Benzinga | Oct 29, 2020 10:03AM EDT

Concert Pharma Reports Will Present CTP-543 Data From Long-Term Extension Study In Alopecia Areata During Late-Breaking Session At European Academy Of Dermatology And Venereology Virtual Congress

Concert Pharmaceuticals, Inc. (NASDAQ:CNCE) today presented initial data from the ongoing long-term, open-label 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 from this long-term extension study 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 vast majority of patients to date. These data were presented during the 29th European Academy of Dermatology and Venereology (EADV) Virtual Congress.

"We are pleased to offer patients participating in our trials the ability to continue to receive CTP-543 as part of our long-term assessment of the candidate," stated James V. Cassella, Ph.D., Concert's Chief Development Officer, who made the oral presentation at EADV. "In addition to providing participants the opportunity to continue treatment beyond the defined 24-week clinical trial period, we are also collecting important long-term safety data and evidence of CTP-543's effect on hair regrowth to support future registration. We are excited about our growing momentum as we advance CTP-543 with its Breakthrough Therapy designation and expect to begin our first Phase 3 trial of CTP-543 in patients with moderate to severe alopecia areata shortly."

More than 90% of eligible patients have enrolled in the CTP-543 long-term extension study. To date, approximately 130 patients have been dosed with CTP-543 for more than 1 year, and over 50 patients have been dosed for more than 1.5 years. Treatment with CTP-543 shows continued maintenance of hair regrowth across the long-term extension study. Patients continuing to receive 12 mg twice daily generally show consistent hair regrowth, with an average absolute SALT score of approximately 40 or less at entry and throughout the long-term extension study. Patients receiving 8 mg twice daily in the previously-completed Phase 2 trial who escalated to 12 mg in the long-term extension study generally show continued improvement of SALT scores at the higher dose.

CTP-543 has been generally well tolerated in the long-term extension study, with clinical labs appearing stable and the adverse events profile being generally consistent with that previously reported in the Phase 2 trials, the majority of which were reported as mild to moderate. The presentation reported that five serious adverse events have occurred in the long-term extension study, two of which were possibly related to CTP-543 and the other three of which were not or unlikely related to CTP-543.

Details from the oral presentation, entitled "Initial Results from a Long-Term, Open-Label Extension Study with CTP-543, an Oral Janus Kinase Inhibitor, in Patients with Moderate to Severe Alopecia Areata" is available in the Scientific Presentations section of Concert's website.