Concert Pharmaceuticals Successfully Completes Open Label Trial of CTP-543 in Patients with Alopecia Areata
“Based on the results observed, the twice-daily regimen is preferred, and we intend to utilize it in our clinical development program for CTP-543 going forward,” said
The dose regimen trial (NCT03811912) was a randomized, multi-center study to evaluate the efficacy and tolerability of once-daily versus twice-daily oral dosing of CTP-543, in adult patients with moderate-to-severe alopecia areata. Fifty-seven patients in the trial were randomized to receive CTP-543 either 8 mg twice-daily or 16 mg once-daily over a 24-week treatment period. The trial measured the relative change in Severity of Alopecia Tool (SALT) score between Week 24 and baseline.
Data from the Company’s Phase 2 trials will support an end of Phase 2 meeting with the
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 650,000 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
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 availability of clinical trial data, and any other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “will” 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 of future clinical 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 Fricke M. Epidemiology and Burden of alopecia areata: a systemic review. Clinical, Cosmetic and Investigational Dermatology. 2015; Vol 8. 397-403.
Justine E. Koenigsberg (Investors)
Concert Pharmaceuticals, Inc.
Kathryn Morris (media)
The Yates Network