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New phase 3 data indicates that a statistically significant number of patients treated with either 8 mg twice-daily or 12 mg twice daily CTP-543 experienced greater scalp regrowth compared to those on placebo
Concert Pharmaceuticals announced positive phase 3 data from THRIVE-AA1 indicating that the trial met its primary endpoint regarding scalp hair regrowth in adult patients with moderate to severe alopecia areata following treatment with the oral investigational medicine CTP-543.
THRIVE-AA1 was a randomized, double-blind, placebo-controlled clinical trial that featured 706 adult patients age 18-65 with moderate to severe alopecia areata from several sites the U.S., Canada and Europe.
The phase 3 trial investigated the regrowth of scalp hair after 24 weeks of dosing using the SALT score, and eligible patients were randomized to receive either 8 mg twice-daily or 12 mg twice-daily of CTP-543 or placebo for 24 weeks.
A statistically significant number of patients treated with either 8 mg twice-daily or 12 mg twice daily CTP-543 experienced greater scalp regrowth compared to those on placebo. Additionally, the proportion of patients treated with the oral medicine who achieved a Severity of Alopecia Tool (SALT) score of 20 or less at week 24 of the study was 41.5% in the 12 mg twice-daily dose group and 29.6% in the 8 mg twice-daily dose group.
Notably, all key secondary endpoints were met with statistical significance in both dose groups, which included the percentage of responders on a Hair Satisfaction Patient Reported Outcome (PRO) scale at Week 24 and the percentage of patients achieving absolute SALT scores of 20 or less at each of Weeks 20, 16, 12 and 8.
The safety profile seen with CTP-543 in THRIVE-AA1 was consistent with previous studies, with common adverse side effects including headache, acne, upper respiratory infection, increased kinase levels, COVID-19 infection and nasopharyngitis.
“Today marks an important milestone in advancing new treatments for alopecia areata, and I’m so happy to see such positive results from the first Phase 3 trial with CTP-543,” said Brett King, M.D., Department of Dermatology, Yale University School of Medicine and clinical investigator of THRIVE-AA1.
King cited a “great need” for treatments regarding alopecia areata, adding that the data from THRIVE-AA1 suggested a promising therapeutic option for those struggling with the disease.
Concert Pharmaceuticals intends to utilize the new data from THRIVE-AA1, along with data from the second phase 3 trial, THRIVE-AA2, to form the basis of a New Drug Application (NDA), to be submitted to the US Food and Drug Administration (FDA) in the first half of 2023.
“With these compelling Phase 3 data, we believe that CTP-543 has the potential to be a best-in-class treatment for patients with alopecia areata, a disease that has long been ignored. We are extremely grateful to the patients and teams of clinical research professionals who participate in our trials,” said James V. Cassella, Ph.D., Chief Development Officer of Concert Pharmaceuticals. “We’re working to change the treatment landscape and hope that CTP-543 will be one of the first FDA-approved treatment options for this serious disease.”