Baricitinib improved hair regrowth for alopecia patients in Phase III study

There was good news today for Eli Lilly and Company (NYSE: LLY) and Incyte (Nasdaq: INCY) today, as they released positive results from a second Phase III trial (BRAVE-AA1) evaluating the efficacy and safety of once-daily baricitinib 2mg and 4mg 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.

Earlier this month, the companies announced disappointed results of COV-BARRIER, a Phase III study evaluating baricitinib 4mg once daily plus standard of care (SoC) versus placebo plus SoC for the treatment of hospitalized COVID-19 patients. Approved under the trade name Olumiant, baricitinib is primarily a rheumatoid arthritis therapy.

In both investigational alopecia 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 US Food and Drug Administration.