Concert Pharmaceuticals presents Phase 2 data in Alopecia Areata
Concert Pharmaceuticals 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 less than0.001) relative to placebo in the percentage of patients achieving a greater than or equal to 50% relative change from baseline at 24 weeks using the Severity of Alopecia Tool. In the Phase 2 trial, the primary efficacy endpoint in the 12 mg twice-daily cohort was met with 58% of patients achieving a greater than or equal to 50% relative reduction in their overall SALT score from baseline compared to 9% for placebo, 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. For the 4 mg cohort, 21% of patients achieved a greater than or equal to 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. In the Phase 2 trial, the most common 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.