Concert Pharmaceuticals, Inc. announced the presentation of data from its Phase 3 clinical trial, THRIVE-AA1. The presentation highlights THRIVE-AA1 study results evaluating Concert's oral investigational medicine CTP-543 in adult patients with moderate to severe alopecia areata, an autoimmune disorder that results in patchy or complete scalp hair loss. The THRIVE-AA1 data are being presented by Brett King, M.D., Department of Dermatology, Yale University School of Medicine and clinical investigator of THRIVE-AA1, during the 31(st) European Academy of Dermatology and Venereology (EADV) Congress Late Breaking News Session.

In the THRIVE-AA1 study, significant improvements in scalp hair regrowth compared to placebo were achieved at 24 weeks for patients taking 8 mg twice-daily and 12 mg twice-daily doses of CTP-543, as previously disclosed in the positive topline results reported by Concert earlier this year. Treatment with CTP-543 was generally well tolerated. The EADV presentation includes new data from the THRIVE--AA1 study showing the ability of CTP-543 to achieve more stringent criteria for hair regrowth than the study's primary endpoint of absolute Severity of Alopecia Tool (SALT) score of 20 or less (meaning 20% or less scalp hair loss) at Week 24.

Specifically, 21% and 35% of the patients in the CTP-543 8 mg twice-daily and 12 mg twice-daily dose groups, respectively, achieved a SALT score of 10 or less at Week 24, compared to 0% of patients in the placebo group (p<0.0001). Also, the relative change in SALT score from baseline was significantly different for the 12 mg twice-daily dose group compared to placebo (p<0.001) as early as Week 4. In addition, new data are presented showing that patients in the THRIVE-AA1 study with loss of eyebrow or eyelash hair at baseline treated with CTP-543 had significant improvement compared to placebo over the 24-week treatment period (p<0.001).