Concert Pharmaceuticals Inc (NASDAQ:CNCE) stock is trading a bit lower in the pre-market session on Thursday. The stock has gained almost 4% over the past week.
Major Trigger:
Concert Pharmaceuticals Presents Update on CTP-543 Long-Term Extension Study in Alopecia Areata During 2nd JAK Inhibitors Drug Development Summit
Key Highlights:
- today will present an update from its ongoing open label, long-term extension study of the investigational medicine CTP-543 in patients with moderate to severe alopecia areata, an autoimmune disorder that results in patchy or complete hair loss. The data show that, relative to previous Phase 2 study results of CTP-543, hair regrowth assessed by the Severity of Alopecia Tool (SALT) was maintained or improved in the great majority of patients through one year of continuous dosing with 12 mg twice-daily of CTP-543.
- Approximately 57% of participants receiving 12 mg of CTP-543 twice-daily following 52 weeks of dosing achieved a clinically-meaningful SALT score of 20 or less. Dosing in the long-term extension study is ongoing, and patients completing the ongoing Phase 3 THRIVE-AA trials are eligible to enroll in the study. These data will be presented virtually during the virtual JAK Inhibitors Drug Development Summit.
Key Quote:
“With its Breakthrough Therapy designation, we are excited about the prospect of CTP-543 for the treatment of alopecia areata as we advance it through its Phase 3 clinical program. Through the Phase 3 program and long-term extension study we are building a robust body of data to support our New Drug Application with the FDA, which we plan to file in early 2023,” said James V. Cassella, PhD, Concert’s Chief Development Officer, who made the oral presentation at the Summit. “We are committed to understanding how alopecia areata affects the whole person and are working diligently to advance CTP-543 as one of the first FDA-approved therapies for this serious autoimmune condition.”
Market Reaction
As of 7:31, CNCE stock is down by 1.66% to $4.15. So far more than 3k shares have exchanged hands.
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