TOKYO (dpa-AFX) - Protagonist Therapeutics, Inc. (PTGX) and Takeda (TAK) announced new 52-week results from the pivotal Phase 3 VERIFY study of rusfertide in patients with polycythemia vera (PV). The data, presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, highlight rusfertide's sustained efficacy and safety, with 61.9% of patients continuously treated maintaining absence of phlebotomy eligibility from baseline to Week 52. No new safety signals were observed.
These longer-term findings build upon the 32-week primary analysis, which met its primary efficacy endpoint and all four key secondary endpoints. Patients who crossed over from placebo to rusfertide at Week 32 achieved comparable outcomes to those initially randomized to rusfertide, with 77.9% achieving absence of phlebotomy eligibility between Weeks 40-52.
Additional results from the combined REVIVE and THRIVE long-term extension studies demonstrated a 13-fold reduction in the annual rate of phlebotomies from baseline over four years, underscoring rusfertide's durable benefit in PV management.
Achieving and maintaining hematocrit (HCT) levels below 45% is the primary treatment goal in PV to reduce thrombotic risk and alleviate symptoms. Many patients remain phlebotomy-dependent despite current standard therapies. The VERIFY study was designed to evaluate rusfertide's ability to address this unmet need, and the 52-week data reinforce its potential as a new addition to the standard of care for PV.
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