HONG KONG, China I October 15, 2021 I Akeso, Inc. (the Company, 9926.HK) announces that the Company’s self-developed innovative drug candidate, IL-4R monoclonal antibody (AK120), was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of the People’s Republic of China to initiate a phase II clinical trial for the treatment of moderate-to-severe asthma.

Meanwhile, the first patient enrollment for the global phase II clinical trial of AK120 for the treatment of moderate-to-severe atopic dermatitis in the first research center in the United States has been completed and the trial is progressing rapidly.

IL-4 and IL-13 are two critical factors for initiating type II inflammation. AK120 can specifically bind to IL-4R, which competes with IL-4 and IL-13 in binding to IL-4Rα, and thereby blocks the downstream signal transduction pathway, and achieve the purpose of treating atopic diseases with type II inflammation as the main pathogenesis, such as atopic dermatitis, asthma and eosinophilic esophagitis.

In terms of safety, 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 of AK120 have been completed in New Zealand and Australia. Based on the preliminary data obtained in the trials, AK120 was safe and well-tolerated in healthy adult subjects (dose up to 600 mg, single dose) and subjects with atopic dermatitis (dose up to 300 mg once a week, multiple doses).

In terms of efficacy, early clinical trials have shown that AK120 has a potential clinical efficacy comparable to or better than that of dupilumab among patients with atopic dermatitis. According to the pre-clinical pharmacodynamics, AK120 is better in terms of druggability when it comes to asthma. It can significantly reduce the levels of leukocytes, eosinophilic granulocyte and the antibody level of peripheral blood specific immunoglobulin E (IgE) in the alveolar lavage fluid of asthma model.

Currently, there is still a lack of biologics with independent intellectual property rights for the treatment of moderate-to-severe asthma and moderate-to-severe atopic dermatitis approved in China, as well as great clinical needs. With the clinical trial of AK120 for atopic dermatitis and asthma advancing to late clinical development stage, AK120 is expected to bring hope for patients with atopic diseases with type II inflammation as the main pathogenesis in China in the near future, and would fill the gap of the clinical needs in China.

IL-4R monoclonal antibody is considered to be an important target for the treatment of allergic diseases, and is currently 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 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.