Concert Pharmaceuticals, has announced on Monday that an experimental therapy for Alopecia Areata, a severe form of hair loss from some or all areas of the body, might return virtually full heads of hair to up to 40 percent of patients.
alopecia areata hits up to 1.5 million adults in the US. Actress Jada Pinkett Smith is a renowned individual with alopecia.
The news comes after positive topline results from its recently completed Phase 3 clinical trial for the disorder in which the immune system destroys hair follicles, causing patchy or complete hair loss. Although alopecia areata can sometimes resolve itself in a few months, the condition often persists for years.
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Currently, no cure is known for the disorder. Even partial hair restoration might make a significant impact on those affected by the condition.
Brett King, M.D., Department of Dermatology, Yale University School of Medicine, and the clinical investigator said “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. There is a great need for treatments for this challenging disease, and the results from the trial suggest a potentially provide an important therapy for treating alopecia areata.”
About 700 individuals with moderate or severe alopecia areata participated in a trial of Concert’s CTP-543 twice-daily tablet. They had to have lost at least fifty percent of their scalp hair to qualify for the research. On average, the final group of participants had less than 16 percent of their hair remaining, and more than half of them were bald.
The trial’s goal was to regenerate enough hair to cover at least 80% of the scalp. After 24-week, the research reached this objective for 29.6% who received a medium dose, and 41.5% of those who received a high dose.
Earlier this year, Concert rival Eli Lilly & Company announced promising findings from two Phase 3 studies of baricitinib, an authorized medication for rheumatoid arthritis, as a possible therapy for alopecia areata.
After 36 weeks of therapy, Lilly’s medication showed comparable efficacy to that of Concert after 24 weeks. Nearly 39% of those who received the high dose of baricitinib saw hair regrowth on 80% of their heads.
Tofacitinib from Pfizer and ruxolitinib cream from Incyte have been evaluated for the disease.
Concert Pharma plans to submit the whole findings of this study for scientific publication and presentation soon. Preliminary results are expected in the third quarter of 2022. In the first half of 2023, a New Drug Application (NDA) is anticipated to be submitted to the U.S. Food and Drug Administration (FDA).