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Protagonist Therapeutics Announces Updated Phase 2 Data Supporting Long-Term Efficacy of Rusfertide in Polycythemia Vera
Rusfertide demonstrated sustained hematocrit control, reversal of iron deficiency, and a reduction in phlebotomies, for up to 18 months, in both high risk and
About this update from Protagonist Therapeutics, Inc.
[{"type":"text","content":"Rusfertide demonstrated sustained hematocrit control, reversal of iron deficiency, and a reduction in phlebotomies, for up to 18 months, in both high risk and low risk patients\n Data from 63 patients were presented during an oral presentation session at the European Hematology Association 2021 Virtual Congress\n Management to host an investor conference call and webcast today at 8:00 a.m. ET\n\n\n\n NEWARK, Calif., June 11, 2021 /PRNewswire/ -- Protagonist Therapeutics (Nasdaq:PTGX) (\"Protagonist\" or \"the Company\") today announced updated results from the ongoing Phase 2 study of rusfertide, an investigational new drug being evaluated for the treatment of polycythemia vera (PV). These data were presented in an oral presentation today at the European Hematology Association (EHA) 2021 Virtual Congress.\n\"This data set cumulatively builds on previously presented scientific evidence demonstrating rusfertide's potential as the first-in-class, non-cytoreductive treatment option for polycythemia vera, a disease that currently has limited therapeutic options and a demonstrated significant unmet medical need,\" said Dinesh Patel, Ph.D., President and Chief Executive Officer of Protagonist. \"The possibility of advancing PV treatment beyond the current standard of care is compelling to patients and the medical community. The durability of effect and symptom improvements being observed in our fully enrolled Phase 2 study, along with the recent Breakthrough Therapy Designation from the FDA, provides further support for the advancement of rusfertide into Phase 3 clinical development in early 2022.\" \nSummary of Results:\nTherapeutic phlebotomies were essentially eliminated and a target hematocrit of less than 45 percent was maintained for the vast majority of patients treated with rusfertide Rusfertide demonstrated long-term control of hematocrit, as well as durability of effect based on patients treated up to 18 months Rusfertide treatment also led to reversal of iron deficiency as evidenced by increasing serum ferritin, mean corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH) values Rusfertide demonstrated similar efficacy in all patients, independent of risk group or prior and concurrent therapy Benefits were observed in patient reported outcomes, as shown by improvement in PGI-C and reduction in MPN-SAF Symptom Scores, ...