Eli Lilly and Co. and Incyte Corp. are working on atopic dermatitis (AD) from several angles and finding success. The most recent example is the positive top-line results from their collaborative phase III trial of baricitinib in treating adults with moderate to severe atopic dermatitis that show the oral selective JAK inhibitor met the study’s primary and secondary endpoints.
The good news dovetails with results from the companies’ other clinical trials in AD. On Tuesday, Incyte announced positive top-line results from its phase III TRuE-AD2 study evaluating the safety and efficacy of ruxolitinib cream, also a JAK inhibitor, for adolescent and adult patients with atopic dermatitis. And three weeks ago, Lilly acquired Dermira Inc. for $1.1 billion in cash, a deal that included lebrikizumab, now in two phase III studies for treating moderate to severe atopic dermatitis in adolescents and adults, ages 12 and older.
Lilly plans to continue developing the products in the indication despite a seeming overlap.
“Lilly’s acquisition of Dermira is consistent with the company’s vision of pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions for patients with skin-related diseases,” Lotus Mallbris, vice president of immunology development at Lilly, told BioWorld. “Compared to other inflammatory skin conditions, like psoriasis, there have been few treatment advancements for people living with AD. Since AD is a chronic, relapsing condition that can vary greatly from person to person, there is a critical need for multiple treatment options with different mechanisms of action. Lilly will continue the development plan of both baricitinib and lebrikizumab and is confident in each having potentially important roles to play in the treatment paradigm since AD is heterogeneous in nature.”
Lebrikizumab, a monoclonal antibody designed to bind IL-13 with high affinity, is now in two phase III studies for treating moderate to severe AD in adolescent and adult patients, ages 12 and older. The FDA granted fast track status for lebrikizumab (lebri) in December.
The field is dominated by Regeneron Pharmaceutical Inc.'s FDA-approved blockbuster, Dupixent (dupilumab). Some competition was kept at bay in early November as Anaptysbio Inc.'s phase IIb study of etokimab to treat moderate to severe atopic dermatitis saw each dosing arm fail to hit the primary endpoint.
Lilly and Incyte’s multicenter, double-blind, randomized, placebo-controlled phase III trial of baricitinib, BREEZE-AD5, designed for and conducted in North America, evaluated the efficacy and safety of 1-mg and 2-mg doses of baricitinib monotherapy for adults with moderate to severe AD. The 2-mg dose of baricitinib met the primary endpoint as defined by the proportion of participants achieving Eczema Area and Severity Index (EASI) 75 at week 16, and key secondary endpoints, including another measure of skin inflammation defined by clear or almost clear skin and at least a two-point improvement on the validated Investigator's Global Assessment (IGA) for AD (vIGA 0 or 1 at week 16), and reduced itch severity. The data show a “p” value of ≤0.001 for baricitinib compared to placebo by analysis, unadjusted for multiplicity. The primary endpoint was defined by the proportion of patients achieving at least a 75% change from baseline in their EASI scores at week 16.
On Jan. 28, Incyte posted positive top-line results from its randomized, vehicle-controlled, pivotal phase III TRuE-AD2 study evaluating the safety and efficacy of ruxolitinib cream in adolescent and adult patients (ages 12 and older) with AD. The trial met its primary endpoint, the proportion of participants achieving an Investigator’s Global Assessment Treatment Success, defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline at week eight.
Lilly put baricitinib up for a regulatory review in Europe for treating moderate to severe AD and said it will submit for U.S. and Japanese approval this year. It’s already approved for treating adults with moderately to severely active rheumatoid arthritis in the U.S., the EU and Japan.
On Thursday, Incyte stock (NASDAQ:INCY) drifted 2.47% lower to close at $73.14 per share.