Mirikizumab Demonstrates Superiority over Placebo in Phase 3 Maintenance Study in Ulcerative Colitis, Supporting Regulatory Submissions in 2022
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
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.
"Existing therapies aren't fully meeting the needs of people with ulcerative colitis who still have unresolved symptoms that impact their health and quality of life," said Lotus Mallbris, M.D., Ph.D., vice president of global immunology development and
With these data,
"The results announced today are encouraging for those who live with ulcerative colitis," said
Topline results from the Phase 3 induction study, LUCENT-1, were announced in
Mirikizumab is a humanized IgG4 monoclonal antibody that binds to the p19 subunit of interleukin 23. Mirikizumab is being studied for the treatment of immune-mediated diseases, including ulcerative colitis and Crohn's disease.
About the LUCENT Clinical Trial Program
The LUCENT Phase 3 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 3 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.
The program began in 2018, with full results from the induction and maintenance studies anticipated in early 2022.
About Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory bowel disease that affects the colon.1 UC occurs when the immune system sends white blood cells into the lining of the intestines, where they produce chronic inflammation and ulcerations.2 There is an unmet need for additional treatment options for UC that provide meaningful symptom relief, including bowel urgency, and deliver sustained clinical remission. UC can cause significant and debilitating disruptions in daily life. Millions of people live with UC globally.3
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This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about mirikizumab as a potential treatment for patients with ulcerative colitis and other diseases and reflects Lilly's current beliefs and expectations. As with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that mirikizumab will prove to be a safe and effective treatment or that mirikizumab will receive regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
1 Overview of Ulcerative Colitis. Crohn's and Colitis Foundation Website. https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis/overview. Accessed December 2021.
2 What is Ulcerative Colitis? Crohn's and Colitis Foundation Website. http://www.crohnscolitisfoundation.org/what-are-crohns-and-colitis/what-is-ulcerative-colitis/. Accessed December 2021.
3 Adelphi Data 2017.
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