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Lilly's Crohn's Disease Candidate Meets Phase II Study Goals

Zacks Equity Research

Eli Lilly and Company LLY announced that a phase II study evaluating its pipeline candidate mirikizumab in patients with moderately-to-severely active Crohn's disease (“CD”) met the primary and secondary endpoints.

Data from the phase II SERENITY study showed that treatment with mirikizumab led to significant reductions in clinical and endoscopic measures of disease activity at 12 weeks compared to placebo. The data were presented at Digestive Disease Week medical conference in San Diego, CA. Lilly plans to begin phase III studies on mirikizumab in Crohn's disease later this year. Mirikizumab is already being evaluated in phase III studies in other immune diseases, psoriasis and ulcerative colitis.

Some popular drugs approved to treat Crohn's disease are AbbVie’s ABBV Humira and UCB’s Cimzia, among others while several others like AbbVie’s newly approved psoriasis drug Skyrizi (risankizumab), Theravance Biopharma, Inc.’s TBPH JAK inhibitor TD-1473 Galapagos and Gilead’s GILD filgotinib and RedHill Biopharma Ltd  RHB-104 are in late-stage studies for CD.

Immunology is a key therapeutic area for Lilly and its portfolio includes popular drug Taltz, which is marketed for the treatment of psoriasis and psoriatic arthritis. Meanwhile, regulatory applications seeking approval of Taltz for axial spondyloarthritis are also under review with the FDA. Lilly is also seeking to expand its immunology pipeline. In the first quarter, Lilly announced global licensing and research collaboration with two companies, ImmuNext, Inc. and Avidity Biosciences, Inc to make new medicines in immunology and autoimmune diseases.

Lilly’s shares have risen 0.7% this year so far against the industry’s decline of 1.2%.


Lilly currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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