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Summit Therapeutics Provides Update on Ri-CoDIFy Trials
Cambridge, Massachusetts, Aug. 11, 2021 (GLOBE NEWSWIRE) -- Based on a thorough review of the design and enrollment status of two ongoing blinded Phase III
About this update from Summit Therapeutics Inc.
[{"type":"text","content":"Cambridge, Massachusetts, Aug. 11, 2021 (GLOBE NEWSWIRE) -- Based on a thorough review of the design and enrollment status of two ongoing blinded Phase III Ri-CoDIFy trials, Summit Therapeutics Inc. (NASDAQ: SMMT) today announced that it will combine its two blinded pivotal Phase III clinical trials evaluating ridinilazole versus vancomycin into a single study. Ridinilazole, a novel first-in-class drug, is currently under investigation for use as first-line therapy for the treatment of initial and recurrent Clostridioides difficile infection. The trial’s primary endpoint seeks to prove ridinilazole’s superiority in sustained clinical response as compared to vancomycin. Ridinilazole is not currently approved for use by any regulatory authority. Current enrollment in the two Ri-CoDIFy Phase III trials is 753 patients, split approximately evenly between each of the two trials. This enrollment level offers a unique opportunity to combine the studies, as the two ongoing trials have enrolled just over 50% of their targeted goal, are still blinded, and allow for a prospectively planned analysis. “In spite of a worldwide healthcare, COVID-19 pandemic-driven crisis and an unprecedented challenge in enrolling patients in clinical trials in the current setting, we are proud of the enrollment achieved within these two clinical trials,” said Dr. Maky Zanganeh, Summit’s Chief Operating Officer and a Director of the company. “In the best interest of all Summit and Ri-CoDIFy study stakeholders, including patients, physicians, hospitals, and other facilities providing care for patients with infectious diseases, the correct and appropriate action to take at this time is to prospectively plan to combine the two Ri-CoDIFy trials and to analyze the data. A positive result from the combined study could form the basis of a presentation of the trial results to the regulatory authorities and inform further decisions on next steps.” The ridinilazole clinical program commenced with the Phase I trial beginning in 2012, a 100-patient Phase II clinical trial began in 2014, and the current Ri-CoDIFy Phase III clinical trials enrolled the first patient in February 2019. The company recently released breakthrough Phase II clinical study data, including the relative sparing of ridinilazole on the gut microbiome as compared to vancomycin, ridinilazole’s minimal i...