Eli Lilly’s Mirikizumab Hits the Mark in Phase III Study, Bests Cosentyx

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Eli Lillys experimental treatment for plaque psoriasis beat out Novartis’ vaunted drug Cosentyx in a comparison study. Mirikizumab met all primary endpoints against placebo and secondary endpoints against Cosentyx in the Phase III study, the Indianapolis-based pharma company announced.

With the positive data in hand from the OASIS-2 studies, Eli Lilly plans to seek regulatory approval for mirikizumab, an investigational monoclonal antibody that binds to the p19-subunit of IL23, as a treatment for patients with moderate to severe plaque psoriasis. In the studies, mirikizumab demonstrated superiority to placebo and non-inferiority to Cosentyx at week 16. By week 52, mirikizumab demonstrated superiority to Cosentyx, Eli Lilly said. The safety profile for mirikizumab remained consistent with previous studies, the company noted.

Psoriasis affects approximately 125 million people worldwide, approximately 20% of whom have moderate to severe plaque psoriasis.

In OASIS-2, the primary endpoints were the proportion of patients with a Static Physician's Global Assessment (sPGA) of (0,1) with at least a 2-point improvement and the proportion of patients with at least a 90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90) at Week 16 compared to placebo. Key secondary endpoints at Week 52 compared to Cosentyx included the proportion of patients with a sPGA of (0,1) with at least a 2-point improvement and the proportion of patients with at least a 90 and 100% improvement from baseline in PASI 90/PASI 100. Full study results from OASIS-2 will be presented at a future medical conference.

Patrik Johnsson, president of Lilly Bio-Medicines, said the results of the OASIS study are promising as a potential therapeutic for patients suffering from plaque psoriasis, a chronic disease that occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells, causing raised, red, scaly patches to appear on the skin.

“We look forward to bringing mirikizumab to market to provide patients with an additional treatment option that has the potential to provide near-complete or complete skin clearance as measured by PASI 90 and PASI 100, with sustained results at 52 weeks,” Johnsson said in a statement.

Mirikizumab is also in Phase III studies in inflammatory bowel diseases (IBD) including ulcerative colitis and Crohn's disease, an area where there are limited treatment options and patients are currently underserved. Lilly expects topline results for the Phase III induction data in ulcerative colitis in the spring of 2021 and for the Phase III Crohn's data in 2022. In addition to plaque psoriasis, Eli Lilly is focusing its dermatology program on atopic dermatitis and alopecia areata, a disease without an approved medicine in the United States.

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