New drug for atopic dermatitis! The phase III project of Incyte's Jak1 / 2 inhibitor ruxolitinib cream was successful!

February 21, 2020 / biool / -- Incyte recently announced that the second randomized, excipient controlled, critical phase III study (nct03745638) of ruxolitinib cream in the treatment of adolescent and adult (age ≥ 12 years) atopic dermatitis (AD) patients with stage III true-ad clinical trial has reached the main end point Ruxolitinib cream was developed for the treatment of (1) mild to moderate atopic dermatitis (true-ad project); and (2) juvenile and adult vitiligo (true-v project) In the treatment of vitiligo, the previously published data showed that: compared with the excipient control group (cream without drugs), the ruxolitinib cream treatment group patients' facial vitiligo severity index score significantly improved, and the whole body vitiligo skin discoloration significantly improved In January this year, Incyte published the positive top line results of the first critical phase III study of true-ad2 (nct03745651) in the treatment of atopic dermatitis with ruxolitinib cream Results from the true-ad1 study also showed that 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 compared to patients receiving excipients, defined as IgA scores of 0 (complete removal of lesions) or 1 (almost complete removal of 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 True-ad1 and true-ad2 are two clinical trials of the same design A total of 1250 patients were enrolled in the study The safety and efficacy of ruxolitinib cream in the treatment of mild to moderate atopic dermatitis (AD) in adolescents and adults (age ≥ 12 years) were evaluated The key efficacy outcomes were as follows: the true AD1 study: Compared with the excipient group, a higher proportion of patients in the 0.75% cream group and 1.5% cream group achieved the success of iga-ts treatment (50.0% and 53.8% respectively in the 0.75% group and 1.5% group, and 15.1% respectively in the excipient group, P < 0.0001), and a higher proportion of patients achieved easi75 (improvement of eczema area and severity index score ≥ 75% compared with the baseline level: 56% and 62.1% in the 0.75% group and 1.5% group, respectively), and the shape forming group The dosage group was 24.6%, P < 0.0001) ——True ad2 study: Compared with the excipient group, a higher proportion of patients in the 0.75% cream group and 1.5% cream group achieved the success of iga-ts treatment (39.0% and 51.3% respectively in the 0.75% group and 1.5% group, and 7.6% respectively in the excipient group, P < 0.0001) A higher proportion of patients achieved easi75 (improvement of eczema area and severity index score from the baseline level ≥ 75%: 51.5% and 61.8% respectively in the 0.75% group and 1.5% group, respectively) The dosage group was 14.4%, P < 0.0001) ——Two studies: in terms of pruritus reduction measured by nrs4, there was a statistically significant difference between the two cream treatment groups and the excipient group After 8 weeks of treatment, the overall incidence of adverse events (teae) and the incidence of serious adverse events were comparable between the two groups A long-term safety assessment of the 44 week extension of these two studies is currently under way Jim Lee, M.D., vice president of inflammation and autoimmunity, Incyte, said: "the successful results of the study of true-ad1 and true-ad2 confirm the potential of ruxolitinib cream as an important non steroidal treatment for patients with millions of AD We look forward to working with regulators to approve ruxolitinib cream as the first external JAK inhibitor for AD patients as soon as possible " 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 Original source: incoming announcements positive topline results from phase 3 true ad program evaluating ruxolitinib cream in patients with atopic dermatis