Concert Pharmaceuticals Inc. said the U.S. FDA lifted the clinical hold on its CTP-543 Phase 2a clinical trial for alopecia areata. The company will amend the protocol for the Phase 2a trial to evaluate two doses of CTP-543, each for a 24 week duration. Concert will resume enrollment in the Phase 2a trial later this month and expects to complete the trial in the second half of 2018.
"We believe the FDA is taking a measured approach for the development of Janus kinases inhibitors, or JAK inhibitors, for autoimmune dermatological disorders, including alopecia areata...It is important to note that CTP-543 has been well-tolerated in clinical evaluation to date and demonstrates a non-clinical safety profile consistent with JAK inhibition," said Roger Tung, Ph.D., president and CEO of Concert Pharmaceuticals.
In May 2017, the FDA informed the company that a review of certain non-clinical toxicology studies was required before proceeding with dosing in the Phase 2a trial. Concert submitted the requested non-clinical study reports, and in further discussions with FDA, agreed to amend the clinical protocol.