Hong Kong-based biotechnology company SinoMab BioScience Ltd (HKG: 3681) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study in China, assessing the safety of SM17, a first-in-class drug for atopic dermatitis (AD). The study is set to commence in the fourth quarter of this year.
Mechanism of Action and Targeting IL-25 Pathways
SM17 is designed to suppress Th2 immune responses by binding to IL-17RB on Type 2 Innate Lymphoid cells (ILC2s), effectively blocking the cascade of responses triggered by interleukin-25 (IL-25). IL-25, a critical cytokine known as an “alarmin,” has been implicated in the pathogenesis of airway viral responses and allergic diseases, making SM17 a potentially groundbreaking treatment for AD.
US Phase I Study Progress and Safety Profile
The Phase I study for SM17 in the US is nearing completion, with the last patient last visit (LPLV) expected in the coming month. To date, no serious adverse events have been reported, and the drug has demonstrated good tolerability and safety in human trials. These positive safety results from the US study, along with the NMPA’s approval, position SM17 as a promising candidate for further clinical development in China.-Fineline Info & Tech
