Summit Therapeutics expects data for Phase 3 ridinilazole program in 2H21
The company said, "Ri-CoDIFy Phase 3 landmark clinical trials aim to support adoption of the precision antibiotic ridinilazole as the new standard of care 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 analysis that aims to show 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 trial initiation phase is progressing well with 17 countries open for enrolment more than half of the 300 planned clinical trial sites opened, and patient enrolment at 73 and accelerating at the end of September 2019. Reported new Phase 2 clinical trial data that showed ridinilazole improved patients' quality of life compared to vancomycin, including demonstrating statistically significant early and longer-term improvements in measurements of physical and mental health. Additional data highlighted mechanistic insights into how ridinilazole preserves the healthy function of the gut microbiome in patients with CDI. These new results were reported at the ID Week Conference held in Washington DC in early October 2019. BARDA increased the total value of its award supporting the clinical and regulatory development of ridinilazole to up to $63.7M in June 2019. Under this award, BARDA exercised a $9.6M option related to patient enrolment and dosing in the Phase 3 clinical trials, bringing the total committed funding to $53.6M."