Eli Lilly and Incyte have reported positive results from two Phase III trials evaluating their oral JAK inhibitor baricitinib in alopecia areata (AA).
AA is an autoimmune condition that causes hair to fall out in small patches, with this hair loss affecting the scalp, face and sometimes other areas of the body.
There are currently no US Food and Drug Administration (FDA) approved therapies for the condition, Lilly and Incyte said in a statement.
In two studies – BRAVE-AA1 and BRAVE-AA2 – patients with severe AA were treated with either baricitinib 2 mg or 4 mg doses.
Results from the BRAVE-AA1 study showed that at week 36, the number of patients reaching 80% or more scalp hair coverage was 35% for those treated with baricitinib 4 mg, 22% for baricitinib 2 mg and 5% of patients in the placebo group.
Similarly in the BRAVE-AA2 study, at week 36 the proportion of patients reaching 80% or more scalp hair coverage was 33% for those receiving baricitinib 4 mg, 17% of patients treated with baricitinib 2 mg and 3% of patients in the placebo group.
The most common treatment-emergent adverse events in the two studies includes upper respiratory tract infections, headache and acne. The safety profile of baricitinib across both studies was consistent with the drug’s known safety profile in patients with rheumatoid arthritis (RA) and atopic dermatitis (AD).
“The positive results from our Phase III trials of baricitinib in alopecia areata bring us one step closer to potentially providing an approved treatment option to people affected by this serious autoimmune disease,” said Lotus Mallbris, vice president of immunology development at Lilly.
“We look forward to discussing with global regulators data from the BRAVE-AA clinical trial programme for this important potential treatment, which could be the first approved for people living with alopecia areata,” she added.