Concorde Kirin pioneered the clinical success of ox40-targeted single-anti-KHK4083 Phase II

Japanese pharmaceutical company Kyowa Kirin recently announced that phase 2 studies evaluating the antibody drug KHK4083 for moderate to severe specific dermatitis (AD) adult patients have reached the main endpoint.KHK4083 is a potential first-in-class anti-OX40 all-human monoclonal antibody that is currently being developed for the treatment of autoimmune diseases, including specific dermatitis (AD). KHK4083 was discovered by Concord Kirin and produced using the company's patented POTELLIGENT® deyan algae glycosylation (defucosylation) technology to enhance its antibody-dependent cytotoxicity (ADCC) activity. The joint action of ADCC and OX40 antagonists may inhibit the inflammatory response, which is the cause of endemic dermatitis.OX40 is a co-stimulating molecule that is a super-family member of tumor necrotic necrotum (TNFR) and playes an important role in maintaining T-cell proliferation and survival, and memory T-cell formation. OX40 is expressed on the surface of the effect T cell (CD4-positive) activated by the antigen. It has been reported that the effect T cells expressing OX40 are present in the dermatitis of the specialty dermatitis.The Phase 2 study, a multi-center, randomized, double-blind and placebo-controlled clinical study in Japan, the United States, Canada and Germany, looked at the efficacy and safety of KHK4083. A total of 274 patients with moderate to severe specific dermatitis who received topical medication but failed to adequately control their condition were included in the study.In the study, all KHK4083 queues reached the primary endpoint: statistically significant in terms of the percentage change in eczema area and severity index (EASI) relative to baseline in the treatment week 16. In addition, all KHK4083 queues differed significantly from the placebo queue in terms of "proportion of patients who reached EASI-75 at week 16 (EASI score improved 75% or more from baseline)" and "patients who achieved a researcher's overall assessment (IGA≥ score of 0 or 1 at week 16 and improved by baseline≥ After the 16th week, further improvements in the efficacy of KHK4083 were observed. Adverse events (TEAEs) during the common treatment of KHK4083 queues are fever, nasopharyngitis, exacerbation of endearing dermatitis, and chills in the first 16 weeks. Fever and chill events are mild to moderate in intensity, mostly due to injection reactions, and are observed only after the first dose of the experimental drug. Serious allergic reaction events and deaths were not observed in the study.The full results of the study will be presented at a future medical conference. Dr Emma Guttman Yassky, lead investigator of the study and chair of dermatology and immunology and professor of dermatology and immunology at the Icahn School of Medicine, said: "The results of the Phase 2 study at KHK4083 suggest that OX40 is a target for endemic dermatitis and may provide a new
treatment model. In addition to the main endpoints, this study also showed that after more than 16 weeks of continuous treatment with KHK4083, the efficacy increased, and after the completion of KHK4083 treatment, there is potential for long-term sustainable therapeutic effect. (
Valley
)original source: Kyowa Kirin Announces Positive Phase 2 Results for KHK4083 in Patients with Moderate to Severe Atopic Dermatitis