Eli Lilly and Company has reported positive data from the Serenity Phase II study that evaluated the safety and efficacy of mirikizumab in patients with moderately to severely active Crohn's disease.
The company noted that patients treated with investigational antibody mirikizumab achieved significant reductions in clinical and endoscopic measures of disease activity after 12 weeks compared to placebo.
The maintenance phase of the multi-centre, randomised, parallel-arm, double-blind, placebo-controlled study is ongoing.
Subjects with Crohn's disease were randomised to receive either placebo or one of three doses of mirikizumab for the study.
At baseline, subjects were randomised with a 2:1:1:2 allocation across mirikizumab 200mg, 600mg, 1,000mg, and placebo treatment arms.
The trial’s primary endpoint evaluated mirikizumab versus placebo on endoscopic response, which was defined as a 50% reduction from baseline in the severity of each patient's disease.
Secondary endpoints of the trial included clinical remission as measured by patient-reported outcomes (PRO remission), endoscopic remission, and safety.
Eli Lilly and Company Immunology Development vice-president Lotus Mallbris said: “Following last year's presentation of positive Phase II results for mirikizumab for the treatment of moderate to severe ulcerative colitis, we are excited to return to DDW to present more positive data for mirikizumab in patients with chronic, inflammatory gastrointestinal conditions.
“As we continue to advance the science of gastroenterology, we are hopeful that mirikizumab helps us raise the standard and make remission possible for people living with immune-mediated diseases like Crohn's disease.”
The company also plans to initiate Phase III trials to evaluate mirikizumab's benefit-risk profile to treat Crohn's disease.
Mirikizumab, which binds to the p19 subunit of interleukin 23, is being studied for the treatment of immune diseases, including psoriasis, ulcerative colitis, and Crohn's disease.