Concert Pharma Aces Second Trial For Patchy Hair Loss Hopeful

Concert Pharmaceuticals Inc CNCE 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.
Related: Concert Pharma's CTP-543 Shows Clinical Efficacy Against Scalp Hair Loss.
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.
Price Action: CNCE shares are up 8.57% at $6.08 on the last check Monday.