Lilly Reports 1-year Histologic Data From Phase 3 VIVID-1 Study Of Mirikizumab In Crohn's Disease

(RTTNews) - Eli Lilly and Company (LLY) Monday announced 1-year histologic data from the Phase 3 VIVID-1 study of mirikizumab in people with Crohn's disease, a type of inflammatory bowel disease.

Crohn's disease inflammation occurs at the cellular level, defined as histologic inflammation, and persists even after treatment with standard of care therapies in up to one-quarter of patients despite evidence of endoscopic mucosal healing, Lilly said.

The study evaluated the safety and efficacy of mirikizumab compared with placebo and ustekinumab in adults with moderately to severely active Crohn's disease. In this study, 49% of patients taking mirikizumab or placebo had experienced a prior biologic failure. VIVID-1 is the first Phase 3 study in Crohn's disease to report histologic and combined histologic-endoscopic outcomes that were evaluated using a systematic assessment of five bowel segments.

Data from the study showed that more patients with active Crohn's disease treated with mirikizumab achieved histologic response at Week 52 compared to ustekinumab, regardless of prior biologic experience. Mirikizumab achieved nominally statistically significant improvements across all histologic and histologic-endoscopic endpoints versus placebo at Weeks 12 and 52, and versus ustekinumab. Further, the overall safety profile of mirikizumab in Crohn's disease was consistent with the known safety profile in patients with ulcerative colitis (UC).

These results are being presented at United European Gastroenterology (UEG) Week, held in Vienna, Austria from October 12-15.

Mirikizumab is approved for UC and sold under the brand name Omvoh.

Lilly has submitted marketing authorization applications for mirikizumab in Crohn's disease in countries including the U.S., Europe, Japan and China.