Concert Pharmaceuticals Presents Positive Phase 2 Data in Alopecia Areata During Late-Breaker Session at EADV Congress
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today presented results from its recently completed Phase 2 dose-ranging trial 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. Patients in the study treated with either 8 mg twice-daily or 12 mg twice-daily of CTP-543 met the primary efficacy endpoint with statistically significant differences (p <0.001) relative to placebo in the percentage of patients achieving a ≥ 50% relative change from baseline at 24 weeks using the Severity of Alopecia Tool (SALT). These results were presented during the 28th European Academy of Dermatology and Venereology (EADV) Annual Congress in Madrid, Spain.
“We are very pleased that we were selected to present our safety and efficacy data for CTP-543 to the treatment community at this Congress. We believe the results from this dose-ranging study with our oral JAK inhibitor, CTP-543, set a new bar for clinical results in patients with moderate-to-severe alopecia areata,” stated James V. Cassella, Ph.D., Concert’s Chief Development Officer, who made the oral presentation at EADV. “We look forward to advancing the development of CTP-543 into Phase 3 evaluation next year, as we continue our efforts to bring a new treatment to patients with this serious autoimmune disorder that currently has no approved medications.”
In the Phase 2 trial, the primary efficacy endpoint in the 12 mg twice-daily cohort was met with 58% of patients achieving a ≥ 50% relative reduction in their overall SALT score from baseline compared to 9% for placebo (p <0.001), with statistically significant separation from placebo occurring at Week 12. In the 8 mg twice-daily cohort, 47% of patients achieved the primary endpoint compared to placebo (p <0.001). For the 4 mg cohort, 21% of patients achieved a ≥ 50% relative reduction in their overall SALT score from baseline, however there was not a statistically significant difference from placebo.
Data from the Patient Global Impression of Improvement scale showed 78% of the patients receiving 12 mg twice-daily and 58% of the patients receiving 8 mg twice-daily rated their alopecia areata as “much improved” or “very much improved” at Week 24. For both doses there was a statistically significant difference from placebo (p <0.001).
In the Phase 2 trial, the most common (≥10%) side effects in the 12 mg CTP-543 dose group were headache, nasopharyngitis, upper respiratory tract infection and acne. One serious adverse event of facial cellulitis was reported as possibly related to treatment. After a brief dosing interruption, treatment was continued and this patient completed the trial. No thromboembolic events were reported during the trial.