Concert’s Patient-Reported Outcome Could Help Differentiate Its Alopecia Therapy

Strong patient-reported outcomes in its pivotal trials may help Concert Pharmaceuticals, Inc.’s alopecia areata candidate CTP-543 compete against heavyweights from Eli Lilly and Company and Pfizer Inc.; the deuterated formulation of ruxolitinib (Lilly/Incyte Corporation’s Jakafi) is on track for an early 2023 new drug application filing and is likely to be the third drug approval for the hair-loss condition.

Concert unveiled positive top-line data on 1 August from its Phase III THRIVE-AA2 study, which CEO Roger Tung called confirmatory of data reported in May for the Phase III THRIVE-AA1 study and said it is on track to file for approval in alopecia areata during the first half of 2023. Lilly obtained US Food and Drug Administration approval of Olumiant (baricitinib), a JAK inhibitor like CTP-543, in alopecia areata on 13 June, and Pfizer has its dual JAK3/TEK family kinase inhibitor ritlecitinib under FDA review with a June 2023 action date