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Protagonist Therapeutics Announces Initial Phase 2 Results with Hepcidin Mimetic PTG-300 in the Treatment of Polycythemia Vera
-- PTG-300 treatment demonstrates robust clinical response and provides clinically meaningful dose related control of hematocrit values on individual patient
About this update from Protagonist Therapeutics, Inc.
[{"type":"text","content":"-- PTG-300 treatment demonstrates robust clinical response and provides clinically meaningful dose related control of hematocrit values on individual patient basis --\n -- Results to be presented today by Ronald Hoffman, M.D., Director of the Myeloproliferative Diseases Program at The Icahn School of Medicine at Mount Sinai --\n\n\nNEWARK, Calif., May 7, 2020 /PRNewswire/ -- Protagonist Therapeutics, Inc. (Nasdaq:PTGX) today announced initial data from the ongoing Phase 2 study of PTG-300 in patients with polycythemia vera. The current results demonstrate that treatment with PTG-300 at individualized doses ranging from 10 mg to 80 mg for up to 28 weeks provided dose-related control of hematocrit levels and eliminated the need for phlebotomy in all six out of six patients that received the dosing as per protocol. A seventh patient with 12 weeks of treatment had an unintended dose interruption, received a single phlebotomy, and remains on the study. In addition, positive symptomatic measurements related to the ability of PTG-300 to address iron deficiency in these frequently phlebotomized patients were observed, with increases in serum ferritin values approaching the range observed in healthy subjects. Patients enrolled in the current study had received at least three phlebotomies within a 24 week period prior to PTG-300 treatment and were treated for up to 28 weeks as of the cutoff date of May 1, 2020 (range of 4 to 28 weeks, n=7 evaluable for efficacy). Enrollment in the study continues and a total of eight patients have enrolled to date.\n\n \n \n \n \n \n \n\n \n\"While further follow up and data from additional patients will be needed to confirm the continuity of the robust clinical responses observed to date, we believe that this study provides a compelling rationale to initiate planning for a pivotal program in polycythemia vera,\" commented Samuel Saks, M.D., Protagonist Chief Medical Officer. \"As a peptide mimetic of the natural hepcidin hormone, PTG-300 is believed to limit the excess number of red blood cells in polycythemia vera by reducing iron available for red blood cell production. In the near term, we are expanding the current study to include additional patients as the Company focuses on these encouraging results. We will also be hosting a scientific planning meeting with leaders in the field of myeloproliferati...