Lilly's mirikizumab hits main goal of induction study for ulcerative colitis

Eli Lilly said Tuesday that mirikizumab led to significantly higher clinical remission rates than placebo among patients with moderate-to-severe ulcerative colitis in the Phase III LUCENT-1 study. The trial also achieved all key secondary endpoints, with Eli Lilly noting that LUCENT-1 is the first late-stage study of an anti-IL-23p19 monoclonal antibody to demonstrate reduced bowel urgency in this indication.

The 12-week induction study was designed to evaluate intravenous mirikizumab versus placebo in 1160 patients with moderate-to-severe ulcerative colitis who have failed conventional and/or biologic treatments. The primary endpoint is clinical remission at week 12, while key secondary goals include reduced bowel urgency, clinical response, endoscopic remission, symptomatic remission and improvement in endoscopic histologic inflammation.

Eli Lilly said symptom improvement was observed as early as four weeks after starting treatment, while mirikizumab also relieved symptoms among patients who had previously not responded to or stopped responding to biologic and/or JAK inhibitor therapies. Meanwhile, the rate of treatment-emergent adverse events (AEs) and serious AEs among patients given mirikizumab was comparable to the previous Phase II trial of the drug in ulcerative colitis and to studies with the anti-IL-23p19 antibody class, according to the company. The most common AEs for both arms of the trial included nasopharyngitis, anaemia and headache.

LUCENT-2 maintenance study ongoing

"With these positive results, we look forward to the continuation of the maintenance study through 52 weeks in hopes of providing a new option to people living with ulcerative colitis," remarked Lotus Mallbris, vice president of immunology development at Eli Lilly. The ongoing LUCENT-2 study is investigating mirikizumab as maintenance treatment in patients who have completed LUCENT-1.

Full results from the induction and maintenance studies are anticipated in early 2022. These will be disclosed at a future conference or publication, along with results from the LUCENT-3 open-label extension trial, the company said.

Mirikizumab, also known as LY3074828, is being evaluated as a potential treatment for other immune diseases as well, including psoriasis and Crohn's disease. Last year, the drug demonstrated superiority to Novartis' Cosentyx (secukinumab) in the Phase III OASIS-2 study of patients with moderate-to-severe plaque psoriasis.

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