Effective treatment for hair loss! Reedretinib qualified for FDA breakthrough therapy

The FDA's decision is based on the excellent efficacy of CTP-543 in The Treatment of Moderate lysic Patients in Phase II Clinical StudiesThe Phase II study used a randomized, double-blind, placebo-controlled, sequential dose design to evaluate the safety and efficacy of CTP-543 in patients with severe baldness in adults149 patients were given a random group of CTP-543 4, 8, 12 mg or placebo 2 times a day, with the study's main endpoint being the 24th week of the hair loss severity tool (SALT) score with a relative baseline improvement of 50%results showed that the SALT scores at the 24th week of CTP-543 8mg and 12mg treatment group improved by an average of 78% and 86% respectively compared to the baseline, and the proportion of patients with a lower SALT score of 50% compared to the baseline was statistically different (58% vs 47% vs 9%) and reached the primary endpoint of the study, there was a significant difference between the number of patients with a SALT score of 2 mg and 20 at week 24 of 22 mg treatment group, compared to the placebo control groupThis indicator will be the end indicator set by Concert for subsequent CTP-543 key registration studiesIn terms of treatment response, 12 mg is faster than 8 mg, and the difference between the two effective doses will be formally evaluated in subsequent Phase III studiesIn terms of safety, CTP-543 was well tolerated, with 1 case of severe adverse events in the 12 mg dose group, but the patient finally completed clinical studies after a short pauseNote: Cut in the original text