Roche Advances Prasinezumab To Phase III Trials For Early-Stage Parkinson’s Disease, Marking Key Step In Neurodegenerative Drug Development

Roche has announced its decision to advance prasinezumab, an investigational anti-alpha-synuclein antibody, into Phase III clinical development for the treatment of early-stage Parkinson’s disease. This move follows the analysis of data from the Phase IIb PADOVA study, along with findings from ongoing open-label extensions (OLEs) of both the PADOVA and earlier Phase II PASADENA trials.

Although the PADOVA study did not achieve statistical significance in its primary endpoint time to confirmed motor progression prasinezumab demonstrated promising signs of clinical benefit when used alongside existing symptomatic treatments. Notably, trends suggested a reduction in motor progression over a two-year treatment period, and these effects appear to be maintained over longer durations based on further data from the OLEs. These findings point to a potential disease-modifying effect of prasinezumab, marking a critical step forward in Parkinson’s research.

Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Roche, said in a statement, "We are encouraged by the efficacy signals observed across the two phase II trials and their open-label extensions, combined with the favourable safety and tolerability profile of prasinezumab. We also recognise the substantial need for new treatment options, and the totality of data suggest that prasinezumab may have the potential to become the first disease-modifying treatment for people with Parkinson’s disease."

The PADOVA study also yielded the first biomarker evidence that prasinezumab may influence the underlying disease biology, further supporting its continued development. Combined, the PASADENA and PADOVA open-label extension studies are assessing the long-term safety and efficacy of prasinezumab in more than 750 individuals with early-stage Parkinson’s disease. Roche’s decision to move into Phase III trials underscores its ongoing commitment to exploring innovative therapies aimed at slowing disease progression and improving the quality of life for patients living with Parkinson’s.