Vedanta Biosciences, a microbiome-focused biotechnology company backed by PureTech Health, announced Wednesday it will lay off approximately 20% of its workforce following the failure of its experimental therapy VE202 in a Phase 2 ulcerative colitis trial. The setback represents another challenge for the microbiome therapeutics field, which has struggled to translate promising early research into effective treatments for inflammatory bowel disease.
Clinical Trial Results
VE202 failed to meet its primary endpoint in the Phase 2 study evaluating patients with mild-to-moderate ulcerative colitis. The experimental therapy was not significantly better than placebo at improving signs of patients' disease on an endoscopic examination after eight weeks of treatment, according to the company's announcement.
The drug, which Johnson & Johnson licensed in 2015, represents one of Vedanta's packaged bacteria strain therapies delivered in pill form. The company has been developing VE202 specifically for inflammatory bowel disease, capitalizing on research suggesting intestinal bacteria play a role in driving the condition.
Strategic Refocus
CEO and co-founder Bernat Olle revealed the workforce reduction in a LinkedIn post, acknowledging the unpredictable nature of drug development. "Drug development rarely follows a straight path," Olle wrote. "You can do the right science, run the right study, and still be humbled by the complexities of human biology."
Moving forward, Vedanta will concentrate resources on two key programs. The company's primary focus will be VE303, currently in Phase 3 testing for recurrent Clostridioides difficile infections. Additionally, Vedanta plans to advance a preclinical therapy designed to prevent infections from antibiotic-resistant bacteria, with human testing expected to begin in the first half of next year.
Industry Context
The VE202 failure adds to a growing list of setbacks in microbiome-based inflammatory bowel disease treatments. Seres Therapeutics, a field leader, experienced a similar mid-stage trial failure in 2021. "As a field, we have not yet succeeded in making meaningful impact in people with IBD through microbiome-based approaches," Olle acknowledged on LinkedIn.
Despite these challenges, Olle expressed continued commitment to the field, noting that "every study moves us closer to that goal." The company plans to share further analyses from the study at scientific meetings "to help chart new paths forward."
Pipeline Pivot
Vedanta's strategic shift toward C. diff infections aligns with an area where microbiome therapies have demonstrated more success. Seres brought Vowst to market in 2023 for preventing recurrent C. diff infections, derived from human donor stool samples.
VE303 represents what Vedanta calls a "next-generation approach" to microbiome therapy. Unlike Vowst, VE303 consists of a defined consortium of eight specific bacterial strains produced from cell banks, bypassing the need for donor samples of "inconsistent composition."
The company is currently enrolling patients in a Phase 3 study that began last year, with a primary completion date scheduled for 2027 according to federal databases.
Company Background
Founded by PureTech in 2010, Vedanta was among the first startups to explore the relationship between the human microbiome and disease. The company has raised more than $300 million in funding, including a $106.5 million Series C round in 2023, to develop medicines that package bacteria strains into pill form.
"Cracking the code of microbiome intervention in IBD remains as challenging — and as inspiring — as it was a decade ago when it first captured our attention," Olle reflected on the ongoing challenges facing the field.
