Vedanta’s Live Bacteria Cocktail Fails Phase 2 Ulcerative Colitis Trial

Vedanta Biosciences, a clinical-stage biopharmaceutical company pioneering oral microbiome-based therapies, today announced that its investigational candidate VE202 did not meet the primary efficacy endpoint in the Phase 2 COLLECTiVE202 study for mild-to-moderate ulcerative colitis (UC). Despite the outcome, the treatment was well tolerated, with no reports of treatment-related serious adverse events, reinforcing the safety of Vedanta’s microbiome consortia platform.

COLLECTiVE202 enrolled 114 UC patients across the U.S., Europe, and Australia, testing VE202 as an add-on to stable background therapy. Although endoscopic response rates did not differ significantly from placebo, the company emphasized the study’s value in advancing scientific understanding of the microbiome’s role in inflammatory bowel disease (IBD).

“We’re disappointed VE202 did not achieve its efficacy goals, but we remain committed to unlocking the potential of microbiome-based treatments for IBD,” said Dr. Bernat Olle, CEO of Vedanta Biosciences. “The gut microbiome remains a largely untapped avenue in this disease area, and every well-executed study brings us closer to meaningful breakthroughs. We look forward to sharing deeper insights from COLLECTiVE202 at upcoming scientific meetings.”

Strategic Focus Remains on VE303

With the VE202 trial now complete, Vedanta is sharpening its focus on its lead program, VE303, currently in a global Phase 3 registrational trial (RESTORATiVE303) for the prevention of recurrent Clostridioides difficile infection (rCDI). Backed by robust Phase 2 data, VE303 has demonstrated best-in-class potential, achieving a 30.5% absolute risk reduction in recurrence and over 80% reduction in the odds of a CDI recurrence compared to placebo.

“Our priority now is executing on the promise of VE303, which has the potential to become the first FDA-approved Live Biotherapeutic Product,” said Dr. Olle. “There is a significant unmet need in recurrent C. difficile, and our platform is uniquely positioned to deliver a durable, defined, and scalable therapeutic solution.”

Pipeline Progress Continues

Vedanta is also advancing VE707, a preclinical program designed to prevent infections caused by multidrug-resistant organisms (MDROs) in vulnerable populations such as oncology and transplant patients. An IND filing is planned for the first half of 2026.

Despite the VE202 result, Vedanta remains a leader in the development of defined bacterial consortia therapeutics, supported by one of the industry’s most advanced product engines, including proprietary bacterial libraries, scalable manufacturing infrastructure, and deep expertise in consortium design.

Detailed analyses from COLLECTiVE202, including immunological, histological, and colonization findings, will be presented at scientific conferences later this year.