SinoMab Secures Approval for SM17 Clinical Trials in China
Hong Kong-based SinoMab BioScience Limited announced that China's NMPA has approved its Investigational New Drug (IND) application for SM17, a treatment candidate for atopic dermatitis. Phase I trials are planned for Q4 2023.
SinoMab BioScience Limited, a biopharmaceutical company focused on immunological diseases, has received approval from China's National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application for SM17. This drug candidate is intended for the treatment of patients with atopic dermatitis (AD).
The company plans to initiate a Phase I clinical study in China during the fourth quarter of this year. This study will investigate the safety profile of SM17 in the Chinese population. Additionally, SinoMab will commence the clinical development program for SM17 targeting allergic diseases.
SM17 is described as a first-in-class humanized IgG4-k monoclonal antibody. It targets the receptor for interleukin 25 (IL-25), a cytokine implicated in the pathogenesis of inflammatory skin diseases like AD. By blocking the IL-25 pathway, SM17 aims to suppress Type II allergic reactions. The unmet medical need for effective AD treatments is significant, particularly as the disease prevalence grows in China.
SinoMab has advanced SM17's development across multiple fronts. A Phase I study in the United States is nearing completion with no reported serious drug-related adverse events to date, indicating a favorable safety profile. Separately, an IND application for SM17 targeting asthma was also previously approved by the NMPA in China.