Concert Pharmaceuticals Inc., an American pharmaceutical company, announced the results of its latest clinical trial, which seeks the implementation of a drug that helps cure alopecia areata.
Taking CTP-543, the name of the drug, has shown amazing results. 41.5% of subjects taking 12 milligram doses twice daily for 24 weeks had an increase in their scalp coverage of 80%.
“Today marks an important milestone in advancing new treatments for alopecia areata. I am very happy to see such positive results from the first phase 3 trial with CTP-543,” Brett King, clinical investigator for THRIVE-AA1, said in a statement.
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How has the clinical trial worked?
For the third phase, 706 adults (between 18 and 65 years old) with alopecia, from the United States, Canada and the United Kingdom, were studied. This group was divided into three: one was given a placebo, another an 8-milligram dose twice a day, and the other a 12-milligram pill twice a day.
To sign up for the show, subjects had to have at least 50% hair loss. This was evaluated according to the Salt score, which measures from 0 to 100 the amount of hair missing, with ‘0’ being no loss and ‘100’ being total hair loss.
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The average Salt score at the start of the trial was 85.9%, which corresponds to less than 15% average hair coverage on the scalp.
amazing results
Patients who were treated with the 12-milligram dose they achieved a Salt score of 20, which means that they recovered 80% of their hair. On the other hand, those who took two 8-milligram doses daily had a 29.6% restoration. Finally, patients treated with placebo recovered only 0.8%.
“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 been ignored for a long time. We are extremely appreciative of the patients and teams of clinical research professionals involved in our trials,” said James V. Cassella, director of development for Concert Pharmaceuticals.
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Concert Pharmaceuticals Reports Positive Topline Results for First CTP-543 Phase 3 Clinical Trial in Alopecia Areata https://t.co/ESrzwVs9iu
— CONCERT (@ConcertPharma) May 23, 2022
The group said the drug was “generally well tolerated” as it “the most common side effects (≥5%) in any dose group were headache, acne, upper respiratory tract infection, increased creatine kinase levels, covid-19 infection, and nasopharyngitis,” they reported in the journal Business Wire, in which the study was published.
The company hopes to submit the data obtained for future scientific publications and collect it to form the basis of a new drug application that can be submitted to the Food and Drug Administration (FDA) in the first half of 2023.
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