Phase II Study of VE 202 in ulcerative colitis did not meet primary endpoint- Vedanta Biosciences

Vedanta Biosciences announced that its candidate VE202 did not meet the primary endpoint of endoscopic response in the Phase II COLLECTiVE202 study for the treatment of patients with mild-to-moderate ulcerative colitis (UC). COLLECTiVE202 is a double-blind, placebo-controlled, randomized clinical trial  (NCT05370885) conducted at sites in the United States, Europe, and Australia. The study enrolled 114 patients, between the ages of 18 and 75 years, with mild-to-moderate ulcerative colitis who had not been exposed to any biologic or advanced oral therapies. Either VE202 (N=57) or placebo (N=57) was added to a patient’s stable background ulcerative colitis therapy. The primary endpoints were safety and Week 8 endoscopic response (defined as a reduction of at least 1 point on the Mayo endoscopic subscore). Secondary endpoints included clinical response and remission, endoscopic improvement and remission, as well as histological assessments and measures of colonization, quality-of-life and inflammatory biomarkers. 

In the randomized, placebo-controlled COLLECTiVE202 study, endoscopic and clinical responses were assessed using standardized criteria, and the observed response rates in the VE 202 group were not statistically different from those in the placebo group. VE202 was generally safe and well tolerated — most adverse events were mild or moderate in intensity, with no reports of treatment-related serious adverse events. Analyses of bacterial colonization, histological findings, and immune responses are ongoing and will be shared in future scientific forums.