Summary written by Anthony Gilding, HBSc, Director of Science & Research at CANAAF.

As you may have heard by now, CoNCERT Pharmaceuticals has been conducting a clinical trial titled THRIVE-AA1, which aims to investigate the efficacy of CTP543, a selective Janus Kinase (JAK) inhibitor for the treatment of moderate to severe alopecia areata (AA). Moderate to severe AA indicates that the person has lost at least 50% of the hair on their scalp. The drug works by inhibiting the proteins JAK1 and JAK2, both of which are involved in the mechanism(s) responsible for causing AA. They developed this drug and launched the clinical trial in response to an urgent need for an effective treatment for this stubborn and emotionally devastating disease. Recently, the pharmaceutical company has shared exciting news regarding the results!

At this time, the study has met the primary endpoint for scalp hair regrowth and key secondary endpoints at both doses. Moreover, they have found that a statistically significant proportion of patients treated with either 8 mg twice-daily or 12 mg twice-daily of CTP-543 experienced greater scalp regrowth compared to placebo. Statistical significance indicates that these results did not occur by chance and were indeed the effect of the drug. 41.5% of participants taking the 12 mg twice-daily dose achieved a Severity of Alopecia Tool (SALT) score of 20 or less, meaning that they regrew 80% or more of the hair on their scalp. What is most exciting is that statistically significant hair growth was observed in as early as 8 weeks!

With the promising results of this phase 3 trial, CoNCERT Pharmaceuticals believes that CTP543 has the potential to be a best-in-class treatment for AA. These results, along with the results of THRIVE-AA2 which will be released in the third quarter of 2022, will be used as the basis of the company’s New Drug Application (NDA) to the Food and Drug Administration (FDA) in the first half of 2023. This will be the first step in getting CTP543 on the market as a treatment for AA in the United States of America, and eventually globally.

CANAAF is super excited by these results and will be keeping a close eye on the study! Stay tuned for more updates! You can find the full press release here: https://www.businesswire.com/news/home/20220523005329/en/\

If you have any questions about this research, or alopecia areata in general, feel free to email Anthony Gilding at science@canaaf.org