Concert Pharma Aces Second Trial in Alopecia

 

• Concert Pharmaceuticals Inc 
  CNCE+7.23%+ Free Alerts
   announced topline results from its second Phase 3 trial, THRIVE-AA2, evaluating CTP-543 in adult patients with moderate to severe alopecia areata, an autoimmune disorder that results in patchy or complete scalp hair loss. 
• The primary efficacy endpoint was met with statistical significance in the 8 mg twice-daily and 12 mg twice-daily dose groups relative to placebo. 
• A statistically significant proportion of patients treated with either 8 mg twice-daily or 12 mg twice-daily of CTP-543 experienced greater scalp regrowth compared to placebo. 
• The proportion of patients achieving a SALT score of 20 or less (meaning 20% or less scalp hair loss) was 38.3% in the 12 mg twice-daily dose group and 33% in the 8 mg twice-daily dose, compared to 0.8% in the placebo group.
• 47% of patients in the 8 mg twice-daily group and 52% in the 12 mg twice-daily group reported being "satisfied" or "very satisfied," compared to 2% of patients in the placebo group. 
• The safety profile seen with CTP-543 in THRIVE-AA2 was consistent with previous studies. 
• Concert plans to submit to FDA marketing application in 1H of 2023.

https://www.benzinga.com/general/biotech/22/08/28290507/concert-pharma-aces-second-trial-for-patchy-hair-loss-hopeful