Roche's Prasinezumab Heads to Phase III for Early-Stage Parkinson's

• Roche advances prasinezumab to Phase III for early Parkinson's
• Phase II trials show encouraging efficacy and strong safety signals
• Biomarker data shows impact on Parkinson's disease biology

Roche has reported it will move prsazinezumab, its investigational anti-alpha-synuclein antibody, into Phase III development for early-stage Parkinson’s disease following an assessment of data from its Phase IIb PADOVA study and ongoing open-label extensions (OLEs) of both PADOVA and the prior PASADENA study.

According to Dr. Levi Garraway, Roche’s Chief Medical Officer, the company observed promising efficacy signals across these studies, with a consistent safety profile. “The data give early signals that prasinezumab could be the first disease-modifying therapy for Parkinson’s,” he said.

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Although prasinezumab did not reach statistical significance in the primary endpoint of time to confirmed motor progression, the PADOVA study did show some encouraging trends in slowing disease progression over 104 weeks. Further, OLE data suggest that the effects could be lasting over the longer term. The study also provided the first biomarker evidence of prasinezumab impacting Parkinson’s disease biology.

The OLE studies of PASADENA and PADOVA involve over 750 early-stage Parkinson’s patients and are still ongoing, and will continue to evaluate the long-term safety and efficacy of prasinezumab.