USA-based Concert Pharmaceuticals (Nasdaq: CNCE) has announced that the US Food and Drug Administration (FDA) has lifted the clinical hold on its CTP-543 Phase IIa clinical trial for alopecia areata, a type of hair loss.
The FDA halted the trial in May, saying that a review of certain non-clinical toxicology studies was required before proceeding with dosing. Concert has submitted the requested non-clinical study reports and in further discussions with the FDA, agreed to amend the clinical protocol.
There will now be an evaluation of two doses of CTP-543, each for a 24-week duration. Concert will resume enrollment in the trial later this month and expects to complete the trial in the second half of 2018.
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