HONG KONG, Apr 16, 2024 - (ACN Newswire) - SinoMab BioScience Limited (Stock Code: 3681.HK, “SinoMab” or the “Company”), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialisation of therapeutics for the treatment of immunological diseases, is pleased to announce that the preclinical works of SM17, a humanised IgG4 monoclonal antibody against IL-17RB, is published on Allergy, an official journal of the European Academy of Allergy and Clinical Immunology (EAACI), on 9 April, 2024. This article compared the efficacy of SM17 in alleviating symptoms of atopic dermatitis (AD) with that of FDA approved JAK1 inhibitor in a preclinical setting (animal data), and confirmed that animals treated with SM17 exhibited a similar, if not better, therapeutic responses than those treated with the FDA approved JAK1 inhibitor. The publication in this international, peer-reviewed and well-cited journal Allergy establishes the scientific validity of SM17 on the treatment of AD, and highlights the potential of SM17 as a revolutionary product in this field.

SM17 is a novel, first-in-class (FIC) IgG4 monoclonal antibody targeting IL-17RB (also known as interleukin 25 (IL-25) receptor) with the potential for treating atopic dermatitis, asthma, idiopathic pulmonary fibrosis and other immunological and autoimmune disorders. In Phase I clinical trials (NCT05332834) performed in the US, SM17 showed a good safety profile with no drug-related serious adverse event (SAE) reported, demonstrating superiority over other JAK1 inhibitor in safety and tolerability.

AD is a chronic inflammatory skin disease that is characterised by intense itching and recurrent blisters. AD patients are known to have low treatment satisfaction and there exists a huge unmet medical need for a safer and more efficacious treatment option. AD is driven by Th2 immunity where IL-25 is one of the key mediators that drives the whole cascade of events leading to ILC2 and Th2 cell activation, resulting in inflammatory skin swelling, itching, skin irritation and other symptoms characteristic of AD. The Company has developed SM17, a IgG4 monoclonal antibody, that targets a co-receptor for IL-25 (also known as IL-17RB), with the purpose of blocking the early (upstream) events induced by IL-25, in the hope of achieving a differentiating treatment modality for AD that is fast-acting, efficacious and safe. Current products in the market are either fast-acting and efficacious but with safety concerns (JAK1 inhibitor) or relatively slow to respond and less efficacious yet with better safety profile (anti-IL-4Ra antibody). The Allergy article and the results of the US Phase I study scientifically validated the favourable efficacies and good safety profile of SM17 for treating AD.

In addition to AD, SM17 is found to exhibit therapeutic potentials for treating asthma, idiopathic pulmonary fibrosis and other type 2 immunological disorders. Studies to explore the therapeutic potential of these indications are on-going.

Dr. Shui On LEUNG, Executive Director, Chairman and Chief Executive Officer of SinoMab said that: “SinoMab focuses on the development of innovative products through scientific excellence, with the goal of identifying differentiating products that address immunological diseases of unmet medical needs. We are pleased that evidence demonstrating the advantageous therapeutic potential of SM17 for treating AD is scientifically confirmed and endorsed by being published on the renowned peer-reviewed journal Allergy. The global market size for AD is estimated to reach US 27.68 billion by 2030, according to a new report by Grand View Research, Inc. Currently, the two most prescribed products for AD are the FDA approved anti-IL-4Ra antibody and JAK1 inhibitor. Studies indicated that JAK1 inhibitor is comparatively faster acting and achieving better response than anti-IL-4Ra antibody. However, JAK1 inhibitor has a black box warning, making anti-IL-4Ra antibody more receptive in the medical community due to its better safety profile. Our results indicated that SM17 appeared to have the best of both worlds: SM17 is comparable to (if not better than) JAK1 inhibitor in “time to response (anti-itching)”(unpublished data), and “therapeutic efficacies” in a preclinical model, as illustrated in the Allergy article, and comparable to (if not better than) anti-IL-4Ra antibody in tolerability and safety as demonstrated in our US Phase I study. SM17 is an innovative product with differentiating therapeutic and safety properties that compete favourably with existing treatment options. The preclinical results will be confirmed in human in a proof of concept clinical trial in AD patients that was initiated in April 2024.”

About SinoMab BioScience Limited

SinoMab BioScience Limited is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The R&D headquarters is located in Hong Kong and the production base is located in mainland China. The Company's flagship product SM03 (Suciraslimab) is a potential global first-in-class mAb against CD22 for the treatment of rheumatoid arthritis (RA) and has completed the Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), Alzheimer's disease, systemic lupus erythematosus (SLE), pemphigus, multiple sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD), asthma, and other diseases with major unmet clinical needs.

About Allergy

Allergy, the official journal of the European Academy of Allergy and Clinical Immunology (EAACI), aims to advance, impact and communicate all aspects of the discipline of Allergy/Immunology including educational, basic, translational and clinical research and maintain contact between basic and clinical Allergy/Immunology.

Allergy is an international journal with contributors and readers from all countries. Allergy publishes original articles, reviews, position papers, guidelines, editorials, news and commentaries, letters to the editors and correspondences.

For more information about SM17, please read the published article on Allergy.

Link http://doi.org/10.1111/all.16120

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