Protagonist Therapeutics announced the U.S 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 now resume. The Company is working with study investigators and clinical trial sites to resume dosing of patients in ongoing clinical trials with rusfertide after patients have been reconsented.
Protagonist provided the FDA with all requested information as the basis for a Complete Response and subsequent removal of the clinical hold. Specifically, the company submitted 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 hold was triggered by a 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 th...
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