Core Insights - Roche has decided to advance the Phase III development of prasinezumab, an investigational anti-alpha-synuclein antibody, for early-stage Parkinson's disease based on encouraging data from Phase IIb PADOVA and ongoing open-label extensions [1][2] Company Overview - Roche is committed to addressing the substantial need for new treatment options in Parkinson's disease, which currently affects over 10 million people globally [8][9] - The company has a licensing agreement with Prothena to develop monoclonal antibodies targeting aggregated alpha-synuclein, including prasinezumab [7] Clinical Development - The Phase IIb PADOVA study involved 586 participants with early-stage Parkinson's disease, showing potential clinical efficacy in delaying motor progression, although it missed statistical significance [5][6] - Positive trends were observed in reducing motor progression at 104 weeks, indicating a 30-40% relative reduction compared to placebo in both overall and levodopa-treated populations [5] - Ongoing studies, including PASADENA and PADOVA open-label extensions, are evaluating the long-term safety and efficacy of prasinezumab in over 750 participants [3][6] Mechanism of Action - Prasinezumab is designed to bind aggregated alpha-synuclein, potentially reducing neuronal toxicity and slowing disease progression by preventing further accumulation of this protein in the brain [4][9] Industry Context - Parkinson's disease is a chronic and progressive neurodegenerative disorder with no current therapies that can slow or halt its progression, highlighting the unmet medical need for disease-modifying treatments [9][10]
Roche to advance prasinezumab into Phase III development for early-stage Parkinson's disease
Globenewswire·2025-06-16 05:00