PureTech Founded Entity Vedanta Biosciences Enrolls First Patient in Pivotal Phase 3 RESTORATiVE303 Study of VE303 for the Prevention of Recurrent C. difficile Infection

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company, noted today that its Founded Entity, Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, announced that the first patient has been dosed in the global Phase 3 RESTORATiVE303 clinical study of VE303, which is an orally administered defined bacterial consortium candidate that is being developed for the prevention of recurrent C. difficile infection (rCDI). The RESTORATiVE303 trial is evaluating the efficacy and safety of VE303 in patients with rCDI and is intended to form the basis for a Biologics License Application to be filed with the U.S. Food and Drug Administration.

The full text of the announcement from Vedanta is as follows:

Vedanta Biosciences Enrolls First Patient in Pivotal Phase 3 RESTORATiVE303 Study of VE303 for the Prevention of Recurrent C. difficile Infection

VE303 is an orally administered, potential first-in-class live biotherapeutic product candidate being developed to prevent recurrence of Clostridioides difficile infection (CDI)

CAMBRIDGE, MA, May 21, 2024 – Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced that the first patient has been dosed in the global Phase 3 RESTORATiVE303 clinical study. VE303 is an orally administered defined bacterial consortium candidate that is being developed for the prevention of recurrent C. difficile infection (rCDI). The RESTORATiVE303 trial is evaluating the efficacy and safety of VE303 in patients with rCDI and is intended to form the basis for a Biologics License Application (BLA) to be filed with the U.S. Food and Drug Administration.

“Initiation of the RESTORATiVE303 study represents a key clinical milestone for the VE303 program. Building on the successes of earlier VE303 clinical studies, RESTORATiVE303 is the first pivotal Phase 3 study of a live biotherapeutic product for prevention of recurrent CDI, a potentially serious infection that affects up to 175,000 patients and results in approximately 20,000 deaths annually in the U.S.,” said Jeffrey Silber, M.D., Chief Medical Officer of Vedanta Biosciences. “Based on the efficacy and safety data we have generated to date for this program, we believe that an oral, rationally designed, defined consortium candidate has the potential to offer patients with rCDI an attractive alternative to undefined, donor-derived fecal approaches.”