Concert Pharmaceuticals Presents Update on CTP-543 Long-Term Extension Study in Alopecia Areata During 2nd JAK Inhibitors Drug Development Summit
“With its Breakthrough Therapy designation, we are excited about the prospect of CTP-543 for the treatment of alopecia areata as we advance it through its Phase 3 clinical program. Through the Phase 3 program and long-term extension study we are building a robust body of data to support our New Drug Application with the FDA, which we plan to file in early 2023,” said
“We believe Janus kinase inhibitors, or JAKs, are an important mechanism in the treatment of autoimmune disorders, including alopecia areata,” said
CTP-543 has been generally well tolerated in the long-term extension study with only 4 of the 158 subjects entering the study discontinuing due to adverse events to date. Adverse events are consistent with those previously reported in the Phase 2 trials. Clinical labs for key hematology parameters appear stable across the long-term extension study relative to end of treatment in the Phase 2 trials.
Details from the oral presentation, entitled “Update on Long-Term Safety & Efficacy of CTP-543, an Oral JAK Inhibitor, for the Potential Treatment of Alopecia Areata” will be available at
About CTP-543 and Alopecia Areata
CTP-543 is an oral selective inhibitor of Janus kinases JAK1 and JAK2. The
Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect approximately 1 million Americans at any given time1. 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. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently no drugs approved by the FDA for the treatment of alopecia areata.
The FDA selected alopecia areata as one of eight new disease areas that it focused on under its Patient-Focused Drug Development Initiative (PFDDI) in 2016-2017. The goal of the PFDDI is to bring patient perspectives into an earlier stage of product development. Following the FDA’s Patient-Focused Drug Development meeting held in
Cautionary Note on Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including, among others, statements about our expectations regarding the development of CTP-543 and the timing of regulatory filings, and any other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation, timing and design of future clinical trials, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals and other factors discussed in the "Risk Factors" section of our most recent Quarterly Report on Form 10-Q filed with the
1 Benigno M. Clinical, Cosmetic and Investigational Dermatology 2020
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