Vedanta's Bacterial Cocktail for Ulcerative Colitis Fails in Phase 2 Trial, Company Shifts Focus

Vedanta Biosciences, a Massachusetts-based microbiome company, has announced that its live bacterial cocktail VE202 failed to meet efficacy endpoints in a phase 2 trial for ulcerative colitis. The news marks a significant setback for the company's inflammatory bowel disease (IBD) program and has prompted a strategic shift towards other pipeline candidates.

Trial Results and Company Response

The phase 2 Collective202 trial, which enrolled 114 patients with mild to moderate ulcerative colitis, compared VE202 to placebo. Despite showing no treatment-related adverse events, the bacterial mixture did not demonstrate superiority over placebo in reducing disease severity, as assessed by endoscopic evaluation.

"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 Vedanta CEO Bernat Olle, Ph.D., in a company release.

In response to the trial failure, Vedanta is implementing significant changes:

1. Reallocation of resources towards lead candidate VE303 for recurrent Clostridioides difficile infections
2. Layoff of 20% of its staff, as announced by CEO Olle in a LinkedIn post
3. Plans to share further data from the phase 2 trial at upcoming conferences

Strategic Pivot and Pipeline Focus

Vedanta is now concentrating its efforts on VE303, which is currently in a registrational phase 3 trial with an anticipated primary completion date in June 2027. This candidate aims to compete with Seres Therapeutics' Vowst, which became the first FDA-approved oral microbiome therapy in April 2023.

The company's approach differs from competitors like Seres and Finch Therapeutics, as Vedanta utilizes fermentation vats rather than donor stool-sourced microbes for bacterial cultivation.

Additionally, Vedanta continues to develop VE707, a preclinical candidate designed to prevent antibiotic-resistant infections in high-risk patients. The company plans to submit an investigational new drug application for VE707 in the first half of 2026.