Protagonist Therapeutics and Takeda announced positive topline results from the Phase 3 VERIFY study of rusfertide in phlebotomy-dependent patients with polycythemia vera (PV). The study successfully met its primary endpoint, demonstrating a significantly higher proportion of clinical responders on rusfertide compared to placebo.
All four key secondary endpoints were also met, including the EU primary endpoint and patient-reported outcomes, indicating broad efficacy. Rusfertide, a first-in-class investigational hepcidin mimetic peptide therapeutic, was generally well tolerated with no new safety findings observed.
Following these positive results, Protagonist earned a $25 million milestone payment under its license and collaboration agreement with Takeda. This successful Phase 3 outcome marks a critical inflection point for Protagonist's hepcidin program and validates its peptide-based medicine platform.
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