Shares in Summit Therapeutics PLC (LON:SUMM; NASDAQ:SMMT) rose sharply after the drug developer outlined plans for the design of the phase III programme for its C. difficile treatment, ridinilazole.
After “constructive” discussions with various regulators including the FDA, Summit said it will design a trial aimed at evaluating the superiority of ridinilazole over the current standard of care C. diff treatment.
“This is something we believe would help differentiate our novel class antibiotic from currently marketed C. difficile treatments and those in late-stage development,” said chief executive Glyn Edwards.
“Superiority in the combined measure of treatment of initial infection and importantly, reduction in recurrence, could position ridinilazole for front-line treatment of C. difficile.”
As Edwards highlighted, a positive phase III result has the potential to support the commercial launch of ridinilazole as a differentiated therapy that can both treat initial C. difficile and reduce disease recurrence.
The phase III programme is expected to include two trials evaluating ridinilazole against the standard of care treatment, vancomycin.
Each trial would enrol around 700 patients with C. difficile, with the primary endpoint being superiority in sustained clinical response (SCR) – an endpoint which measures cure at the end of treatment and a lack of recurrence in the following 30 days.
Other endpoints would include health economic outcome measure, Summit said.
The phase III designs are in-keeping with the successful phase II study, in which ridinilazole achieved “statistical superiority” over vancomycin in SCR.
Summit told investors it hopes to get the trials underway in the first half of next year.
“Our stronger financial position following the DMD programme partnership with Sarepta Therapeutics, Inc. means Summit has more time to fully explore all options,” Edwards added.
“These include potentially entering into a collaboration with a third party or securing meaningful non-dilutive funding from government and charitable organisations.”
Shares were up more than 20%, or 34.5p, on the back of the news to trade at 204.5p.