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Protagonist Announces Positive Results from REVIVE for PV

Protagonist Therapeutics, Inc. announces positive topline results from the blinded, placebo-controlled, randomized withdrawal portion of REVIVE, a study evaluating rusfertide, a subcutaneous injectable hepcidin mimetic, in patients with polycythemia vera (PV).


Subjects receiving rusfertide achieved highly statistically significant improvements versus placebo in the primary endpoint. The double-blind, placebo-controlled, 12-week randomized withdrawal phase was included as Part 2 of the REVIVE study to evaluate rusfertide in PV patients with frequent phlebotomy requirements.


Rusfertide was well tolerated, with localized injection site reactions comprising the majority of reported adverse events. No new safety signals were observed in these data following presentation of safety data from the REVIVE study at the American Society of Hematology (ASH) December 2022 Annual Meeting.


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