Protagonist Therapeutics plans to conduct a two-year extension study, PTG-300-21, to evaluate the long-term effects of rusfertide in patients with polycythemia vera (PV). The decision was based on positive results from the REVIVE study of rusfertide in PV, which showed sustained and durable hematocrit control under 45% in patients who remained largely phlebotomy-free. Nearly 70% of subjects receiving rusfertide treatment met the definition of clinical responders, and more than 92% remained phlebotomy free. Rusfertide is a hormone mimetic-based therapy that selectively targets uncontrolled erythrocytosis.
The announcement comes after Ronald Hoffman, MD, Icahn School of Medicine at Mount Sinai presented late-breaking oral presentation abstract LB2710: Targeted Therapy of Uncontrolled Erythrocytosis in Polycythemia Vera with the Hepcidin Mimetic, Rusfertide - Blinded Randomized Withdrawal Results of the REVIVE Study at the European Hematology Association (EHA) 2023 Congress. The study results will be presented in detail by Marina Kremyanskaya, MD, PhD, Icahn School of Medicine at Mount