Akeso Rapidly Advances Phase II Clinical Trial of IL-4R Monoclonal Antibody (AK120) for Treatment of Atopic Dermatitis and Asthma


Posted: October 14, 2021 at 10:44 p.m. MDT|Update: 11 hours ago

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

At the same time, the first patient recruitment for the global phase II clinical trial of AK120 for the treatment of moderate to severe atopic dermatitis in the first research center of United States is over and the trial is progressing rapidly.

IL-4 and IL-13 are two critical factors for the initiation of type II inflammation. AK120 can bind specifically to IL-4R, which competes with IL-4 and IL-13 by binding to IL-4Rα, and thus blocks the signal transduction pathway by downstream, and achieves the goal 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 multidose escalation phase Ib clinical trial for the treatment of AK120 atopic dermatitis were completed in New Zealand and Australia. Based on 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, the first clinical trials have shown that AK120 has a potential clinical efficacy comparable or superior to that of dupilumab in patients with atopic dermatitis. According to preclinical pharmacodynamics, AK120 is better in terms of pharmacogability with regard to asthma. It can greatly reduce the levels of leukocytes, eosinophilic granulocytes and the level of peripheral blood specific immunoglobulin E (IgE) antibody in the alveolar lavage fluid of the 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 an advanced stage of clinical development, AK120 is expected to bring hope to atopic disease patients with type II inflammation as the primary pathogenesis in China in the near future, and would fill the void of clinical needs in China.

The IL-4R monoclonal antibody is considered an important target for the treatment of allergic diseases and is currently one of the best-selling antibody protein drugs for autoimmune diseases. According to publicly available data, with the increasing penetration rate of IL-4R-targeted drugs, sales in the global IL-4R antibody drugs market are expected to reach approximately US $ 12.2 billion by 2024, where China market will represent approximately $ 607 million. Currently, dupilumab is the only IL-4R monoclonal antibody approved for marketing worldwide, and global sales of this drug have exceeded US $ 4 billion in 2020.

Information about AK120 (IL-4R monoclonal antibody)

AK120 is a new drug targeting IL-4R for treatment autoimmune diseases independently developed by the Company. AK120 is intended for use in the treatment of atopic dermatitis, asthma, and other allergic diseases. AK120 clinically treats allergic autoimmune diseases by blocking the biological activities of the double cytokines IL-4 and IL-13.

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SOURCE Akeso, Inc.

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