Significant hair regrowth seen with Concert’s alopecia areata candidate

Patients with alopecia areata achieved significant hair regrowth after treatment with CTP-543, according to phase 3 trial results released by Concert Pharmaceuticals in a press release.

The randomized, double-blind, placebo-controlled THRIVE-AA1 trial included 706 adult patients with moderate to severe alopecia areata and at least 50% scalp hair loss who were randomly assigned to receive either 8 mg or 12 mg of twice-daily CTP-543 — an investigational oral Janus kinase inhibitor — or placebo for 24 weeks.

Of the patients in the 12 mg group, 41.5% achieved an absolute Severity of Alopecia Tool (SALT) score of 20 or less at week 24, meaning at least 80% scalp coverage was achieved.

In the 8 mg group, 29.6% achieved a SALT score of 20, while 0.8% of those in the placebo group achieved the same.

“With these compelling phase 3 data, we believe that CTP-543 has the potential to be a best-in-class treatment for patients with alopecia areata, a disease that has long been ignored. We are extremely grateful to the patients and teams of clinical research professionals who participate in our trials,” James V. Cassella, PhD, chief development officer of Concert Pharmaceuticals, said in the release. “We’re working to change the treatment landscape and hope that CTP-543 will be one of the first FDA-approved treatment options for this serious disease.”

Full results of the study are expected to be published and submitted to the FDA as the basis for a new drug application.