Ri-CoDIFy Trials Evaluating First-in-Class Treatment for C. Difficile
Ridinilazole is not currently approved for use by any regulatory authority.
Two blinded phase 3 clinical trials will be combined into a single study to evaluate the novel first-in-class treatment ridinilazole versus vancomycin, according to a Summit Therapeutics Inc press release.
Ridinilazole is being analyzed as a first-line therapy for the treatment of initial and recurrent clostridioides difficile (C. diff) infection, with the primary endpoint of establishing the drug’s superiority in sustained clinical response compared to vancomycin. Ridinilazole is not currently approved for use by any regulatory authority.
The pair of phase 3 trials included 753 patients split evenly between each trial. Both of the trials have enrolled more than 50% of their targeted goal, are still blinded, and allow for a prospectively planned analysis, according to the press release.
The commencement of the ridinilazole clinical program and phase 1 of the trial began in 2012, following 100 patients with a phase 2 clinical trial that began in 2014 and the current Ri-CoDIFy phase 3 clinical trials enrolling the first patient in February 2019.
Phase 2 clinical study data were recently released, which included information on ridinilazole and its impact on the gut microbiome as compared to vancomycin and its novel mechanism of action in patients with C. diff, according to the press release.
“On behalf of Team Summit, we would like to express our thanks to each of our investigators, healthcare providers, patients, and the associated facilities, as well as BARDA for their collaboration and support of our clinical trials,” said Robert W. Duggan, Summit’s chairman and chief executive officer, in the press release. “We look forward to concluding these studies and assessing the trial data in the coming months.”
Summit Therapeutics Provides Update on Ri-CoDIFy Trials. Intrado GlobeNewsWire. August 11, 2021. Accessed August 16, 2021. https://www.globenewswire.com/news-release/2021/08/11/2278740/0/en/Summit-Therapeutics-Provides-Update-on-Ri-CoDIFy-Trials.html