Mirikizumab demonstrates superiority over placebo in phase III maintenance study in ulcerative colitis.

Patients in this study were previously enrolled in a 12-week induction study, LUCENT-1. These results build on the positive outcomes from LUCENT-1.

In LUCENT-2, for patients who achieved clinical response with mirikizumab in the 12-week induction study and were re-randomized to mirikizumab maintenance dosing, a statistically higher proportion met the primary endpoint of clinical remission at one year compared to patients who were re-randomized to placebo (p<0.001). clinical remission is reached when inflammation of the colon is controlled or resolved, leading to normalization or near-normalization of symptoms such as frequent and bloody stools. all key secondary endpoints were also met (p><0.001), including significantly higher proportions of patients treated with mirikizumab achieving endoscopic remission, corticosteroid-free remission, resolution or near-resolution of bowel urgency, improvement in endoscopic histologic intestinal inflammation and maintenance of remission, and greater reduction from baseline in bowel urgency symptoms at one year compared to placebo.

"In this maintenance study, treatment with mirikizumab demonstrated clinically meaningful and statistically significant improvements in clinical, endoscopic and histologic measures, including reduction of bowel urgency – a novel endpoint in the LUCENT program," said Bruce E. Sands, M.D., M.S., Dr. Burrill B. Crohn Professor of Medicine, Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai. "Bowel urgency is one of the most bothersome and disruptive symptoms people living with ulcerative colitis experience, and the LUCENT program leveraged an innovative and systematic patient-centric approach to assess patients' symptoms."

In the placebo-controlled maintenance cohort, the frequency of serious adverse events among patients treated with mirikizumab was numerically lower compared to placebo, and the overall safety profile was consistent with that of the previous mirikizumab studies in UC and other studies within the anti-IL-23p19 antibody class.

The most common treatment emergent adverse events reported among patients treated with mirikizumab were nasopharyngitis, arthralgia and exacerbation of ulcerative colitis. Additional adverse events of interest reported among patients treated with mirikizumab included hypersensitivity, injection site reaction, depression, liver enzyme elevation, herpes zoster and oral candidiasis.

With these data, Lilly plans to submit a Biologics License Application (BLA) to the FDA for mirikizumab in UC, followed by submissions to other regulatory agencies around the world in the first half of 2022.

Topline results from the Phase III induction study, LUCENT-1, were announced in March 2021. Data from the Phase III LUCENT program, including results from LUCENT-1 and LUCENT-2, will be disclosed at upcoming congresses and in publications in 2022. Additional Phase III clinical trials are ongoing for mirikizumab in Crohn's disease.

About the LUCENT Clinical Trial Program : The LUCENT Phase III clinical development program for mirikizumab includes LUCENT-1, LUCENT-2 and LUCENT-3. LUCENT-1 (NCT03518086) is a multicenter, randomized, double-blind, placebo-controlled induction study of mirikizumab in patients with moderately-to-severely active ulcerative colitis who have previously failed conventional and/or biologic therapies and/or JAK inhibitors. LUCENT-2 (NCT03524092) is a multicenter, randomized, double-blind, placebo-controlled, Phase III maintenance study in patients who completed LUCENT-1. LUCENT-3 (NCT03519945) is an open label extension study for eligible patients who have participated in mirikizumab UC trials.