Protagonist Therapeutics Inc. (NASDAQ: PTGX)announced the results of an independent, blinded re-analysis of the Phase 2 PROPEL study of oral alpha-4-beta-7 integrin antagonist PTG-100 for ulcerative colitis. The drug was previously in its Phase IIb trial before being discontinued due to initial endoscopy reads provided by the Contract Research Organization (CRO) being faulty.
The Company had the endoscopy results re-read by Robarts Clinical Trials, which confirmed that the CRO had made an error and that if the re-reads were used instead, the trial would have continued.
“The discontinuation of the PROPEL study was an unfortunate consequence of a human error in the endoscopy readouts provided by the CRO,” commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. “Based upon an established, safe, and specific mechanism for IBD, PTG-100 offers compelling, patient-focused differentiation by virtue of being an oral drug.”
The Company has also secured a USD 22 Million equity financing that will be used towards furthering the development of PTG-100. Following the announcement of the re-continuation of PTG-100, shares of the Protagonist Therapeutics soared over 55% Monday.
According to the Company’s press release, Protagonist will work with the U.S. Food and Drug Administration (FDA) in the second half of 2018 to discuss the next steps and plan to present the PROPEL data at a future medical conference.