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Concert's CTP-543 Receives the US FDA's Breakthrough Therapy Designation to Treat Alopecia Areata

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Concert's CTP-543 Receives the US FDA's Breakthrough Therapy Designation to Treat Alopecia Areata

Shots:

  • The BTD is based on a P-II study assessing CTP-543 (4/8/12mg- bid) vs PBO in 149 patients with moderate-to-severe alopecia areata
  • Results: 8 & 12mg doses of CTP-543 met its 1EPs with differences in the percentage of patients achieving a ≥ 50% relative change from baseline @24wks. as measured by SALT. Therapy was well-tolerated and showed significant hair regrowth
  • CTP-543 is a JAK1 & JAK2 inhibitor and has received the US FDA’s FTD for AA. The company plans to initiate a P-III study in Q4’20

 ­ Ref: Businessswire | Image: Twitter

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