China Antibody-B (03681) issued an announcement that on June 5, 2024, the 1b clinical trial of SM17 for the treatment of atopic dermatitis has successfully completed the first patient dosing in China. As of the date of this announcement, no adverse events have been reported. The purpose of this phase 1b study is to investigate the safety, tolerability, and pharmacokinetic characteristics of SM17 and to preliminarily verify the efficacy of SM17 for patients with atopic dermatitis.
Intelligent Finance and Economics APP News, China Antibody-B (03681) announced that the 1b clinical trial of SM17 for the treatment of atopic dermatitis has successfully completed the first patient dosing in China on June 5, 2024. As of the date of this announcement, no adverse events have been reported. The purpose of this phase 1b study is to investigate the safety, tolerability, and pharmacokinetic characteristics of SM17 and to preliminarily verify the efficacy of SM17 for patients with atopic dermatitis.
SM17 is a novel, global first-in-class humanized IgG4-κ monoclonal antibody that can regulate the type II allergic reaction pathway by targeting the key molecule human interleukin-25 (IL-25) receptor mediated through the "alarmin" pathway. SM17 inhibits the binding of IL-25 to the receptor (IL-17RB) on type 2 innate lymphoid cells (ILC2s) and type 2 helper T cells (Th2), inducing a series of reactions, thereby inhibiting downstream signaling pathways such as Th2-type white interleukin IL-4, IL-5 and IL-13.
IL-25 is a class of key "alarmins" that have been shown to be associated with the pathological changes of autoimmune and inflammatory skin diseases such as atopic dermatitis. Atopic dermatitis patients have an increased overall and cause-specific mortality rate for diseases such as infection, respiratory, gastrointestinal, and neoplastic diseases. At present, approved therapies for atopic dermatitis (including biologics) can significantly improve the patient's eczema area and severity index as well as quality of life. However, there are still unmet medical needs for patients who do not respond to approved therapies.
The Company conducted a Phase I first-in-human clinical trial (NCT 05332834) in the United States to evaluate the safety and tolerability of SM17 in healthy subjects. The clinical report was obtained in the first quarter of 2024, which showed that SM17 has good safety and no serious adverse drug reactions have been reported. In order to conduct clinical research in China, the Company also conducted a Phase 1a bridging study in China, which demonstrated that SM17 exhibited similar and comparable safety between the U.S. and Chinese populations. In order to verify the preclinical research results published in the international scientific journal Allergy, proving that SM17 has the same efficacy in treating atopic dermatitis in mice as JAK1 inhibitors, it is very important to carry out a phase 1b concept validation study as evidence.
The Company believes that upstream therapies targeting Th2 inflammatory cytokine pathways (such as IL-25 receptors) will have a broad impact on skin inflammation, meaning that SM17 has enormous potential for safer and more effective treatment of atopic dermatitis with differentiation advantages.