On August 1st, 2022, Concert Pharmaceuticals announced positive topline results from its second Phase 3 clinical trial, THRIVE-AA2, evaluating its oral investigational medicine CTP-543 in adult patients with moderate to severe alopecia areata. The efficacy endpoint of this clinical trial was the percentage of patients achieving a Severity of Alopecia Tool (SALT) score of 20 or less at week 24. The SALT score refers to the percentage of hair lost on the scalp. This endpoint was met with statistical significance in the 8 mg twice daily and 12 mg twice daily groups, compared to the placebo group. Statistical significance means that the hair growth was the result of CTP-543 and did not occur by chance. The company further reported that CTP-543 was generally well-tolerated by patients.
With the successful completion of THRIVE-AA1 and THRIVE-AA2, Concert Pharmaceuticals is now working to prepare their New Drug Application (NDA) for the Food and Drug Administration (FDA) in the first half of 2023. If approved by the FDA, this will be the second systemic drug approved for the treatment of alopecia areata, after the recently approved Olumiant (baricitinib).
These are incredibly encouraging results and reflect the new era of scientific innovation that we’re living in! CANAAF will be following Concert Pharmaceuticals closely for any developments they make and will be sure to share the news with our community!
Written by Anthony Gilding, HBSc