Summit Therapeutics expects data for Phase 3 ridinilazole program in 2H21
The company said, "Ridinilazole for C. difficile Infection: Ri-CoDIFy Phase 3 landmark clinical trials aim to support registration of the precision antibiotic ridinilazole in the US and other territories, and its adoption as a first-line treatment for CDI by: showing superiority over the current standard of care, vancomycin, using a composite endpoint measuring sustained clinical response; generating health economic data to help support ridinilazole's commercial launch, if approved; and undertaking deep microbiome analyses to evaluate ridinilazole's preservation of the gut microbiome. The Phase 3 clinical programme remains on track for expected reporting of top-line data in the second half of 2021. The trials had enrolled a total of 128 patients as at the end of November 2019 with over two thirds of the 300 planned clinical trials sites having been opened. Reported new Phase 2 clinical trial data that showed ridinilazole improved patients' quality of life compared to vancomycin, including statistically significant improvements in measurements of physical and mental health. Additional data from the Phase 2 clinical trial provided mechanistic insights into how ridinilazole preserved the diversity of the gut microbiome in patients with CDI to maintain the balance of the metabolome of active chemicals made or modified by gut bacteria that help prevent C. difficile recurrence. These new results were reported at the ID Week Conference held in Washington DC in October 2019. Commercial and medical affairs hires have been made in the United States to support work to prepare for a potential launch and to secure future market access for ridinilazole, if approved."