INDIANAPOLIS - Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today new data for baricitinib (marketed as OLUMIANT) will be presented at the annual Fall Clinical Dermatology meeting taking place virtually October 29-November 1, 2020.

The data underscore Lilly's commitment to providing medicines for dermatologic diseases that have high unmet need, including alopecia areata (AA). AA is an autoimmune disorder that can cause unpredictable hair loss on the scalp, face and other areas of the body.

Data from the Phase 2 portion of BRAVE-AA1, an ongoing Phase 2/3 study evaluating the safety and efficacy of baricitinib in adult patients with AA will be shared. The study included adult patients with a current episode of AA lasting for 6 months to 8 years with a Severity of Alopecia Tool (SALT) score 50 (i.e. who had 50% scalp hair loss) and no spontaneous improvement over six months prior to screening. In the Phase 2 portion, patients were randomized to oral baricitinib 1-mg, 2-mg, 4-mg or placebo once daily, in order to identify up to two doses for the Phase 3 portion. Interim analyses were conducted after patients completed 12 and 36 weeks of treatment, the latter for the primary endpoint of the Phase 2 part of the study. At Week 36, the proportion of patients achieving the primary endpoint of SALT 20 defined as having 20% or less of scalp hair loss and considered as clinically meaningful improvement, was significantly greater in baricitinib 2-mg (33.3%, p=0.016), and 4-mg (51.9%, p=0.001) groups compared to placebo (3.6%). Based on the interim results of the Phase 2 part of the study, the Phase 3 portion of BRAVE-AA1 and an additional Phase 3 trial (BRAVE-AA2) were initiated and are ongoing to assess the efficacy and safety of the 2-mg and 4-mg doses of baricitinib relative to placebo.

'Alopecia areata is a challenging disease that currently has no FDA-approved treatment options, making it difficult for healthcare providers to best serve the needs of these patients,' said Brett King, MD, PhD associate professor of Dermatology at Yale School of Medicine. 'I'm encouraged by the results of this study which support the therapeutic potential of baricitinib and look forward to further evaluating its ability to help the community of those affected by alopecia areata.'

The proportion of adult patients achieving no hair loss or limited hair loss on the patient-reported outcomes (PRO) for scalp hair assessment were significantly greater in the 2-mg and 4-mg groups compared to placebo (p

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