Rusfertide Meets Primary Endpoint in Clinical Trial for PV patients

Protagonist Therapeutics, Inc., announced 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.

In patients with moderate or severe Myeloproliferative Neoplasm-Symptom Assessment Form (MPN-SAF) symptom scores at baseline, the change from baseline was statistically significant in fatigue, problems with concentration, inactivity and itching during the 28-week open label Part 1 of the study.

Rusfertide was well tolerated, with localized injection site reactions comprising the most reported adverse events.

"These randomized withdrawal data from the REVIVE study indicate a dramatic difference in the experience of the treatment group versus the placebo group," noted Dr. Ronald Hoffman, M.D., the Albert A. and Vera G. List Professor of Medicine (Hematology and Oncology), Director of the Myeloproliferative Research Program at the Icahn School of Medicine at Mount Sinai, and principal investigator of the study. "With robust and strongly positive results observed across a diverse set of patients, we have further confirmation of rusfertide's potential to serve as an essential future treatment option for patients with polycythemia vera.

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