Proactive Investors - Run By Investors For Investors

Summit Therapeutics says first patient dosed in global Phase 3 clinical trials for its precision oral antibiotic, ridinilazole

The Phase 3 programme comprises two global, randomised, double-blind, active-controlled clinical trials which will be run concurrently with each expected to enrol around 680 patients
Clinical trials
Summit said top-line data from the Phase 3 programme are expected to be reported in the second half of 2021

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.

WATCH: Summit Therapeutics to begin Phase 3 studies of ridinilazol this quarter

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.

View full SUMM profile View Profile

Summit Therapeutics PLC Timeline

Related Articles

copd radiograph
April 02 2019
City broker Peel Hunt reckons the recent approvals “support the top-line forecasts in our model that should see Circassia achieve EBITDA positivity in 2020”
Alliance
April 05 2019
Chief executive Peter Butterfield said the company has started 2019 well-positioned for growth after a strong performance in 2018.
A doctor's stethoscope and a marijuana plant
February 22 2019
With top-line data from the CONNECT-FX trial on the way, investors are eying the opportunity defined by marijuana-adjacent companies like Zynerba Pharmaceuticals

© Proactive Investors 2019

Proactive Investors Limited, trading as “Proactiveinvestors United Kingdom”, is Authorised and regulated by the Financial Conduct Authority.
Registered in England with Company Registration number 05639690. Group VAT registration number 872070825 FCA Registration number 559082. You can contact us here.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use