.

"The data align with findings from our phase 2 adjunctive therapy trial, with both studies demonstrating benefits on patient-reported measures," Thompson stated. He added that solengepras "appears to be more effective in impacting the functional and non-motor symptoms captured by patient-reported outcomes."

Safety Profile and Ongoing Studies

The trial revealed no significant safety concerns for solengepras. All patients in the treatment arm completed the study, and no participants experienced serious adverse events related to the drug.

Despite this setback, Cerevance is continuing its phase 3 trial of solengepras as an adjunctive therapy to levodopa in Parkinson's patients experiencing motor fluctuations. The primary endpoint of this ongoing study focuses on motor symptoms as reported in patient diaries, with several secondary endpoints also capturing patient-reported measures.

Looking Ahead

The pharmaceutical industry will be closely watching for the results of Cerevance's phase 3 adjunctive therapy trial, expected in the first half of next year. These findings will be crucial in determining the future of solengepras and its potential role in Parkinson's disease treatment.

As the search for effective Parkinson's therapies continues, the outcome of this trial underscores the challenges facing drug developers in this complex neurological field. The contrast between physician-administered assessments and patient-reported outcomes also raises questions about the most appropriate measures for evaluating the efficacy of Parkinson's treatments.

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