Pfizer and Eli Lilly Report Positive Phase 3 Results for Ulcerative Colitis Therapies

Ulcerative colitis is a chronic, systemic, inflammatory disease caused by inflammation of the large intestine, which triggers abdominal pain, bloody diarrhea, severe urgency to defecate, weight loss, and fatigue. The severity of symptoms and the uncertainty of disease recurrence place a heavy burden on patients and often lead to disability. Several biopharmaceutical companies are developing innovative therapies for ulcerative colitis. Today, Pfizer and Eli Lilly and Company respectively announced the results of Phase 3 clinical trials for their respective investigational treatments.

50% of Patients Achieved Clinical Remission After 1 Year, Eli Lilly's IL-23 Inhibitor Demonstrates Long-Term Efficacy

Eli Lilly and Company announced that its monoclonal antibody mirikizumab, targeting the p19 subunit of IL-23, achieved positive results in a Phase 3 clinical trial. Among patients who responded after 12 weeks of mirikizumab treatment, approximately half (49.9%) of those receiving mirikizumab maintenance therapy achieved clinical remission one year later, compared to 25.1% in the placebo group.

Almost all (97.8%) patients treated with mirikizumab who achieved clinical remission after 1 year had been free of corticosteroids for at least 3 months. Mirikizumab also significantly improved patients' urgency of bowel movements.

Eli Lilly and Company has submitted regulatory applications to the U.S. FDA and the European EMA for the use of mirikizumab in treating ulcerative colitis, with responses expected in 2023.

Pfizer's S1P Receptor Modulator Shows "Best-in-Class" Potential

Pfizer Announces Detailed Results of Two Phase 3 Clinical Trials for Etrasimod, a Selective Sphingosine-1-Phosphate (S1P) Receptor ModulatorPfizer Inc. today announced detailed results from two Phase 3 clinical trials of etrasimod, a selective sphingosine-1-phosphate (S1P) receptor modulator. Both trials met their primary and key secondary endpoints. In the 52-week ELEVATE UC 52 study, 32.1% of patients in the etrasimod group achieved clinical remission at week 52, compared to 6.7% in the placebo group (p<0.001). In the 12-week ELEVATE UC 12 trial, 24.8% of patients in the etrasimod group achieved clinical remission, compared to 15.2% in the placebo group (p=0.0264).

Etrasimod was developed by Arena Pharmaceuticals, which Pfizer acquired in March this year. Etrasimod is a next-generation oral S1P modulator that specifically binds to S1P receptors 1, 4, and 5, potentially offering better efficacy and safety profiles. Notably, Everest Medicines holds the development rights for etrasimod in Greater China.

Michael Corbo, Chief Development Officer of Pfizer's Inflammation and Immunology division, stated: "Patients with ulcerative colitis often need multiple options to manage their condition, and there is a significant demand for new therapies. Etrasimod has demonstrated encouraging efficacy and safety, and we believe that if approved, it will have a meaningful impact on both patients and physicians."

References:

[1] Fifty Percent of Patients with Ulcerative Colitis Treated with Mirikizumab Achieved Clinical Remission at One Year in Lilly's Pivotal Phase 3 Study. Retrieved May 24, 2022, from https://www.prnewswire.com/news-releases/fifty-percent-of-patients-with-ulcerative-colitis-treated-with-mirikizumab-achieved-clinical-remission-at-one-year-in-lillys-pivotal-phase-3-study-301552268.html

[2] Pfizer Presents ELEVATE Pivotal Findings Demonstrating Etrasimod’s Potentially Best-in-Class Profile in Ulcerative Colitis. Retrieved May 24, 2022, from https://www.businesswire.com/news/home/20220524005178/en

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