Eli Lilly announces results from VIVID-2 study

Eli Lilly (LLY) announced results from the VIVID-2 open-label extension study, which showed the majority of patients with moderately to severely active Crohn’s disease receiving two years of continuous treatment with Omvoh achieved long-term clinical and endoscopic outcomes, including those with previous biologic failure. Data from this study will be presented at the Crohn’s and Colitis Congress, being held from February 6-8 in San Francisco. Omvoh works to reduce inflammation within the gastrointestinal tract by targeting a specific protein, interleukin-23p19, which is a key contributor to intestinal inflammation. Participants randomized to Omvoh in the Phase 3 VIVID-1 study who achieved endoscopic response after one year of treatment continued Omvoh maintenance treatment in VIVID-2. The following results were achieved based upon observed case analysis after two years of continuous treatment, including one year during VIVID-1: Among patients who were in clinical remission at one year in VIVID-1, 92.9% maintained clinical remission at two years as measured by Crohn’s Disease Activity Index. Among patients treated in VIVID-2, 87.6% maintained endoscopic response, defined by visible healing of the intestinal lining and measured by a 50% reduction from baseline in Simple Endoscopic Score for Crohn’s Disease total score. Among patients who were in endoscopic remission at one year of treatment in VIVID-1, 78.6% maintained endoscopic remission at two years as measured by SES-CD 4 and 2-point reduction from baseline, with no subscore greater than 1 in any individual variable. Among patients who were not in clinical remission by CDAI at one year, 60.8% gained clinical remission during the second year of treatment. Among patients who were not in endoscopic remission at one year, 35.4% gained endoscopic remission during the second year of treatment. These results were also evaluated using a modified non-responder imputation method, presented in the About the VIVID Clinical Trial Program section below. In VIVID-2, the long-term safety profile of Omvoh in patients with moderately to severely active Crohn’s disease was generally consistent with the known safety profile of Omvoh. During the second year of continuous treatment with Omvoh, 6.8% of patients with endoscopic response at one year reported a serious adverse event and 0.8% discontinued treatment due to an adverse event.