In two randomized, double-blind, placebo-controlled clinical trials, the safety and effectiveness of OMVOH were assessed.
The first study (UC-1, NCT03518086) focused on inducing remission, while the second study (UC-2, NCT03524092) aimed at maintaining remission in adults with moderately to severely active ulcerative colitis who did not respond adequately to or could not tolerate corticosteroids, 6-mercaptopurine, azathioprine, biologic therapies (such as TNF blockers, vedolizumab), or tofacitinib.
Bowel Urgency: During both UC-1 and UC-2, the urgency of bowel movements was evaluated using a numerical rating scale (NRS) ranging from 0 to 10.
OMVOH treatment demonstrated a higher proportion of patients with a baseline weekly average NRS score of ≥3 achieving a weekly average score of 0 or 1 at Week 40 compared to the placebo group (39% versus 23%). This favorable outcome was also observed at Week 12.
Endoscopic Assessment:
Endoscopic remission, defined as a Mayo endoscopic subscore of 0, indicated the normalization of the mucosal appearance.
In UC-2 at Week 40, a greater percentage of patients receiving OMVOH achieved endoscopic remission compared to those on placebo (22% versus 14%).