Eli Lilly + Incyte's baricitinib improved hair regrowth for alopecia areata patients in second phase III study

Eli Lilly and Company and Incyte announced results from a second Phase III trial (BRAVE-AA1) evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata (AA) . The data are consistent with findings from the first Phase III clinical trial, BRAVE-AA2, top-lined earlier this year. In both investigational trials, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint of hair regrowth across the two dosing regimens at Week 36 compared to patients treated with placebo. AA is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress, and currently has no therapies approved by the FDA. The BRAVE-AA trial program was designed to evaluate the efficacy and safety of baricitinib in adult patients with severe AA . The program consists of two trials: BRAVE-AA1 and BRAVE-AA2. BRAVE-AA1 is a multicenter, randomized, double-blind, placebo-controlled adaptive Phase II/III trial. Based on interim results of the Phase II portion of BRAVE-AA1 at Week 12, baricitinib 2-mg and 4-mg once-daily doses were selected for further evaluation in the Phase III portion of the study. BRAVE-AA2 is a multicenter, randomized, double-blind, placebo-controlled study evaluating the baricitinib 2-mg and 4-mg dosing regimens versus placebo. Both studies included adults with severe alopecia, defined in the BRAVE clinical trials as a Severity of Alopecia Tool (SALT) score greater than 50 (i.e., who had greater than 50% scalp hair loss), in addition to a current episode of AA lasting at least six months but no more than eight years. BRAVE-AA1 and BRAVE-AA2 Study Results In both studies, over the nine-month treatment period, patients with severe AA treated with baricitinib 2-mg and 4-mg doses experienced significantly greater scalp hair regrowth compared to patients treated with placebo based on physician's assessment. Results of BRAVE-AA1 showed that at Week 36,the proportion of patients reaching 80 percent or more scalp hair coverage was achieved by 35 percent (p less than 0.001) of patients treated with baricitinib 4-mg/day, 22 percent (p less than 0.001) of patients treated with baricitinib 2-mg/day and five percent of patients in the placebo group, meeting the primary endpoint. BRAVE-AA2 showed that at Week 36 the proportion of patients reaching 80 percent or more scalp hair coverage was achieved by 33 percent (p less than 0.001) of patients treated with baricitinib 4-mg/day, 17 percent (p less than 0.001) of patients treated with baricitinib 2-mg/day and three percent of patients in the placebo group, meeting the primary endpoint. Across both studies, the proportion of patients self-reporting at least 80 percent scalp hair coverage was significantly greater in the 2-mg and 4-mg groups compared to placebo (p less than 0.001) by Week 36. The most common treatment-emergent adverse events (TEAEs) in BRAVE-AA1 and BRAVE-AA2 included upper respiratory tract infections, headache and acne. No deaths or venous thromboembolic events (VTEs) were reported in the trials. The safety profile of baricitinib in the two studies was consistent with its known safety profile in patients with rheumatoid arthritis (RA) and atopic dermatitis (AD). Lilly will present detailed data from these studies at scientific meetings later this year and submit the results to peer-reviewed journals. Based on these results, Lilly plans to submit a supplemental New Drug Application (sNDA) to the FDA for baricitinib in AA in the second half of 2021, followed by submissions to other regulatory agencies around the world. In Q1 2020, baricitinib received Breakthrough Therapy designation from the FDA for the treatment of AA.