Concert says second late-stage study for hair loss therapy reached main goal (NASDAQ:CNCE) – Seeking Alpha


Blood sample for Alopecia Areata testing. A bald head in a person. Diffuse alopecia. Androgenic alopecia. Hair loss. Bald spots on the head. Trichology

Md Babul Hosen/iStock via Getty Images

Md Babul Hosen/iStock via Getty Images
Clinical-stage biotech Concert Pharmaceuticals (NASDAQ:CNCE) traded ~7% higher in the pre-market Monday after the company announced that its second Phase 3 trial for CTP-543 reached its primary endpoint in patients with alopecia areata.
An autoimmune disorder, alopecia areata causes patchy or complete scalp hair loss. The multinational THRIVE-AA2 trial was designed to evaluate the safety and efficacy of CTP-543 in 517 adult patients in the U.S., Canada, and Europe.
Based on topline data, the trial approached the primary efficacy endpoint of the percentage of patients achieving an absolute Severity of Alopecia Tool (SALT) score of 20 or less at Week 24 of treatment with statistical significance. The efficacy was seen for both 8 mg twice daily and 12 mg twice-daily dose of the oral therapy, compared to the placebo.
However, two patients in the 8 mg twice-daily arm and two patients in the 12 mg twice-daily arm developed herpes zoster (shingles). Out of five serious adverse events, only one in the 8mg arm was found to be treatment-related.
The data are yet to undergo peer-review, which typically precedes the publication in a medical journal.
Concert (CNCE) expects to file a New Drug Application (NDA) to the FDA in 1H 2023 seeking marketing authorization for CTP-543 based on these data and the data from THRIVE-AA1, the first late-stage trial for the therapy.

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