Concert Pharmaceuticals Announces Initiation of Open Label Trial to Evaluate Once-Daily vs. Twice-Daily Dosing of CTP-543 in Patients with Alopecia Areata
“We are very pleased with the profile we have observed to date with the
8 mg twice-daily dose of CTP-543. This open label trial will allow us to
further understand CTP-543’s effect when dosed once daily,” said
Approximately 60 patients with moderate-to-severe alopecia areata are
expected to be enrolled in the open label trial, which will be conducted
As an additional study to inform the CTP-543 clinical program, Concert intends to conduct a food-effect trial to assess the relative bioavailability of oral doses of CTP-543 under fasted and fed conditions in 14 healthy volunteers in the first half of 2019.
Additional information about the CTP-543 clinical trials are available on www.clinicaltrials.gov.
About CTP-543 Interim Phase 2 Results
During the late-breaking clinical trials session at the
CTP-543 was discovered by applying Concert's deuterium chemistry technology to modify ruxolitinib, a drug which inhibits Janus kinases 1 and 2 (JAK1 and JAK2) and is commercially available under the name Jakafi® in the United States for the treatment of certain blood disorders. Deuterium modification of ruxolitinib was found to alter its human pharmacokinetics in ways which may enhance its use as a treatment for alopecia areata.
About Alopecia Areata
Alopecia areata is an autoimmune disease that results in partial or complete loss of hair on the scalp and body that 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 with the majority of patients initially having symptoms by age 40. It is believed to equally affect 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.
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 statements about our expectations for clinical development of CTP-543, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “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 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, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of our most recent Annual Report on Form 10-K 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.