Core Viewpoint - The company has successfully completed the first cohort of a bridging study for the subcutaneous formulation of SM17, demonstrating good tolerability and no reported adverse events among healthy subjects, indicating a positive outlook for the drug's safety and efficacy in treating atopic dermatitis (AD) [1][3]. Group 1: Clinical Trial Progress - The bridging study for SM17 aims to assess the drug's safety, tolerability, and pharmacokinetic characteristics, with a total of 30 healthy subjects planned for enrollment by November 2025 and follow-up completion by March 2026 [1]. - The first phase clinical trial in the U.S. showed good safety and tolerability for SM17, with no serious drug-related adverse events reported [3]. - Positive topline results from the Phase 1b proof-of-concept study indicated that 91.7% of patients in the high-dose group achieved itch relief, and 75% reached skin lesion recovery, outperforming existing IL-4/IL-13 monoclonal antibodies [3]. Group 2: Drug Characteristics and Market Potential - SM17 is a novel humanized IgG4-κ monoclonal antibody targeting the IL-25 receptor, which plays a crucial role in type II allergic responses, potentially offering a safer and more effective treatment for AD [1][4]. - The subcutaneous formulation of SM17, developed in-house, boasts high protein stability, ease of injection, and low pain upon administration, with a pharmacokinetic bioavailability exceeding 90% in preclinical studies [2]. - There remains a significant market opportunity for AD therapies that can provide rapid itch relief, skin lesion recovery, and good safety profiles, as current treatments do not fully meet these clinical needs [2]. Group 3: Research Publications and Efficacy - Research results for SM17 have been published in reputable international journals, demonstrating its efficacy comparable to JAK1 inhibitors in animal models of AD [4]. - The clinical findings published in the journal "Allergy" and "Frontiers in Immunology" highlight SM17's excellent safety, tolerability, and pharmacokinetic performance in healthy subjects [4]. - The company believes that targeting upstream pathways of Th2 inflammatory cytokines, such as the IL-25 receptor, will have broad implications for skin inflammation, indicating SM17's significant potential in AD treatment [4].
中国抗体-B(03681)：SM17在中国的皮下注射剂型桥接实验完成首个队列健康受试者给药