Concert Pharmaceuticals, Inc. (now owned by Sun Pharma) has just completed a clinical trial showing significant improvement for some people with alopecia after taking the brand's pill to try to regrow hair. The trial involved "adult patients with moderate to severe alopecia areata, an autoimmune disorder that results in patchy or complete scalp hair loss," the company states. Patients enrolled in the trial, THRIVE-AA1, were required to have at least 50 percent scalp hair loss due to alopecia areata, and most had greater hair loss than required.
A statistically significant proportion of patients treated with the medication in either of two doses experienced greater scalp regrowth compared to those taking a placebo, according to Concert Pharmaceuticals. The proportion of patients achieving 80 percent or more scalp hair coverage was 41.5% percent in the higher dose group and 29.6% in the lower dose group. The company further reports that the treatment, called CTP-543, was generally well-tolerated.
According to the company, alopecia areata may affect up to approximately 1.5 million Americans at any given time. The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. There are currently no drugs approved by the FDA for the treatment of alopecia areata.
“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,” says Brett King, MD, Department of Dermatology, Yale University School of Medicine and clinical investigator of THRIVE-AA1. “There is a great need for treatments for this challenging disease, and the results from the THRIVE-AA1 trial suggest that CTP-543 may potentially provide an important therapy for treating alopecia areata.”
Reported in the New England Journal of Medicine in early May 2022, Eli Lilly achieved similar results from its trial of Olumiant® (baricitinib) medication. It is considered likely that both Eli Lilly and Concert Phamaceuticals will ask the FDA for approval sometime in 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," says James V. Cassella, Ph.D., Chief Development Officer of Concert Pharmaceuticals. “We are extremely grateful to the patients and teams of clinical research professionals who participate in our trials. 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.”
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