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CAMBRIDGE - Vedanta Biosciences announced Wednesday that its experimental treatment VE202 for mild-to-moderate ulcerative colitis failed to meet the primary endpoint in a Phase 2 clinical trial.
The study, known as COLLECTiVE202, showed that endoscopic and clinical response rates in patients receiving VE202 were not statistically different from those in the placebo group. The microbiome-based oral therapy was generally well-tolerated with no treatment-related serious adverse events reported.
Following these disappointing results, Vedanta will shift its focus to its lead program VE303, which is currently in a global Phase 3 trial for the prevention of recurrent Clostridioides difficile infection. The company noted that ulcerative colitis and C. difficile are distinct diseases with different underlying biology, and the two drug candidates have different bacterial compositions and mechanisms of action.
"We are very disappointed that our study did not meet its efficacy endpoints," said Bernat Olle, CEO of Vedanta Biosciences, in a press release statement. He added that the company remains committed to sharing further analyses from the study at upcoming scientific meetings.
The Phase 2 trial enrolled 114 patients across sites in the United States, Europe, and Australia. Participants were between 18 and 75 years old with mild-to-moderate ulcerative colitis who had not been exposed to biologic or advanced oral therapies.
Vedanta is also advancing VE707, designed to prevent infections caused by multidrug-resistant organisms, with an investigational new drug submission planned for the first half of 2026.
PureTech Health plc (NASDAQ:PRTC, LSE:PRTC), which founded Vedanta, noted that its ownership stake in the company has been diluted to 4.2% on a fully diluted basis over the course of 2025.
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