Vedanta Biosciences has announced that VE202 failed to meet the primary endpoint in its phase 2 COLLECTiVE202 study for mild-to-moderate ulcerative colitis.
The trial assessed endoscopic response at Week 8, but results showed no statistically significant difference between VE202 and placebo. Clinical and histological endpoints also did not demonstrate meaningful efficacy.
Despite the outcome, VE202 was well tolerated. Most adverse events were mild or moderate, with no reports of treatment-related serious adverse events. Further analyses on bacterial colonisation and immune response will be presented at upcoming scientific meetings.
Bernat Olle, chief executive officer of Vedanta Biosciences, said: “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.”
He added: “Our priority at Vedanta remains the successful execution of our ongoing global pivotal study of VE303 for the prevention of recurrent C. difficile infection, with the goal of potentially delivering the first approved Live Biotherapeutic Product in any indication.”
The company is now focusing on RESTORATiVE303, a phase 3 registrational study of VE303 in recurrent C. difficile infection. The trial is enrolling patients at over 200 sites across 24 countries.
VE303 previously showed strong efficacy in phase 2, with a 30.5% absolute risk reduction and over 80% reduction in the odds of recurrence compared to placebo.
Vedanta is also progressing VE707, aimed at preventing infections caused by multidrug-resistant organisms in vulnerable populations. An IND submission is planned for the first half of 2026.
