On February 18, 2021, specialty pharmaceutical company Kyowa Kirin Co., Ltd. (“Kyowa Kirin”) shared that a Phase 2 clinical trial evaluating KHK4083 had reached its primary endpoint. KHK4083 is an investigational therapy designed to treat patients with moderate-to-severe atopic dermatitis.
So what is KHK4083? This anti-OX40 fully human monoclonal antibody is designed to treat patients with a variety of autoimmune disorders. According to the American Cancer Society, a monoclonal antibody is a laboratory- or man-made protein designed to mimic antibodies within our immune system. Meanwhile, OX-40 is part of the tumor necrosis factor receptor (TNFR) family, which means it helps with T cell proliferation and growth. Since certain effector T cells in atopic dermatitis express OX40, targeting this can reduce symptoms. So KHK4083 works by inhibiting OX40 and suppressing inflammation. Kyowa Kirin discovered and developed KHK4083 using its proprietary POTELLIGENT defucosylation technology.
During the study, researchers evaluated patients with moderate to severe atopic dermatitis from four countries. Altogether, 274 patients enrolled. The primary endpoint examined the change from baseline in the Eczema Area and Severity Index (EASI) after a 16-week (4~ month) period. Throughout the study, a significant portion of patients improved their EASI scores by 75%. Additionally, KHK4083 showed continuous and sustained response following the 16-week period. This suggests that KHK4083 could significantly improve patients’ quality of life (QOL).
While the treatment was safe and well-tolerated, some adverse reactions did occur. These include:
- Common cold
- Worsening atopic dermatitis
Severe Atopic Dermatitis
Genetic and environmental factors cause severe atopic dermatitis, or eczema, a chronic inflammatory condition causing itchy, dry, and inflamed skin. If the skin is scratched, it often begins to weep, resulting in further infections. An estimated 30% of Americans have severe atopic dermatitis. Typically, those with severe atopic dermatitis often have food allergies, hay fever, and other allergies. Triggers can worsen the symptoms. These triggers include living in a dry climate, certain fragrances or dyes, chemical irritation, stress, or dressing in rough materials. Symptoms usually appear within 6 months of birth. These include:
- Severe itching (pruritus)
- Dry, red, or scaly skin
- Sensitive and swollen skin (after scratching)
- Thickened or cracked skin
Learn more about severe atopic dermatitis.