The company plans to initiate Phase III trials to assess mirikizumab’s benefit-risk profile to cure Crohn’s disease.

U.S. pharma giant, Eli Lilly and Co. has recently announced positive data from the Serenity Phase II study that evaluated the efficacy and safety of mirikizumab in patients with moderately to severely active Crohn’s disease.

According to the drug maker, patients treated with investigational antibody mirikizumab achieved reductions in clinical and endoscopic measures of disease activity after 12 weeks compared to placebo. Meanwhile, the maintenance phase of this study is currently ongoing.

Reportedly, in the study, patients with moderately- to severely active Crohn’s disease were randomized to receive either placebo or one of three doses of mirikizumab, which, for the record, is a trial-based antibody that targets the p19 subunit of interleukin 23.

The trial’s primary endpoint assessed mirikizumab against placebo on endoscopic response, which was identified as a 50% reduction from baseline in the severity of individual patient’s disease. Meanwhile, secondary endpoints contained clinical remission as measured by PRO (Patient Reported Outcomes) remission, endoscopic remission, and safety.

Speaking on the results, Lotus Mallbris, Vice-President, Immunology Development, Eli Lilly and Co., said that the company, following its last year’s presentation of positive Phase II results for mirikizumab for the treatment of moderate to severe ulcerative colitis, is delighted to return to DDW to display more positive data for mirikizumab in patients with chronic, inflammatory gastrointestinal diseases.

She said that their firm, while continuing to advance the science of gastroenterology, is hopeful that mirikizumab will help to raise the standard and make remission conceivable for patients living with immune-mediated illnesses like Crohn’s disease.

Reliable reports claim that Elli Lilly is planning to initiate Phase III trials to assess mirikizumab’s benefit-risk profile to cure Crohn’s disease. Whereas mirikizumab, which binds to the p19 subunit of interleukin 23, is being studied for the treatment of immune diseases, including ulcerative colitis, psoriasis, and Crohn’s disease.

Source Credit: https://www.drugdevelopment-technology.com/news/lilly-reports-positive-data-from-phase-ii-study-of-mirikizumab/

https://pharmaceutical-business-review.com/news/lillys-mirikizumab-succeeds-in-phase-2-study-in-crohns-disease/