Less than two months after Concert Pharmaceuticals $CNCE rattled investors with the news that the FDA had placed a clinical hold on its drug CTP-543 for alopecia areata, an autoimmune condition linked to complete or partial hair loss, regulators have now taken the agency’s foot off the brakes.
But the biotech says it is also amending the trial design to test two low doses of the drug — 4 mg and 8 mg twice daily — versus a placebo before they carefully consider upping the dose.
Initially, the biotech said that the FDA had not cited any safety concerns in imposing the hold on the study. Calling a halt, the company said, was triggered by the need to take some time to review non-clinical tox studies.
“We believe the FDA is taking a measured approach for the development of Janus kinases inhibitors, or JAK inhibitors, for autoimmune dermatological disorders, including alopecia areata. Accordingly, we agreed to modify the design of our Phase IIa trial to evaluate CTP-543 in the patient population in a more step-wise fashion. It is important to note that CTP-543 has been well-tolerated in clinical evaluation to date and demonstrates a non-clinical safety profile consistent with JAK inhibition,” said Roger Tung, the CEO of Concert Pharmaceuticals. “Alopecia areata is an autoimmune disease for which there is a significant unmet medical need with no FDA-approved therapy, and we intend to be at the forefront of advancing a new oral treatment for alopecia areata patients.”
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