Summit Therapeutics completes patient enrollment for SMT19969 Phase 2 trial

Patient dosing and follow-up is underway and the company expects to reveal top-line results later this year.

SMT19969 is a novel, oral antibiotic designed to selectively target C. difficile bacteria. It will not damage the gut microbiome that is required in protecting against disease recurrence.

The annual acute care costs of CDI is expected to be $4.8bn in the US alone. The company said the important clinical issue is disease recurrence with about 25% of patients suffering recurrence of CDI, a risk that increases to 40% after an initial recurrence and over 65% following a second recurrence.

The US Food and Drug Administration granted qualified infectious disease product designation and fast track status to SMT19969.

Summit Therapeutics CEO Glyn Edwards said: "CDI is now widely accepted to be a major healthcare issue, and with current antibiotics used to treat CDI having high rates of disease recurrence, there is an urgent need to develop new therapies.

"We believe SMT19969 represents an important advance as its potency in killing C. difficile bacteria is complemented by selective targeting that leaves the healthy gut microbiome unharmed."

The double- blind, randomized, active control CoDIFy Phase 2 trial is identifying the efficacy of SMT19969 against the existing standard of care, vancomycin.

A total of 100 patients are enrolled under the trial, which is being undertaken in the US and Canada.

Half of the patients received ten days of dosing with SMT19969, and the other receiving ten days of dosing with vancomycin.

The trial intends to find sustained clinical response, a composite endpoint which is defined as clinical cure at the test of cure visit with no recurrence of CDI within 30 days after the end of treatment.

The trial is also evaluating secondary endpoints, including the safety and tolerability of SMT19969 and its impact on patients’ gut microbiome.