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Prothena Announces Achievement of $60 Million Milestone From Roche for First Patient Dosed in Phase 2b Study of Prasinezumab in Early Parkinson’s Disease
DUBLIN, Ireland, May 10, 2021 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with a robust pipeline of novel
About this update from Prothena Corporation Plc
[{"type":"text","content":"DUBLIN, Ireland, May 10, 2021 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with a robust pipeline of novel investigational therapeutics built on protein dysregulation expertise, today announced that the Company has earned a $60 million milestone from its worldwide collaboration with Roche based on the first patient dosed in the Phase 2b PADOVA study of prasinezumab in patients with early Parkinson's disease. Prothena has previously received $75 million in payments from Roche as part of this collaboration. Prasinezumab is the first anti-alpha synuclein antibody to advance into late-stage clincal development. Results from the Phase 2 PASADENA study, reported in September 2020, demonstrated signals of efficacy on multiple pre-specified secondary and exploratory clinical endpoints, including measures of motor function and biomarkers, in patients with early Parkinson’s disease. These signals of efficacy add to the growing body of evidence that optimally targeting an appropriate epitope within pathogenic proteins, such as alpha-synuclein and abeta, results in clinically meaningful benefits for patients. Roche’s advancement of prasinezumab into this Phase 2b PADOVA study is an important step forward for this first-in-class compound, with the potential to slow the progression of Parkinson’s disease and positively impact the lives of millions of patients. Phase 2b PADOVA Study Design Based on positive signals of efficacy consistent with disease modification in the Phase 2 PASADENA study, prasinezumab is being advanced into the Phase 2b PADOVA study to further assess the efficacy and safety of prasinezumab in an expanded patient population. PADOVA is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of prasinezumab in patients with early Parkinson’s disease who are on stable symptomatic medication. The study will enroll approximately 575 patients, who will be randomized to receive either prasinezumab or placebo via intravenous infusion every 4 weeks. The primary endpoint is time to meaningful progression on motor signs of the disease, as assessed by ≥ 5 point increase from baseline in the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III score. For more information on the Phase 2b PADO...