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.
Source: Company Press Release