Vedanta Biosciences Faces Setback in Microbiome Therapy for Ulcerative Colitis

Vedanta Biosciences, a pioneer in microbiome drug research, has announced disappointing results from a Phase 2 clinical trial of its experimental therapy VE202 for mild-to-moderate ulcerative colitis. The setback has led to a significant workforce reduction and a strategic shift in the company's focus.

Clinical Trial Failure and Company Restructuring

The Phase 2 study revealed that VE202 failed to meet its primary endpoint, showing no significant improvement over placebo in patients' endoscopic exams after eight weeks of treatment. This outcome represents another stumbling block in the pursuit of microbiome-based therapies for inflammatory bowel disease (IBD), an area that has long been a priority for companies in this field.

In response to the trial's failure, Vedanta has announced a layoff of approximately 20% of its staff. CEO and co-founder Bernat Olle addressed the setback, stating, "Drug development rarely follows a straight path. 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 setback, Vedanta is reallocating its resources to concentrate on two key areas:

1. A Phase 3 clinical trial for VE303, a therapy targeting recurrent Clostridioides difficile (C. diff) infections.
2. Preclinical development of a therapy designed to prevent infections from antibiotic-resistant bacteria.

The company's approach to C. diff infections with VE303 represents what Vedanta calls a "next-generation approach" to microbiome therapy. Unlike Seres Therapeutics' Vowst, which uses donor stool samples, VE303 is composed of eight specific bacterial strains produced from cell banks, eliminating the need for donor samples of "inconsistent composition."

Industry Context and Future Outlook

Vedanta's experience underscores the ongoing challenges in microbiome research, particularly in the realm of IBD treatment. The field has seen similar setbacks, including Seres Therapeutics' failure in a mid-stage IBD trial in 2021. Despite these obstacles, Vedanta remains committed to advancing microbiome science, with Olle emphasizing the company's dedication to sharing further analyses from the study to "help chart new paths forward."

Founded in 2010 by PureTech, Vedanta has raised over $300 million in funding, including a $106.5 million Series C round in 2023. The company's strategic pivot and continued pursuit of microbiome-based therapies reflect the persistent interest in this field, despite the hurdles encountered in clinical development.