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Lilly’s ulcerative colitis treatment meets all key endpoints in Phase III trial

pharmafile | March 17, 2021 | News story | Research and Development Eli Lilly, Phase III trial, lilly, mirikizumab, ulcerative colitis 

Eli Lilly’s mirikizumab treatment for ulcerative colitis (UC) patients has met the primary endpoints and all key secondary endpoints in a Phase III trial.

In the double-blind LUCENT-1 trial, mirikizumab was shown to achieve clinical remission in patients versus those given a placebo. Remission in this case was met when inflammation of the colon was controlled or resolved.

The study was also the first of its kind to demonstrate the ability of an anti-IL-23p19 monoclonal antibody to reduce bowel urgency in participants with moderate to severe UC.

The medicine was able to demonstrate improvement in patients four weeks after initiating treatment, and was able to reduce symptoms in participants who had failed to respond to previous therapies.

A further double-blind, placebo-controlled maintenance study, LUCENT-2, is continuing to monitor the effect of mirikizumab in patients who have completed the 12-week LUCENT-1 induction study.

UC is a chronic inflammatory disease of the large intestine, also referred to as the colon, that affects the lining of the colon and may cause ulcers to form. This inflammation can cause abdominal pain, bloody stools, incontinence, and frequent and urgent trips to the bathroom.

Dr Lotus Mallbris PhD, Vice President of Immunology Development at Lilly, said: ”People living with UC often struggle to effectively manage recurring flare ups of the disease. 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 UC.”

Dr Caren Heller, Chief Scientific Officer for the Crohn’s & Colitis Foundation, added: ”Ulcerative colitis can be debilitating and unpredictable for the hundreds of thousands of people living with this chronic disease. We’re encouraged by these promising results for a potential new treatment that may help provide symptom relief and remission.”

Jack Goddard

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