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Protagonist Therapeutics Announces Removal of FDA Clinical Hold on the Rusfertide Clinical Development Program
All ongoing clinical trials of rusfertide to resume dosing Phase 3 registrational trial planned to commence in the first quarter of 2022 Conference call
About this update from Protagonist Therapeutics, Inc.
[{"type":"text","content":"All ongoing clinical trials of rusfertide to resume dosing\n Phase 3 registrational trial planned to commence in the first quarter of 2022\n Conference call scheduled for today at 8:00 A.M. ET\n\n\nNEWARK, Calif., Oct. 11, 2021 /PRNewswire/ -- Protagonist Therapeutics, Inc. (Nasdaq: PTGX) (\"Protagonist\" or \"the Company\") today announced that the U.S. Food and Drug Administration (FDA) has removed the full clinical hold on the Company's rusfertide clinical studies, announced on September 17, 2021. Per the FDA, dosing in all clinical studies of rusfertide may be resumed. \nThe Company provided the FDA with all requested information as the basis for a Complete Response and subsequent removal of the clinical hold. In particular, the Company provided the requested individual patient clinical safety reports, updated the investigator brochure and patient informed consent forms, performed a comprehensive review of the most recent safety database, and included new safety and stopping rules in the study protocols. The Company is working closely with study investigators and clinical trial sites to resume dosing of patients in ongoing clinical trials with rusfertide after patients have been reconsented.\nThe clinical hold was initially triggered by a recent non-clinical finding in a 26-week rasH2 transgenic mouse model indicating benign and malignant subcutaneous skin tumors. The rasH2 signal also prompted a re-examination of the four cases of cancer observed across all rusfertide clinical trials involving over 160 patients, and a comprehensive review of the safety database, including cases of suspected unexpected serious adverse reactions (SUSAR). No additional cancer cases, and no other unexpected safety signals, surfaced in this process.\n\"We are extremely pleased that the FDA has acted so quickly in lifting the clinical hold on the rusfertide development program, allowing us to resume patient dosing in our clinical studies,\" said Dinesh Patel, Ph.D., President and Chief Executive Officer of Protagonist. \"Patient safety continues to be our topmost priority. We believe that the cumulative evidence regarding the safety and clinical risk-benefit of rusfertide is supportive of expedited clinical development. We are actively preparing to initiate the phase 3 registrational study for polycythemia vera in the first quarter of 2022. Prota...