FDA Grants Fast Track Designation to Concert Pharmaceuticals' CTP-543 for the Treatment of Alopecia Areata
CTP-543 is a Novel JAK Inhibitor in Phase 2 for Alopecia Areata as Potential First-in-Class Treatment
Fast Track designation is a process designed to facilitate the
development and expedite the review of new therapies to treat serious
conditions and address unmet medical needs. With Fast Track designation,
early and frequent communications between the
"Fast Track designation recognizes that alopecia areata is a serious
disease in need of effective treatments. We look forward to
collaborating with the
Concert is conducting a multi-center, double-blind, randomized, placebo-controlled Phase 2a trial to evaluate the safety and efficacy of CTP-543 in adults with moderate-to-severe alopecia areata. For additional information on the ongoing CTP-543 Phase 2a trial, visit www.clinicaltrials.gov.
About CTP-543 and Alopecia Areata
CTP-543 was discovered by applying Concert's deuterium chemistry technology to modify ruxolitinib, a drug which selectively 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. Ruxolitinib has been used to treat alopecia areata in academic settings, including an investigator-sponsored clinical trial, and has been reported to promote hair growth in individuals with moderate-to-severe disease.
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 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 U.S. Food and Drug Administration (FDA) for the treatment of alopecia areata. Deuterium modification of ruxolitinib was found to alter its human pharmacokinetics in ways which may enhance its use as a treatment for 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) meetings in 2016-2017. The goal of the PFDDI is to bring patient perspectives into an earlier stage of product development. The meeting to discuss alopecia areata was held on Monday, September 11, 2017. Additional information is available online at: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm554443.htm
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
1 Fricke M. Epidemiology and Burden of alopecia areata: a systemic review. Clinical, Cosmetic and Investigational Dermatology. 2015; Vol 8. 397-403.
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