- Concert Pharmaceuticals Inc CNCE has announced topline results from its Phase 3 THRIVE-AA1 trial of CTP-543 in adult patients with moderate to severe alopecia areata (AA).
- AA is an autoimmune disorder resulting in patchy or complete scalp hair loss.
- The study’s primary endpoint of the percentage of patients achieving an absolute Severity of Alopecia Tool (SALT) score of 20 or less at Week 24 of treatment was met with statistical significance in the 8 mg and 12 mg 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 than placebo.
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- The proportion of patients achieving a SALT score of 20 or less was 41.5% in the 12 mg group and 29.6% in the 8 mg group, compared to 0.8% in the placebo group, at the 24-week endpoint.
- These data, along with data from THRIVE-AA2, a second Phase 3 trial, will form the basis of the FDA marketing application planned in 1H of 2023, assuming positive results from THRIVE-AA expected in Q3 of 2022.
- Price Action: CNCE shares are up 8.69% at $4.88 during the premarket session on the last check Monday.
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