UK-based Summit Therapeutics has started dosing in its Phase III clinical trial of antibiotic ridinilazole for the treatment of Clostridium difficile (C. difficile) infection (CDI).
Ridinilazole is an oral small molecule developed to selectively destroy C. difficile bacteria and preserve patients’ protective gut microbiome, as well as ensure sustained CDI cures.
The Phase III programme consists of two trials that will evaluate the antibiotic’s superiority over the standard of care vancomycin as the primary endpoint.
The measure for superiority involves a combination of CDI cure and recurrence, sustained clinical response (SCR), within 30 days after treatment.
Secondary endpoints of the trials include cure and SCR at 60 days and 90 days following treatment. They will also evaluate additional endpoints such as the impact on the gut microbiome.
The trials also include health economic outcome measures such as readmission rates and length of hospital stay in order to support ridinilazole's commercialisation, if approved.
Both the global, randomised, double-blind, active-controlled trials will be performed concurrently and will recruit around 680 patients each, at centres across North America, Latin America, Europe, Australia and Asia.
Top-line results from the Phase III programme are expected to be available in the second half of 2021.
Summit Therapeutics CEO Glyn Edwards said: “With positive results, we believe ridinilazole could be positioned as the drug of choice in the front-line treatment of CDI, which potentially provides patients with sustained cures and hospitals with compelling cost savings.”
Findings from a Phase II proof of concept trial demonstrated statistical superiority of ridinilazole in SCR rates, compared to vancomycin.
The antibiotic was also observed to be highly preserving of the gut microbiome.