In the phase II CoDIFy trial, Summit’s drug, Ridinilazole, was more effective than the widely prescribed Vancomycin in preserving the gut microbiome, which is known to be important in protecting both against the initial infection and its recurrence. With this microbiome preservation, ridinilazole treatment resulted in a 59% reduction in recurrence compared to vancomycin (14.3% vs. 34.8%, respectively).”
Ridinilazole also demonstrated clinical and statistical superiority over vancomycin in sustained clinical response, which measures cure and recurrence over thirty days, said Summit.
"These results show how the precision action of ridinilazole against C. difficile, and its corresponding lack of impact on the broader microbiome, led to greatly increased rates of sustained cures through decreased disease recurrence,” said Dr David Roblin, Summit’s President of R&D.
Better prevention of recurrence is the next frontier in CDI therapy, he added.
"Ridinilazole may have the potential to become new standards of care for serious bacterial infections."
The results from the CoDIFy Phase 2 trial were published in the PLOS One journal.
Summit has received financial backing for the drug from the Biomedical Advanced Research and Development Authority (BARDA) in the US and is eligible to receive up to US$62mln in funding to support the clinical and regulatory development of ridinilazole.
Phase 3 clinical trials are expected to begin in the first quarter of next year.
The UK-listed company is pinning its hopes on ridinilazole after ezutromid, its treatment for muscle wasting disease DMD, failed its most recent clinical trial.
In late morning trading, Summit shares were almost 20% higher at 42.5p.
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