PureTech Founded Entity Vedanta Biosciences Announces Phase 2 Study of VE202 in Ulcerative Colitis Did Not Meet Primary Endpoint
VE202 was well tolerated, with no reports of treatment-related serious adverse events
Additional analyses from COLLECTiVE202 to be shared in upcoming scientific forums
Vedanta to focus resources on ongoing Phase 3 RESTORATiVE303 registrational study of VE303 in recurrent Clostridioides difficile infection
Vedanta remains focused on advancing its lead program, VE303, for the prevention of recurrent Clostridioides difficile infection (CDI). Ulcerative colitis and CDI are distinct diseases with different underlying biology, and VE202 and VE303 have different bacterial compositions and mechanisms of action. VE303 has demonstrated positive Phase 2 results, reducing CDI recurrence risk by more than 30% compared with placebo, and is currently being evaluated in the global, registrational Phase 3 RESTORATiVE303 study. The program has received both Fast Track and Orphan Drug designations from the FDA and, if approved, is positioned to become the first live biotherapeutic product for any indication. Vedanta is also advancing VE707, designed to prevent infections caused by multidrug-resistant organisms, with an IND submission planned for 2026.
Over the course of 2025, PureTech’s ownership stake in Vedanta has been diluted to 4.2% on a fully diluted basis.
The full text of the announcement from Vedanta is as follows:
Vedanta Biosciences Announces Phase 2 Study of VE202 in Ulcerative Colitis Did Not Meet Primary Endpoint
VE202 was well tolerated, with no reports of treatment-related serious adverse events
Additional analyses from COLLECTiVE202 to be shared in upcoming scientific forums
Vedanta to focus resources on ongoing Phase 3 RESTORATiVE303 registrational study of VE303 in recurrent Clostridioides difficile infection
“We are very disappointed that our study did not meet its efficacy endpoints, and our greatest regret is that people living with inflammatory bowel disease will not, for now, have the opportunity to benefit from a new treatment option,” said
“Our priority at Vedanta remains the successful execution of our ongoing global pivotal study of VE303 for the prevention of recurrent C. difficile infection, with the goal of potentially delivering the first approved Live Biotherapeutic Product in any indication — and, in doing so, addressing a serious health condition with a significant unmet medical need,” concluded
In the randomized, placebo-controlled COLLECTiVE202 study, endoscopic and clinical responses were assessed using standardized criteria, and the observed response rates in the VE202 group were not statistically different from those in the placebo group. VE202 was generally safe and well tolerated — most adverse events were mild or moderate in intensity, with no reports of treatment-related serious adverse events. Analyses of bacterial colonization, histological findings, and immune responses are ongoing and will be shared in future scientific forums.
Vedanta remains focused on advancing its other pipeline programs:
- VE303: Vedanta is currently enrolling patients into RESTORATiVE303, a registrational Phase 3 study of VE303 for the prevention of recurrent C. difficile infection (rCDI) at over 200 sites in 24 countries. The Phase 3 program is supported by results from a positive Phase 2 study, in which VE303 demonstrated potentially best-in-disease efficacy with a 30.5% absolute risk reduction compared with placebo and greater than 80% reduction in the odds of a CDI recurrence.
- VE707: Vedanta is also advancing VE707 to prevent infections by multidrug-resistant organisms that affect a wide range of vulnerable populations in areas such as oncology, urology, transplantation, and critical care, with IND submission planned for 1H 2026.
About the COLLECTiVE202 Study
COLLECTiVE202 is a double-blind, placebo-controlled, randomized clinical trial conducted at sites in
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Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those related to Vedanta’s development plans, the applicability of the platform, potential benefits to patients, and Vedanta’s and our future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption "Risk Factors" in our Annual Report on Form 20-F for the year ended
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