Research & Development
Concert Pharmaceuticals Receives Fast Track Designation from US FDA for Alopecia Areata Treatment
17 January 2018 - - The US Food and Drug Administration has granted fast track designation to Lexington, Massachusetts-based clinical stage biopharmaceutical company Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) for CTP-543, an oral Janus kinase inhibitor, for the treatment of moderate-to-severe alopecia areata, the company said.
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.
Alopecia areata is an autoimmune disorder in which the immune system attacks hair follicles, resulting in patchy or complete hair loss.
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 US 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.
Concert Pharmaceuticals focuses on applying its deuterated chemical entity platform to create novel medicines designed to address unmet patient needs.
The company's approach starts with approved drugs in which deuterium substitution has the potential to enhance clinical safety, tolerability or efficacy. Concert has a broad pipeline of innovative medicines targeting autoimmune and inflammatory diseases and central nervous systems disorders.