- Roche to advance prasinezumab to Phase III trials for early-stage Parkinson’s disease.
- Phase IIb PADOVA study suggests potential clinical benefits for prasinezumab.
- Prasinezumab targets alpha-synuclein, a driver of Parkinson's disease progression.
Prothena Corporation plc (PRTA, Financial) has announced that its partner, Roche, will move prasinezumab into Phase III development aimed at early-stage Parkinson’s disease. This decision is based on promising data from the ongoing Phase IIb PADOVA study and open-label extensions from both the PADOVA and Phase II PASADENA studies. Over 750 participants are involved in these studies examining the long-term safety and efficacy of prasinezumab.
Prasinezumab is an investigational monoclonal antibody designed to target aggregated alpha-synuclein, potentially reducing neuronal toxicity associated with Parkinson’s disease progression. According to data from the PADOVA study, prasinezumab demonstrated potential clinical efficacy in the primary endpoint of time to confirmed motor progression with a hazard ratio (HR) of 0.84 (95% CI: 0.69-1.01), although it missed statistical significance (p=0.0657). Notably, in a subgroup treated with levodopa (75% of participants), the HR was 0.79 (95% CI: 0.63-0.99), with a nominal p-value of 0.0431.
Positive trends towards reduced motor progression were observed at 104 weeks (two years), showing a 30-40% relative reduction versus placebo in both the overall and levodopa-treated populations. Prasinezumab continues to be well-tolerated, with no new safety signals reported. The safety database includes data from more than 900 participants treated with the investigational drug, over 500 of whom have been treated for 1.5-5 years.
Since December 2013, Prothena and Roche have collaborated to develop and commercialize antibodies targeting alpha-synuclein, including prasinezumab. The financial arrangement includes up to double-digit teen royalties on net sales and Prothena earning up to $620 million in additional milestone payments, of which $135 million has already been received.
Parkinson's disease, affecting over 10 million people globally, lacks therapies that slow or stop progression, highlighting the potential impact of prasinezumab as a first disease-modifying treatment.
