The first participant in a phase 1b/2a study (NCT04227470) has received a first dose of batoclimab (HBM9161, Harbour BioMed, Cambridge, MA)in a clinical trial for neuromyelitis optica spectrum disorder (NMOSD). This clinical study aims to assess the safety, tolerability, pharmacodynamics, and efficacy of batoclimab in individuals with NMOSD in China. It is the first antiFcRn PoC study for the treatment of NMOSD.
Batoclimab is a fully human monoclonal antibody targeting the neonatal Fc receptor (FcRn) that accelerates the degradation of autoantibodies that drive NMOSD as well as other autoimmune disorders. Based on its novel mechanism and high unmet need in China, clinical trials for other autoimmune diseases, including myasthenia gravis, Grave's ophthalmopathy, and neuromyelitis optica spectrum disorder will also begin this year.
"With the COVID-19 situation gradually easing in China, we are happy to have successfully achieved the milestone of dosing the first patient. NMOSD is a serious autoimmune disease of the central nervous system with no approved effective treatment. The initial clinical studies, including our phase 1 trial, demonstrating that batoclimab has an excellent safety profile and potent IgG reduction capability. We believe this novel mechanism will bring an effective therapeutic to the patients," said Dr. Jingsong Wang, founder, chairman, and CEO of Harbour BioMed.
Batoclimab is being developed as a pipeline in a product to treat multiple pathogenic-IgG mediated autoimmune diseases with significant unmet medical needs. The NMOSD is among the first indications being developing in China.