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Prothena Reports Results from the Phase 3 VITAL Amyloidosis Study of NEOD001 (birtamimab) in AL Amyloidosis
Results from final analysis of the composite primary endpoint were consistent with the futility analysis reported in April 2018Results from post hoc analyses
About this update from Prothena Corporation Plc
[{"type":"text","content":"Results from final analysis of the composite primary endpoint were consistent with the futility analysis reported in April 2018Results from post hoc analyses revealed a potential survival benefit with NEOD001 in the category of patients at the highest risk for early mortality (Mayo Stage IV)Exploring potential business development opportunities to advance NEOD001Investor conference call and webcast scheduled today at 4:30PM ETDUBLIN, Ireland, April 18, 2019 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a clinical-stage neuroscience company, today reported final results from the Phase 3 VITAL Amyloidosis study of NEOD001 (birtamimab) in newly diagnosed, treatment naïve patients with AL Amyloidosis and cardiac dysfunction (N=260), which was discontinued in 2018. The final hazard ratio (HR) for the composite primary endpoint (time to all-cause mortality or time to cardiac hospitalization more than 90 days after first infusion of study drug) of 0.835 (95% CI: 0.5799, 1.2011; p=0.3300) was consistent with the futility analysis reported in April 2018. Post hoc analyses of all-cause mortality revealed a potential survival benefit favoring NEOD001 in the category of patients at highest risk for early mortality (Mayo Stage IV, n=77) with a HR of 0.544 (95% CI: 0.2738, 1.0826; p=0.0787). This potential survival benefit was more pronounced in Mayo Stage IV patients during the initial 12 months of treatment, with a HR of 0.498 (95% CI: 0.2404, 1.0304; p=0.0556).\"We are grateful to patients, their families, investigators and study site staff who made this study, and what we have learned, possible,\" said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. \"Following discontinuation of the VITAL study, we analyzed the results in order to contribute to the body of knowledge about AL amyloidosis with data from this first randomized, placebo-controlled Phase 3 study of an amyloid targeting agent on top of standard of care chemotherapy. These post hoc analyses suggest that in the category of patients at highest risk for early mortality, NEOD001 has the potential to provide a survival benefit on top of standard of care. We are therefore exploring potential business development opportunities that could result in further clinical investigation of NEOD001.\"Phase 3 VITAL Study ResultsThe Phase 3 VITAL study (N=260) ...