Baseline Data from Phase 2 PASADENA Study of Prasinezumab (PRX002/RG7935) in Parkinson’s Disease to be Presented at AAT-AD/PD

DUBLIN, Ireland, March 31, 2020 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a clinical-stage neuroscience company with expertise in protein misfolding, today announced that baseline data from the Phase 2 PASADENA study of prasinezumab in patients with early Parkinson’s disease will be presented by Roche in an oral presentation at the Advances in Alzheimer’s and Parkinson’s Therapies AAT-AD/PD Focus Meeting (AAT-AD/PD), to be held virtually on April 2-5, 2020. Prasinezumab, a monoclonal antibody under development for the potential treatment of Parkinson's disease, is the focus of a worldwide collaboration between Prothena and Roche.

Baseline data from the Phase 2 PASADENA study of prasinezumab in patients with early Parkinson's disease, will be presented in the following virtual oral session. The presentation will subsequently be posted on www.prothena.com under the Investors tab in the Events and Presentations section:

A Phase 2 study to evaluate the safety and efficacy of prasinezumab in early Parkinson's disease (PASADENA): rationale, design and baseline data

• Presenter: Dr. Gennaro U. Pagano, Translational Medicine Leader and Senior Principal Medical Director in Neuroscience, Roche
  
  
• Session: #20
  
  
• Date and Time: Virtual oral presentation — April 3, 2020, Session Time 5:10 PM – 7:10 PM CET

Phase 2 PASADENA Study Design

PASADENA is a two-part Phase 2 clinical study in patients with early Parkinson’s disease 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 to an active dose will continue at that dose level for the additional 52 weeks. In Part 2, patients are allowed to use concomitant dopaminergic therapy. Any patient who medically required initiation of dopaminergic therapy during Part 1 have had their subsequent data censored for the primary endpoint analysis.