Concert says second late-stage study for hair loss therapy reached main goal (NASDAQ:CNCE)
Scientific-stage biotech Live performance Prescription drugs (NASDAQ:CNCE) traded ~7% larger within the pre-market Monday after the corporate introduced that its second Section 3 trial for CTP-543 reached its main endpoint in sufferers with alopecia areata.
An autoimmune dysfunction, alopecia areata causes patchy or full scalp hair loss. The multinational THRIVE-AA2 trial was designed to judge the security and efficacy of CTP-543 in 517 grownup sufferers within the U.S., Canada, and Europe.
Based mostly on topline knowledge, the trial approached the first efficacy endpoint of the share of sufferers reaching an absolute Severity of Alopecia Device (SALT) rating of 20 or much less at Week 24 of therapy with statistical significance. The efficacy was seen for each 8 mg twice day by day and 12 mg twice-daily dose of the oral remedy, in comparison with the placebo.
Nevertheless, two sufferers within the 8 mg twice-daily arm and two sufferers within the 12 mg twice-daily arm developed herpes zoster (shingles). Out of 5 severe adversarial occasions, just one within the 8mg arm was discovered to be treatment-related.
The information are but to bear peer-review, which usually precedes the publication in a medical journal.
Live performance (CNCE) expects to file a New Drug Software (NDA) to the FDA in 1H 2023 in search of advertising authorization for CTP-543 primarily based on these knowledge and the info from THRIVE-AA1, the primary late-stage trial for the therapy.
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