Concert Pharmaceuticals Presents CTP-543 Data from Long-Term Extension Study in Alopecia Areata During Late-Breaking Session at EADV Congress
“We are pleased to offer patients participating in our trials the ability to continue to receive CTP-543 as part of our long-term assessment of the candidate,” stated
More than 90% of eligible patients have enrolled in the CTP-543 long-term extension study. To date, approximately 130 patients have been dosed with CTP-543 for more than 1 year, and over 50 patients have been dosed for more than 1.5 years. Treatment with CTP-543 shows continued maintenance of hair regrowth across the long-term extension study. Patients continuing to receive 12 mg twice daily generally show consistent hair regrowth, with an average absolute SALT score of approximately 40 or less at entry and throughout the long-term extension study. Patients receiving 8 mg twice daily in the previously-completed Phase 2 trial who escalated to 12 mg in the long-term extension study generally show continued improvement of SALT scores at the higher dose.
CTP-543 has been generally well tolerated in the long-term extension study, with clinical labs appearing stable and the adverse events profile being generally consistent with that previously reported in the Phase 2 trials, the majority of which were reported as mild to moderate. The presentation reported that five serious adverse events have occurred in the long-term extension study, two of which were possibly related to CTP-543 and the other three of which were not or unlikely related to CTP-543.
Details from the oral presentation, entitled “Initial Results from a Long-Term, Open-Label Extension Study with CTP-543, an Oral Janus Kinase Inhibitor, in Patients with Moderate to Severe Alopecia Areata” is available in the Scientific Presentations section of Concert’s website.
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 up to 700,000 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 on the progress of clinical development of CTP-543 and the timing of initiation of future clinical trials, 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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