Vedanta Biosciences Faces Setback in Microbiome Therapy Development

Vedanta Biosciences, a pioneering microbiome startup, has announced a significant restructuring following disappointing clinical trial results for its ulcerative colitis treatment. The company, backed by PureTech Health, is now pivoting its focus to other areas of microbiome research while reducing its workforce.

Clinical Trial Failure and Workforce Reduction

Vedanta's experimental therapy VE202 failed to meet its primary endpoint in a Phase 2 study for mild-to-moderate ulcerative colitis. The treatment did not show significant improvement over placebo in endoscopic examinations after eight weeks of treatment. In response to this setback, Vedanta CEO and co-founder Bernat Olle announced a 20% reduction in the company's workforce.

"Drug development rarely follows a straight path," Olle stated on LinkedIn. "You can do the right science, run the right study, and still be humbled by the complexities of human biology."

Shift in Research Focus

Following this development, Vedanta is reallocating its resources to focus on two key areas:

1. A Phase 3 drug candidate for preventing recurrent Clostridioides difficile (C. diff) infections
2. A preclinical therapy aimed at preventing infections from antibiotic-resistant bacteria

The company's C. diff treatment, VE303, is currently enrolling patients in a Phase 3 study with a primary completion date set for 2027. Unlike some competitor products, VE303 uses a defined consortium of eight specific bacterial strains produced from cell banks, which Vedanta describes as a "next-generation approach" to microbiome therapy.

Microbiome Research Challenges

Vedanta's setback highlights the ongoing challenges in microbiome drug development, particularly in the field of inflammatory bowel disease (IBD). Despite being a prime target for microbiome research due to the role of intestinal bacteria in these conditions, success has remained elusive. Seres Therapeutics, another leader in the field, faced a similar failure in 2021 with its IBD treatment.

"As a field, we have not yet succeeded in making meaningful impact in people with IBD through microbiome-based approaches," Olle acknowledged. "But every study moves us closer to that goal."

Despite these challenges, the microbiome field has seen some success. In 2023, Seres Therapeutics brought to market Vowst, a drug for preventing recurrent C. diff infections. Vedanta's VE303 aims to improve upon this approach by eliminating the need for donor stool samples and providing a more consistent composition.