Mirikizumab shows continued promise for ulcerative colitis after regulatory hiccup

Lilly has announced that its interleukin-23 blocker mirikizumab demonstrated promise in patients with moderately to severely active ulcerative colitis (UC) in the ongoing open-label LUCENT-3 extension study. The trial evaluated two-year efficacy and safety of the monoclonal antibody in patients who had previously undergone UC treatments, including biologics, that were ineffective, stopped working, or were intolerable.

In April, the company announced that it had received a complete response letter for mirikizumab for UC as a result of issues FDA identified related to the proposed manufacturing of the antibody. The agency noted no concerns about the clinical data package, safety, or label for the therapy.

After revealing the most recent LUCENT-3 data, Lilly plans on filing a marketing application for mirikizumab in Crohn’s disease to FDA. It intends to file paperwork with other regulatory agencies in 2024.  

Mirikizumab efficacy in LUCENT-3


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Lilly’s mirikizumab beats placebo in pivotal ulcerative colitis trial

Eli Lilly and Company (NYSE:LLY) announced that its interleukin-23 subunit p19 inhibitor mirikizumab achieved its primary endpoint of clinical remission at 52 weeks in the Phase 3 LUCENT-2 study.

Lilly says mirikizumab is the first anti-IL23p19 to demonstrate maintenance of clinical remission in a Phase 3 ulcerative colitis study.

Janssen (NYSE:JNJ) has ongoing clinical trials testing its interleukin-23 subunit p19 inhibitor guselkumab (Tremfya) as an inflammatory bowel disease therapy. Studies are ongoing testing guselkumab for adults with moderately to severely active ulcerative colitis.

Participants in Lilly’s LUCENT-2 study were previously enrolled in a 12-week induction study known as LUCENT-1.

Subjects in LUCENT-2 were rerandomized to receive mirikizumab maintenance dosing.

Lilly notes that a statistically higher number of mirikizumab recipients achieved clinical remission at one year than placebo recipients.

“Bowel urgen…

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