CAMBRIDGE, Mass. & ROTTERDAM, The Netherlands & SUZHOU, China--(BUSINESS WIRE)--Harbour BioMed (HBM) today announced completion of a Phase 1 study of HBM9161, a fully human anti-FcRn monoclonal antibody, to evaluate its safety, tolerability, pharmacokinetics and pharmacodynamics in healthy Chinese subjects. The results demonstrated an excellent safety profile and potent IgG reduction capability. The full study will be presented at an upcoming international conference.
Based on the results of the study, and data generated by its global partner, HBM plans to begin clinical trials this year in several autoimmune diseases, including adult immune thrombocytopenia, myasthenia gravis, Grave’s ophthalmopathy, and neuromyelitis optica spectrum disorder.
“There are high unmet medical needs in China for a spectrum of pathogenic-IgG mediated autoimmune diseases. With its novel mechanism and outstanding safety profile, HBM9161 has the potential to treat numerous debilitating conditions,” said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. “We are working with the clinical community to advance its development as the first-in-class molecule in China in multiple autoimmune diseases and expect to develop a portfolio-in-a-product with this exciting molecule.”
HBM9161 is a fully human monoclonal antibody targeting the neonatal Fc receptor (FcRn) that accelerates the degradation of autoantibodies that drive a wide array of autoimmune disorders. The randomized, placebo-controlled, single ascending dose study was conducted at the University of Hong Kong’s Phase 1 Clinical Trial Center, with Desmond Y.H. Yap as the principal investigator. A total of 24 healthy subjects were enrolled and randomized into three cohorts, with a 6:2 ratio of treatment vs. placebo. Subjects were given a subcutaneous dose of HBM9161 (340 mg/510mg/680 mg) and then followed up for 85 days. The pharmacokinetic profile and IgG reductions observed in this study were consistent with previous studies conducted by HanAll in a Canadian population with the same molecule. Furthermore, the safety profile, including mild to moderate adverse events, was similar to those observed in the previous study. The data confirms HBM9161’s safety and supports further investigation of its efficacy and safety in IgG-mediated autoimmune disorders.
FcRn plays a pivotal role in preventing the degradation of IgG antibodies. The physiologic function of FcRn is to modulate the catabolism of IgG antibodies, and inhibition of FcRn, such as through use of an FcRn targeting antibody, has been shown to reduce levels of pathogenic IgG antibodies. HBM9161 is a fully human monoclonal antibody targeting the FcRn receptor. Blocking the FcRn-IgG interaction may alleviate flare-ups in a wide array of pathogenic IgG-mediated autoimmune diseases, including myasthenia gravis, Grave’s ophthalmopathy, neuromyelitis optica spectrum disorder and immune thrombocytopenia, amongst others.
HBM licensed HBM9161 from HanAll Biopharma and has the right to develop, manufacture and commercialize the product in Greater China (including Hong Kong, Macau and Taiwan).
About Harbour BioMed
Harbour BioMed is a global, clinical stage biopharmaceutical company developing innovative therapeutics in the fields of immuno-oncology and inflammatory diseases. The company is building its proprietary pipeline through internal R&D programs, collaborations with co-discovery and co-development partners and select acquisitions.
The company's internal discovery programs are centered around its two patented transgenic mouse platforms for generating fully human monoclonal antibodies. Harbour BioMed also licenses the platforms to companies and academic institutions. The company has operations in Cambridge, Massachusetts; Rotterdam, The Netherlands; and Suzhou & Shanghai, China. For more information, visit www.harbourbiomed.com.