Business
Update on Phase 2 PASADENA Study of Prasinezumab (PRX002/RG7935) in Parkinson’s Disease
DUBLIN, Ireland, April 22, 2020 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a clinical-stage neuroscience company with expertise in protein
About this update from Prothena Corporation Plc
[{"type":"text","content":"DUBLIN, Ireland, April 22, 2020 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a clinical-stage neuroscience company with expertise in protein misfolding, announced that today Roche provided an update on Part 1 of the Phase 2 PASADENA study of prasinezumab in patients with early Parkinson’s disease. As updated by Roche during its 1Q20 earnings announcement, the study did not meet the primary objective, but showed signals of efficacy. These signals were observed on multiple prespecified secondary and exploratory clinical endpoints. Roche has begun further clinical development planning activities and is evaluating the data from Part 1 of the PASADENA study to determine next steps. Based on ongoing evaluation of the data, including potential discussions with health authorities, a further update on prasinezumab is expected later this year. The study, which is being conducted by Roche, was designed with 80% power and a one-sided alpha of 0.10 to detect a 37.5% relative between group reduction from baseline to week 52 on the primary endpoint (i.e., the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score (parts I, II and III) vs placebo in Part 1 of the study). Part 2 of the study is ongoing. Prasinezumab was generally well tolerated with a favorable safety profile. Prasinezumab is the focus of a worldwide collaboration between Prothena and Roche. Phase 2 PASADENA Study Design PASADENA is a two-part Phase 2 clinical study in early Parkinson’s disease patients that is being conducted by Roche. Part 1 is a randomized, double-blind, placebo-controlled, three-arm study that enrolled 316 patients to evaluate the efficacy and safety of prasinezumab in patients over 52 weeks. In Part 1, patients were randomized on a 1:1:1 basis to receive one of two active doses (1500 mg or 4500/3500 mg, depending on body weight) of prasinezumab or placebo via intravenous infusion once every 4 weeks. Eligible patients were not on dopaminergic therapy and were not expected to require dopaminergic therapy for at least 52 weeks. Part 2 of the study, which is ongoing, is a 52-week blinded extension phase in which patients from the placebo arm of the study have been re-randomized onto one of two active doses on a 1:1 basis, so that all participants are on active treatment. Patients who were originally randomized ...