Lilly's IL-23 Inhibitor Mirikizumab Achieves Phase 3 Trial Endpoints with 75% of Patients Showing Near-Complete Psoriasis Clearance

Eli Lilly and Company recently announced that mirikizumab, an IL-23 monoclonal antibody developed by the company, met the primary and all key secondary endpoints versus placebo at Weeks 16 and 52, as well as all key secondary endpoints versus the active comparator, in the Phase 3 OASIS-2 clinical trial. OASIS-2 is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of mirikizumab compared with placebo and an active comparator in patients with moderate-to-severe plaque psoriasis.

Psoriasis, also known as "niupixuan," is a common chronic, autoimmune inflammatory skin disease. Psoriasis affects approximately 125 million people worldwide, of whom about 20% have moderate-to-severe plaque psoriasis. Although symptoms vary among patients, they may include red patches covered with silvery scales, dryness, cracking, bleeding, and thickened, pitted, or raised nails. For patients with more severe symptoms, psoriasis significantly impacts their quality of life.

Mirikizumab is a humanized IgG4 monoclonal antibody that binds to the p19 subunit of IL-23, thereby blocking IL-23-mediated inflammatory responses. Mirikizumab is currently being evaluated in multiple clinical trials for the treatment of immune-mediated diseases, including psoriasis, ulcerative colitis, and Crohn's disease.

In the OASIS-2 trial, the primary endpoints were the proportion of patients with a static Physician’s Global Assessment (sPGA) score of 0 or 1 and an improvement of at least 2 points from baseline, as well as the proportion of patients achieving at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) from baseline, both assessed at Week 16 post-treatment compared with placebo. Comparisons with the active control group at Week 16 constituted key secondary endpoints. The trial results demonstrated that mirikizumab met both the primary and key secondary endpoints. At 16 weeks of treatment, the proportions of patients achieving sPGA (0,1) and PASI 90 were 79.7% and 74.4%, respectively, showing significant superiority over the placebo group. Please refer to the table below for detailed data.

▲Efficacy data of mirikizumab in OASIS-2 (Image source: Reference [1])

“These study results bring hope to psoriasis patients around the world,” said Patrik Jonsson, President of Eli Lilly Biopharmaceuticals. “We look forward to bringing mirikizumab to market, providing patients with a new treatment option. The PASI 90 and PASI 100 outcomes indicate that it has the potential to deliver near-complete or complete clearance of skin symptoms, demonstrating durable efficacy at 52 weeks.”

References:

[1] Lilly's Mirikizumab Superior to Cosentyx® (secukinumab) in a Phase 3 Study for Patients with Moderate to Severe Plaque Psoriasis. Retrieved July 17, 2020, fromhttps://investor.lilly.com/news-releases/news-release-details/lillys-mirikizumab-superior-cosentyxr-secukinumab-phase-3-study

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