(HONG KONG, 27 Sept 2021) Akeso, Inc. (the Company, 9926.HK) announces that the Company’s self-developed innovative drug candidate, IL-4Rα monoclonal antibody (AK120), initiated a global phase II clinical study for the treatment of moderate-to-severe atopic dermatitis which was approved by the Food and Drug Administration of the United States (the FDA).
This is a multi-center, randomized, double-blind, placebo-controlled, parallel, dosage exploration phase II clinical trial to evaluate the efficacy and safety of AK120 in adult subjects with moderate-to-severe atopic dermatitis.
Previously, AK120 has completed a single dose escalation phase Ia clinical trial in healthy subjects and a multi-dose escalation phase Ib clinical trial for the treatment of atopic dermatitis in New Zealand and Australia. Based on the preliminary data obtained in the first- in-human (FIH) trial, AK120 was safe and well-tolerated when dosed subcutaneously in adult healthy subjects with a single dose level of up to 600 mg. For adult subjects with moderate-to-severe atopic dermatitis, AK120 also showed a good safety and tolerability profile with a weekly subcutaneous dose level of up to 300 mg.
Based on the preliminary efficacy data from the blinded phase Ib clinical trial, it was observed that the proportion of subjects with improvement fulfilling Eczema Area and Severity Index (EASI) 50, EASI 75 and Investigator’s Global Assessment (IGA) score clear (0) or almost clear (1), which showed good efficacy in each dosing regimen with better dose-dependence, indicating that the clinical efficacy of AK120 was promising. In the phase Ia clinical trial in healthy subjects and phase Ib clinical trial in subjects with atopic dermatitis, the reduction of two key factors associated with type II inflammation, namely thymus- and activation-regulated chemokine/CC chemokine ligand 17 (TARC/CCL17) and immunoglobulin E (IgE), also demonstrated good dose-dependence.
AK120 has demonstrated comparable or better potential efficacy in atopic dermatitis patients compared to dupilumab.
Currently, IL-4R is one of the best-selling antibody protein drugs for autoimmune disease. According to publicly available data, with the increasing penetration rate of IL-4R targeted drugs, it is expected that the global market sales of IL-4R antibody drugs will reach to approximately US$12.2 billion by 2024, in which China market will account for approximately US$607 million. At present, dupilumab is the only approved IL-4R monoclonal antibody for marketing in the world, and the global sales of this drug exceeded US$4 billion in 2020.
Information about AK120 (IL-4R Monoclonal Antibody)
AK120 is a novel drug targeting IL-4R of autoimmune treatment diseases independently developed by the Company. AK120 is intended to be used for the treatment of atopic dermatitis, asthma and other allergic diseases. AK120 clinically treats allergic autoimmune diseases by blocking the biological activities of dual cytokines IL-4 and IL-13.
Information about Akeso, Inc.
Akeso, Inc. is a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of new innovative antibody drugs that are affordable to patients worldwide. Since the Company’s establishment, the Company has established an end-to-end comprehensive drug development platform (ACE Platform) and system, encompassing fully integrated drug discovery and development functions, including target validation, antibody drug discovery and development, CMC production process development, and GMP compliant scale production. The Company has also successfully developed a bi-specific antibody drug development technology (Tetrabody technology). The Company currently has a pipeline of over 20 innovative drugs for the treatment of major diseases like tumors, autoimmune diseases, inflammation and metabolism diseases, 13 of which have entered clinical stage, including two first-in-class bi-specific antibody drugs (PD-1/CTLA-4 and PD-1/VEGF). In Aug 2021, the Company’s first in-house innovatively researched and developed differentiated PD-1 monoclonal antibody Penpulimab monoclonal antibody injection (安尼可®) was approved to the market. The Company’s vision is to become a global leading biopharmaceutical company through research and development of high efficacy and breakthrough new drugs that are first-in-class and best-in-class therapies.