Special dermatitis (AD) innovative therapy! Concorde Kirin pioneered THEX40 targeted single anti-KHK4083 Phase II clinical success!

February 19, 2021 // -- Kyowa Kirin, a Japanese pharmaceutical company, recently announced that phase 2 studies evaluating the antibody drug KHK4083 to treat adult patients with moderate to severe endexual dermatitis (AD) have reached the main endpoint.
KHK4083 is a potential first-in-class anti-OX40 all-human monoclonal antibody that is being developed to treat autoimmune diseases, including adesthetic 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.
ADCC and OX40 antagonists may inhibit the inflammatory response, which is the cause of endemic dermatitis.
ox40 is a co-stimulating molecule, a super-family member of tumor necrotic cells (TNFR), which play 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.
specialty dermatitis (Photo: icresearch.net) This Phase 2 study is a multi-center, randomized, double-blind and placebo-controlled clinical study conducted in Japan, the United States, Canada and Germany to investigate the efficacy and safety of KHK4083.
study included 274 patients with moderate to severe specific dermatitis who received topical medication but failed to adequately control their condition.
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, there was a significant difference between all KHK4083 queues with a "proportion of patients who reached EASI-75 at week 16 (THE EASI score was 75% or greater than the baseline)" and "the percentage of patients who reached the researcher's overall assessment (IGA) score of 0 or 1 at week 16 and improved by ≥2≥ compared to the baseline."
16 weeks of the khK4083, further improvements were observed.
(TEAE) that occur during common treatment in the KHK4083 queue are fever, nasopharyngitis, worsening of endearing dermatitis, and chills in the first 16 weeks.
intensity of fever and chill events was mild to moderate, mostly due to injection reactions, and were observed only after the first dose of the experimental drug.
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 on the study and chair of the dermatology and immunology department at Icahn Medical School and professor of dermatology and immunology, said: "The results of phase 2 of 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 showed an increase in efficacy, and after the completion of KHK4083 treatment, there is a potential for long-term sustainable therapeutic effect.
":Kyowa Kirin Announces Positive Phase 2 Results for KHK4083 in Patients with Moderate to Severe Atopic Dermatitis