RNS3 Oct 2018 13:09
Summit Highlights Phase 3-Ready Precision Antibiotic Ridinilazole at
IDWeek 2018
-- Ridinilazole in Development to Treat C. difficile Infection and Reduce
Recurrent Disease
Oxford, UK, and Cambridge, MA, US, 3 October 2018 -- Summit Therapeutics
plc (NASDAQ: SMMT, AIM: SUMM), a leader in new mechanism antibiotic
innovation, is highlighting ridinilazole's potential as a front-line
treatment for C. difficile infection ('CDI') in a series of oral and
poster presentations at the infectious disease conference IDWeek 2018 in
San Francisco, CA. Ridinilazole is the Company's most advanced new
mechanism antibiotic, which is expected to enter Phase 3 clinical trials
in the first quarter of 2019.
As are being outlined at IDWeek, the Phase 3 clinical trials of
ridinilazole are designed not only to evaluate ridinilazole in the
treatment of CDI but also to show its impact on reducing disease
recurrence and in preserving the gut microbiome, important determinants
of public health impact. The effectiveness of ridinilazole in the
treatment of CDI and CDI recurrence will be evaluated by measuring
sustained clinical response ('SCR'), which is the primary endpoint for
both of the two planned Phase 3 clinical trials.
"We believe that to have success in antibiotics, we need to be bold and
think differently. This is highlighted by our Phase 3 clinical trial
design for ridinilazole that aims to show superiority of ridinilazole
over vancomycin, the current standard of care. The primary endpoint will
measure how ridinilazole can treat CDI and reduce recurrent CDI, the
major unmet need in this disease. Finally, we are incorporating health
economic outcomes measures that we believe will help support premium
pricing," commented Dr David Roblin, President of R&D of Summit. "If the
Phase 3 clinical trial results are positive, we believe these measures
would differentiate ridinilazole in CDI and support its front-line use."