- Phase 3 VERIFY study shows rusfertide significantly reduces phlebotomy needs and improves hematocrit control in polycythemia vera patients.
- Clinical response more than doubled with rusfertide, achieving 76.9% compared to 32.9% with placebo.
- Rusfertide receives Orphan Drug and Fast Track designations from the U.S. FDA.
Protagonist Therapeutics, Inc. (PTGX) and Takeda (TAK, Financial) have announced the successful results from the Phase 3 VERIFY study, which evaluated the efficacy of rusfertide in patients with polycythemia vera (PV). The results were presented at the 61st American Society of Clinical Oncology (ASCO) Annual Meeting Plenary Session.
Rusfertide, a first-in-class hepcidin mimetic peptide therapeutic, demonstrated a significant reduction in phlebotomy eligibility, achieving a clinical response in 76.9% of patients compared to 32.9% in the placebo group. The study showed a reduction in phlebotomies and improved hematocrit control, with only 27% of patients requiring phlebotomy in the rusfertide arm versus 78% in the placebo arm.
The study also reported no serious adverse events related to rusfertide, highlighting its potential as a safe and effective treatment for PV. The FDA has granted rusfertide both Orphan Drug and Fast Track designations, supporting its further regulatory advancements.
These findings position rusfertide as a promising treatment option that could be integrated into the standard of care for PV patients, especially those not achieving adequate hematocrit control with existing therapies. Protagonist and Takeda continue to collaborate towards the potential approval and commercialization of rusfertide, aiming to enhance the treatment landscape for PV patients worldwide.
