FDA lifts clinical hold on Concert drug
- The Food and Drug Administration has lifted its clinical hold on a Phase 2a study of Concert Pharmaceuticals' hair loss drug CTP-543 following review of toxicology data, the biotech announced Monday.
- The study will be amended to evaluate two doses of CTP-543 over 24 weeks and will resume enrollment later in July. Concert expects the trial to complete in the second half of 2018.
- The primary outcome measure will look at the severity of alopecia tool (SALT) at 24 weeks. There is potential to amend the study to include higher doses of CTP-543 if required, Concert said.
Back in May, the FDA's clinical hold on CTP-543, a modified version of Incyte's JAK inhibitor Jakafi (ruxolitinib), caused the company's stock to fall by almost 10%.
Lifting the hold, which followed scrutiny of non-clinical toxicology studies and discussion of clinical protocol amendments, is good news for Concert Pharmaceuticals and the company is now moving forward with development of what could be the first approved treatment for alopecia areata.
An autoimmune disease, alopecia areata results in partial or complete hair loss over the scalp and body, affecting up to 650,000 people in the U.S. There is no current FDA-approved therapy.
"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 2a trial to evaluate CTP-543 in the patient population in a more step-wise fashion," said Roger Tung, president and CEO of Concert Pharmaceuticals, in a statement.
Not everyone is happy with CTP-543's development. Incyte has requested an inter partes review of Concert's patent, challenging Concert's patent claims on the drug.
- Concert Pharmaceuticals Press release
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