New drug for atopic dermatitis! Ruxolitinib cream, a Jak1 / 2 inhibitor, has been successfully used in the treatment of critical phase III of adolescent adult patients!

January 29, 2020 / Biovalley bio on / -- Incyte company recently published the positive top line results of random, excipient control and critical stage III study (nct03745651) on the evaluation of ruxolitinib cream in the treatment of atopic dermatitis (AD) in adolescents and adults (age ≥ 12 years) This study is part of the clinical trial project of true-ad2 The data shows that the study has reached the main end point Compared with excipients, a higher proportion of patients receiving 0.75% and 1.5% ruxolitinib cream achieved investigator's overall assessment of treatment success (iga-ts) at week 8, defined as IgA score of 0 (complete removal of skin lesions) or 1 (almost complete removal of skin lesions) and improvement of at least 2 points relative to baseline In the study, the overall efficacy and safety profile of ruxolitinib cream was consistent with the previous data, and no new safety signal was observed The long-term safety component of the study will continue as planned Data from the study will be released at the upcoming medical conference "These positive top line results enhance the potential of ruxolitinib cream and, if approved, will provide a much-needed, effective, non steroidal treatment option for AD patients," said Jim Lee, vice president, inflammation and autoimmunity group, Incyte We look forward to receiving the results of the second ongoing study, tree-ad1 (nct03745638), in a key clinical trial later this quarter, and sharing these data with the medical community as part of our commitment to develop new first-line treatment options for these patients " Ruxolitinib cream is a patent formulation of selective Janus kinase 1 and Janus kinase 2 (Jak1 / JAK2) inhibitor ruxolitinib from Incyte, which is specially designed for local application Ruxolitinib cream is currently in phase III clinical development: (1) for the treatment of mild to moderate atopic dermatitis (true-ad project) patients, (2) for the treatment of juvenile and adult vitiligo (true-v project) Incyte has the global right to develop and commercialize ruxolitinib cream In October 2019, Incyte released 52 week data of phase II study of ruxolitinib cream in the treatment of vitiligo Previously, the study had reached the primary end point: after 24 weeks of treatment, there was a significantly higher proportion of patients in the ruxolitinib cream group compared to the vehicle control (non drug cream) group with a face vitiligo severity index score improved by ≥ 50% from baseline (f-vasi50) The latest results of the 52nd week showed that: the proportion of patients whose total vitiligo area severity index improved by ≥ 50% (t-vasi50) compared with the baseline was evaluated, and compared with the vehicle for photography, ruxolitinib cream had significant improvement on the whole body vitiligo skin color restoration, reaching a key secondary end point of the study In addition, after 52 weeks of treatment with 1.5% ruxolitinib cream twice a day (bid), 58% of the patients achieved f-vasi50 and 51% achieved 75% improvement (f-vasi75) Ruxolitinib is the active drug component of oral drug jakafi of Incyte company, which has been approved for three indications in the United States: (1) treatment of adult patients with erythrocytosis (PV) who are insufficiently or intolerant to thioglycosuria; (2) treatment of adult patients with high-risk myelofibrosis (MF), including primary MF, MF after PV, MF after primary thrombocytosis; (3) treatment of solid Patients with alcohol refractory acute graft versus host disease (GVHD) Among them, the third indication was approved by FDA in May 2019, which is the first drug approved to treat the indications Jakafi is sold in the United States by Incyte and Novartis is sold under the name of jakavi in markets outside the United States At present, concert is also developing ctp-543, a ruxolitinib molecule modified by deuterium chemical technology In phase II clinical research, it has shown strong efficacy in the treatment of alopecia areata Alopecia areata is an autoimmune disease that causes local or complete hair loss The deuterium chemical modification of ruxolitinib can change the pharmacokinetics of ruxolitinib in human body, so as to enhance its application in the treatment of alopecia areata In the United States, the FDA has granted ctp-543 a fast track status for the treatment of alopecia areata Origin of the original text: encyte announcements that the troue-ad2 pivotal trial of ruxolitinib cream met its primary endpoint in patients with atopic dermatis