Summit Therapeutics PLC (LON:SUMM) (NASDAQ:SMMT) said it has dosed the first patient in the global Phase 3 clinical trials of its precision oral antibiotic, ridinilazole, for C. difficile infection (CDI).
The AIM-listed group, a leader in new mechanism antibiotic innovation, said the Phase 3 trials aim to show superiority of ridinilazole over the standard of care, vancomycin, in a measure that combines CDI cure and recurrence called sustained clinical response (SCR). It pointed out that ridinilazole achieved statistical superiority over vancomycin in SCR in a Phase 2 clinical trial.
Glyn Edwards, chief executive officer of Summit commented: “Starting our Phase 3 programme is an important milestone for Summit. 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.”
The group said the Phase 3 clinical programme comprises two global, randomised, double-blind, active-controlled clinical trials which will be run concurrently with each expected to enrol approximately 680 patients at sites in North America, Latin America, Europe, Australia and Asia.
It added that top-line data from the Phase 3 programme are expected to be reported in the second half of 2021.
The clinical and regulatory development of ridinilazole is being funded in part with Federal funds from the US Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA).
Summit is eligible to receive up to $62mln in funding from BARDA to support the clinical and regulatory development of ridinilazole.