Policy & Regulation
Eli Lilly and Company introduces new safety and efficacy data for mirikizumab
23 May 2019 -

United States-based Eli Lilly and Company (NYSE: LLY) has announced new safety and efficacy data for mirikizumab in patients with moderately- to severely active Crohn's disease.

It was reported yesterday that Patients treated with mirikizumab in the SERENITY Phase two study achieved significant decrease in clinical and endoscopic measures of disease activity at 12 weeks compared to placebo. The maintenance phase of this study is ongoing.

In this study, patients with moderately- to severely active Crohn's disease were randomised to receive either placebo or one of three doses of mirikizumab, which is an investigational antibody that targets the p19 subunit of interleukin 23. The primary endpoint evaluated mirikizumab versus placebo on endoscopic response, which was defined as a 50% decrease from baseline in the severity of each patient's disease, as measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD)1. Secondary endpoints included clinical remission as measured by Patient Reported Outcomes (PRO remission), endoscopic remission, and safety.

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