New medicine for baldness! The U.S. FDA awarded the new anticosis JAK1/2 inhibitor CTP-543 breakthrough drug qualification, treatment of severe baldness significant effect!

, July 09, 2020 /PRNewswire/ --BiovalleyBIOON/Concert Pharma is a clinical biopharmaceutical company that develops small molecule drugs for the treatment of central nervous system diseases,geneticdiseases, kidney diseases, inflammatory diseases and cancerThe company recently announced that the U.SFood and Drug Administration (
FDA) has granted it a breakthrough drug (BTD) for the oral JAK inhibitor CTP-543, which is used to treat moderate to severe baldness in adultsBaldness is aautoimmunedisease in which the immune system attacks hair follicles, causing local or complete hair lossAt present, theFDA has not been approvedto treat the treatment of bald drugsCTP-543 was discovered by modifying ruxolitinib using Concert's niobium chemical technology, a selective Janus kinase 1 and Janus kinase 2 (JAK1/2) inhibitor that has been approved in the United States under the brand name Jakafi for the treatment of certain blood diseasesRuxolitinib's xenon chemical modification sedituated to alter its human pharmacokinetics, thereby enhancing its use as a treatment for baldness Previously, the FDA had granted CTP-543 fast-track status (BTD) for the treatment of baldness baldness can cause some or all of the hair loss on the scalp or body, affecting as many as 650,000 people in the United States The scalp is the most common affected area, but any area of hair growth may be affected individually or with the scalp Baldness can occur at any age, and most patients begin to develop symptoms at age 40, affecting both women and men Baldness can be associated with serious psychological consequences, including anxiety and depression BTD is a new drug review channel created by the FDA in 2012 to accelerate the development and review of new drugs used to treat serious or life-threatening diseases and have initial clinical evidence that the drug can significantly improve the condition compared to existing therapeutic drugs The BTD-acquired drug is developed with closer guidance, including FDA senior officials, to ensure that patients are given new treatment options in the shortest possible time FDA granted CTP-543 treatment for moderate to severe predesinal BTD, based on positive data from a Phase II clinical study The results of the study were published in September 2019 this is a double-blind, randomized, placebo-controlled, sequential dose study conducted in adult patients with moderate to severe baldness and evaluated the efficacy and safety of CTP-543 In the study, 149 patients were randomly treated with CTP-543 (4 mg, 8 mg, 12 mg) or placebo at one of three doses, 2 times a day The study's main endpoint was the proportion of respondents at the 24th week of treatment, defined as the Hair Loss Severity Tool (SALT) score with a reduction of 50% relative to the baseline In the study, the patient entry criterion was at least 50% with SALT evaluation, and the average SALT score for all patients was about 88%, with 0% indicating no scalp hair loss and 100% indicating complete scalp hair loss All patients in the 12mg queue who completed 24 weeks of treatment had the opportunity to continue with a separate extended study to assess the long-term safety and efficacy of CTP-543 results showed that the study reached the main end of the treatment: in the 24th week of treatment, the 12mg cohort and 8mg queue had a significantly higher proportion of patients with a significantly higher proportion (58%, 47%, 9%, respectively) with a significantly higher salt score of 50% compared to the baseline (p-value-to-average 0.001) Twenty-one percent of patients in the 4mg queue reached the primary endpoint, but there was no significant difference compared to the placebo group In addition, at the 24th week of treatment, patients with a significantly higher proportion of 12mg and 8mg in the group (42%, 26%, 7) achieved a total SALT score of 20 (compared to placebo: p 0.001, p 0.05, respectively), which was the main end point of efficacy that the company intends to use in its key registered studies at the 24th week, the 12 mg dose and the 8 mg dose CTP-543 treatment group also showed significantly greater improvement in the patient's overall impression improvement scale (Patient Global Impression improvement scale), with significant differences in the 12mg queue and 8mg queue, which were 78%, and 58% of patients with a significant improvement in the "significantimprovement" or "very large improvement" compared to the patient's overall impression improvement scale the study, the overall tolerance of CTP-543 therapy was good The most common side effects of the 12mg queue (-10%) were headache, nasopharyngitis, upper respiratory tract infections and acne, and a severe adverse event of facial cellular tissue inflammation in the queue was reported as likely to be associated with the treatment; No thromboembolism events were reported during the trial as the next step in the CTP-543 clinical project, Concert plans to launch its Phase III clinical development program in the fourth quarter of 2020 (biovalleybioon.com) original source: CONCERT EURECEIVS FDA MIL THERAPY FOR CTP-543 FOR THE TREATMENT OF ALOPECIA AREATA