Harbour BioMed Announces Completion of Phase I Clinical Trial for Anti-FcRn Antibody HBM9161

VCBeat (WeChat ID: vcbeat) has learned that Harbour BioMed announced today the successful completion of the Phase I clinical study of HBM9161, a fully human anti-FcRn antibody. The study, conducted in healthy Chinese volunteers, aimed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HBM9161. The results demonstrated that HBM9161 exhibits a favorable safety profile and effectively reduces IgG levels. Harbour BioMed will present the study data at an international conference in the near future.

Based on the results of this clinical study and clinical trial data conducted by its partners, Harbour BioMed plans to initiate clinical studies targeting autoimmune diseases, including primary immune thrombocytopenia, myasthenia gravis, Graves’ ophthalmopathy, and neuromyelitis optica spectrum disorders, this year.

“There is a significant unmet clinical need in China for pathogenic IgG-mediated autoimmune diseases, and HBM9161, with its innovative mechanism of action and favorable safety profile, holds the potential to treat a range of autoimmune disorders caused by abnormal levels of pathogenic IgG,” said Dr. Wang Jinsong, Founder, Chairman, and CEO of Harbour BioMed. “We are actively collaborating with our clinical medicine colleagues to accelerate the clinical development of HBM9161 across several indications, striving to bring this much-needed innovative therapy to Chinese patients as soon as possible, while establishing this global first-in-class drug as a blockbuster product with a broad portfolio of indications.”

HBM9161 is a fully human antibody targeting the neonatal Fc receptor (FcRn) that accelerates the degradation of pathogenic IgG in vivo, with potential indications for multiple IgG-mediated autoimmune diseases. This Phase I clinical trial was a placebo-controlled, randomized, double-blind, single ascending-dose study conducted at the Phase I Clinical Research Centre of The University of Hong Kong, with Professor Desmond Y.H. Yap serving as the principal investigator. A total of 24 healthy volunteers were enrolled and randomly assigned to three groups of eight participants each. In each group, two participants received placebo and six received a single subcutaneous injection of HBM9161 at doses of 340 mg, 510 mg, or 680 mg, respectively. The post-dosing observation period lasted 85 days. The study results demonstrated that the pharmacokinetic profile and IgG-lowering pharmacodynamic effects of HBM9161 were consistent with those observed in clinical studies conducted by its partner in Canada. The safety profile was similar to that reported in previous studies, with only a few mild-to-moderate adverse events. These data further confirm the favorable safety profile of HBM9161, providing a foundation for future investigations into its clinical efficacy and safety in IgG-mediated autoimmune diseases.

HBM9161 is an antibody targeting the neonatal Fc receptor (FcRn). FcRn extends the half-life of IgG by reducing its lysosomal degradation. HBM9161 is a fully human antibody that targets FcRn and blocks the FcRn-IgG interaction to accelerate the degradation of autoantibodies, thereby treating various pathogenic IgG-mediated autoimmune diseases, such as myasthenia gravis, Graves' ophthalmopathy, neuromyelitis optica spectrum disorders, and primary immune thrombocytopenia.

HBM9161 is a first-in-class novel drug licensed by Harbour BioMed from HanAll Biopharma. Harbour BioMed holds the rights to develop, manufacture, and commercialize the product in the Greater China region (including Hong Kong, Macao, and Taiwan).

Harbour BioMed is a global, innovative biopharmaceutical company in the clinical development stage. The company focuses on the research and development of innovative drugs for oncology immunology and autoimmune diseases, leveraging its two fully human antibody transgenic mouse platforms (HarbourMice®), which are protected by global patents, to develop breakthrough innovative therapies for these conditions. Harbour BioMed also rapidly expands its new drug pipeline through diversified collaborations with business partners. Additionally, the company licenses its core technology platforms to other pharmaceutical companies and academic institutions worldwide. Harbour BioMed conducts global operations in multiple countries, including China, the United States, and the Netherlands.