Here’s Why Protagonist Therapeutics Popped Today


 
 
06:18 08/06/2018

Protagonist Therapeutics, Inc. [NASDAQ:PTGX ] today announced results from an independent blinded re-analysis of the Phase 2 PROPEL study of oral alpha-4-beta-7 integrin antagonist PTG-100 for the treatment of patients with ulcerative colitis (UC). No safety concerns were noted with PTG-100. The data from blinded endoscopy re-reads and a comprehensive data review provide signals of clinical efficacy and support further development of PTG-100.

In March 2018, Protagonist announced discontinuation of the study following a planned interim analysis conducted by an independent Data Monitoring Committee (DMC). The interim data revealed an unusually high placebo rate of clinical remission (24 percent, approximately four times higher than historical norms for similar UC studies) that led to a futility decision and discontinuation of the trial. A re-read of the endoscopies by the CRO's subcontractor and a subsequent fully blinded re-read of the endoscopies by an independent third party, Robarts Clinical Trials, confirmed that a subset of the initial endoscopy reads provided by the CRO were in error. If the re-read of endoscopy results had been utilized for the interim futility analysis, the trial would have continued. Results of the complete data set as read by Robarts are summarized below. In addition, improvements observed in independent, blinded histological scores favor PTG-100 over placebo and correlate with the clinical remission and endoscopic response outcomes from the re-analysis.

"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. 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."

"It is highly encouraging to see the results that support further study of PTG-100 as there is a clear importance for an oral alpha-4-beta-7 integrin antagonist in expanding the current treatment paradigm," commented William J. Sandborn, M.D., Chief, Division of Gastroenterology, Professor of Medicine at the University of California San Diego School of Medicine. "An oral therapy approach is particularly notable when viewed in the context of advancement in the field, as integrin-targeted therapies begin to replace TNF-targeted therapies in a first line treatment setting for ulcerative colitis. We look forward to the results from upcoming clinical studies of PTG-100 that may allow us to further assess the degree of clinical efficacy and utility for this oral approach on a proven mechanism."


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