Top-line results from the first two cohorts of its Phase IIa trial evaluating investigational treatment CTP-543 in patients with moderate-to-severe alopecia areata, an autoimmune disorder in which the immune system attacks hair follicles, resulting in patchy or complete hair loss, have been released today by Concert Pharmaceuticals (Nasdaq: CNCE).
At 24 weeks, patients treated with an 8mg twice-daily dose of CTP-543 met the primary efficacy endpoint versus placebo (p <0.001). At this dose, significant differences from placebo were observed beginning at Week 12. Regrowth of hair did not appear to plateau at Week 24. Treatment with CTP-543 was generally well tolerated. Dosing in a 12mg twice-daily cohort is currently underway. Complete study results are expected to be presented at a future medical meeting. Compared to placebo, a significant relative reduction in mean SALT score was first observed in the 8mg cohort at Week 12 (p <0.05).
“We are very pleased by these initial efficacy and tolerability data for CTP-543 in patients with moderate-to-severe alopecia areata. We believe that the extent of efficacy and tolerability of CTP-543 to date supports its further development,” said, James Cassella, chief development officer, adding: “We look forward to completing the final dosing cohort in this Phase IIa trial and advancing the program into later stage clinical trials.”
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