Based on a re-read of endoscopy results from a Contract Research Organization (CRO) that revealed errors, Protagonist Therapeutics (NASDAQ:PTGX) will resume clinical development of PRG-100 in ulcerative colitis (UC) patients.
The company terminated its Phase 2b study in March due to an unexpectedly high remission rate in the control group (24%). The re-examined data, showing a much lower placebo effect, demonstrated a dose-dependent treatment benefit.
CEO Dinesh V. Patel, Ph.D. says, “The discontinuation of the PROPEL study was an unfortunate consequence of a human error in the endoscopy readouts provided by the CRO. Based upon an established, safe, and specific mechanism for IBD, PTG-100 offers compelling, patient-focused differentiation by virtue of being an oral drug. We look forward to meeting with the FDA during the second half of 2018 to discuss next steps and plan to present the PROPEL data at a future medical conference. Overall, we also view this data as supportive of the concept of GI-restricted, oral targeted therapy approach for the treatment of IBD. In addition, the most recent financing of $22 million enables us to continue further development of PTG-100.”
Previously: Protagonist bails on mid-stage of PTG-100 in UC (March 26)
Previously: Protagonist Therapeutics secures $22M equity financing (Aug. 6)
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