Concert Pharmaceuticals (NASDAQ:CNCE) completed its open-label trial comparing once-daily versus twice-daily dosing of CTP-543 in alopecia areata patients.
Alopecia areata is an autoimmune disease that causes partial or complete loss of hair on the scalp and body. CTP-543 is a deuterium-modified ruxolitinib, which inhibits Janus kinases 1 and 2.
The trial assessed 57 adult alopecia areata patients who received either 8 mg of CTP-543 twice-daily or 16 mg of CTP-543 once-daily for 24 weeks. The trial measured the relative change in severity of alopecia tool, or SALT, score.
The company plans to report the study’s findings at a future medical meeting, however in a statement, Roger Tung, Concert’s president and CEO, said, “Based on the results observed, the twice-daily regimen is preferred, and we intend to utilize it in our clinical development program for CTP-543 going forward.”
“We believe that the findings from our dose regimen studies may be valuable to CTP-543’s intellectual property portfolio and therefore are not disclosing additional data from this study at this time,” he added.
Concert expects the data from its Phase 2 trials will support an end of Phase 2 meeting with the FDA in 2020, followed by initiation of Phase 3 testing later next year.
