Vedanta Biosciences’ dreams of using live bacteria to treat inflammatory bowel disease (IBD) have been dashed. The Massachusetts-based microbiome outfit’s mixture of 16 bacterial strains failed to reduce disease severity in the colons of patients with ulcerative colitis.
The phase 2 Collective202 trial enrolled 114 patients with mild to moderate ulcerative colitis and compared Vedanta’s bacterial cocktail VE202 with placebo. While VE202 led to no treatment-related adverse events, the company said in an Aug. 13 release, it did not beat placebo at improving disease symptoms, as assessed using an endoscope.
“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,” Vedanta CEO Bernat Olle, Ph.D., said in the release. “As a field, we have not yet succeeded in making a meaningful impact for people with IBD through microbiome-based approaches, but every study moves us closer to that goal.”
Vedanta plans to share further data from the phase 2 trial at upcoming conferences, according to the release.
In response to the fail, Vedanta is reorienting resources toward lead candidate VE303, which is chasing the tail of Seres Therapeutics’ Vowst in treating recurrent infections caused by the bacteria Clostridioides difficile. Vowst became the first FDA-approved oral microbiome therapy in April 2023. Vedanta is currently enrolling patients in a registrational phase 3 trial for VE303, with an anticipated primary completion date in June 2027.
As part of this shift, the company is laying off 20% of its staff, Olle said in an Aug. 13 LinkedIn post.
Bacterial mixtures like Vedanta’s aim to reset out-of-whack gut microbiomes by enlisting healthy bacteria to evict and replace others that may be causing disease. VE202 was designed to use 16 strains of living bacterial cells to drive out Enterobacteriaceae, which the company says is a driver of inflammation in IBD.
Seres’ landmark approval sparked a fire in Vedanta’s investors, who in 2023 showered the company with a $107 million series C to try to replicate Vowst’s success. Vedanta’s approach to cultivating bacteria is different from Seres' Vowst and former rival Finch Therapeutics, as it depends on fermentation vats rather than growing microbes sourced from donor stool.
About a year after that fundraise, a dip in manufacturing needs prompted Vedanta to lay off 24 employees.
With VE202 on the back burner, VE303 is now Vedanta’s sole clinical focus. Another prospect designed to prevent antibiotic-resistant infections in high-risk patients, VE707, is still in the preclinical stage. The biotech plans to submit an investigational new drug application for the asset in the first half of 2026, Vedanta said in the release.
Editor's note: This story was updated at 4:30 p.m. ET to add information about layoffs being conducted by Vedanta.