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Protagonist Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Update
Resumption of the Phase 2 study of rusfertide in polycythemia vera now underway, following swift removal of the FDA clinical hold Positive proof-of-concept
About this update from Protagonist Therapeutics, Inc.
[{"type":"text","content":"Resumption of the Phase 2 study of rusfertide in polycythemia vera now underway, following swift removal of the FDA clinical hold\n Positive proof-of-concept data for rusfertide in hereditary hemochromatosis to be presented at The Liver Meeting® hosted by the American Association for the Study of Liver Diseases\n PN-235 moves into a psoriasis indication, Phase 2 study initiation planned for early 2022\n\n\nNEWARK, Calif., Nov. 3, 2021 /PRNewswire/ -- Protagonist Therapeutics, Inc. (Nasdaq: PTGX) (\"Protagonist\" or \"the Company\") today reported its financial results for the third quarter ended September 30, 2021 and provided a corporate update.\n\"We are excited to share the substantial progress made thus far in all of our clinical programs, highlighted by the presentation of proof-of-concept data on rusfertide in hereditary hemochromatosis at the upcoming AASLD meeting, and the new rusfertide data in polycythemia vera, which will be presented by the year's end,\" said Dinesh V. Patel, Ph.D., President and Chief Executive Officer. \"We were very pleased that the FDA reached a swift resolution regarding the clinical hold placed on rusfertide, and we are in the process of resuming all rusfertide clinical studies. Additionally, we are highly encouraged with the rate of enrollment in the Phase 2 study of our oral alpha-4-beta-7 integrin antagonist PN-943, for ulcerative colitis, an indication with a large patient population and unmet treatment need. We maintain our guidance of a data readout in Q2 2022, and in anticipation of this, we are excited that Dr. Scott Plevy has joined our team as Executive Vice President and Therapeutic Head, Gastroenterology. As a renowned gastroenterologist, Dr. Plevy will oversee the clinical development of PN-943 and other future programs focused on gastrointestinal diseases. Finally, our oral IL-23 receptor antagonist program, in partnership with Janssen, continues to make demonstrated progress, with PN-235 now advancing into a Phase 2 study in psoriasis in early 2022.\"\nThird Quarter 2021 Recent Developments and Upcoming Milestones\nRusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders\nOn October 11, 2021, Protagonist announced that the U.S. Food and Drug Administration (FDA) removed the full clinical hold on rusfertide's clinical studies after ...