Lilly, Incyte Report Positive Data for JAK Inhibitor in Phase III Alopecia Trial

The topline data from the BRAVE-AA2 study in 546 adults showed both 2 mg and 4 mg doses of Olumiant regrew hair in adult patients with more than 50% scalp hair loss, compared with placebo.

New Phase III data for announced today for Olumiant (baricitinib), already marketed by Eli Lilly and Incyte for rheumatoid arthritis, shows efficacy for the Janus kinase 1 (JAK1)/JASK2 inhibitor in severe alopecia areata. The topline data from the BRAVE-AA2 study in 546 adults showed both 2 mg and 4 mg doses of Olumiant regrew hair in adult patients with more than 50% scalp hair loss, compared with placebo.

According to the companies, the improvement was statistically significant for both doses at 36 weeks in patients with an episode lasting between 6 months and 8 years of more than 50% hair loss. Patients were enrolled at sites on four continents. Lilly and Incyte expect data from a second alopecia areata trial later this year.

Lilly received an Emergency Use Authorization last year from U.S. Food and Drug Administration (FDA) for Olumiant in combination with Gilead Science’s Remdesivir for hospitalized patients diagnosed with COVID-19 who require supplemental oxygen or ventilation. The companies are also awaiting approval decisions sometime this year from the European Commission and FDA for Olumiant to treat moderate to severe atopic dermatitis, and a European Medicines Agency panel gave the therapy a green light last fall. Lilly presented positive Phase III data from its BREEZE-AD3 trial last year.

Detailed safety data from BRAVE-AA2 was not made available, but Lilly and Incyte reported no deaths, major adverse cardiovascular events, or venous thromboembolic events in the study.

They added that the safety profile was consistent with rheumatoid arthritis and atopic dermatitis patients on Olumiant. But the immunosuppressant is marketed with a black box warning about the risk of patients developing serious infections, lymphoma, or thrombosis, possibly leading to hospitalization or death.

There are no FDA-approved therapies for alopecia areata, an autoimmune disease that causes patchy body hair loss, especially on the scalp and face.

Olumiant received Breakthrough Therapy designation from FDA for alopecia areata a year ago, one of several medicines to do so in recent years. The others include Pfizer’s oral JAK3 inhibitor ritlecitinib, currently in Phase III testing for the indication in patients 12 and older in China, the U.S., and Canada. Ritlecitinib is also in Phase II testing for rheumatoid arthritis, ulcerative colitis, Crohn’s disease, and vitiligo.

Concert Pharmaceuticals, whose CTP-543 oral inhibitor of JAK1 and JAK2 is also in Phase III testing for alopecia areata, received its Breakthrough Therapy designation last year. Concert and Pfizer have both announced FDA Fast Track designations for their drug candidates as well.

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