Heplatin Pharmaceuticals announced that its fully human anti-FcRn antibody batolimab (HBM9161) has completed the first patient enrollment in the clinical phase 1b / 2a study of optic neuromyelitis spectrum diseases. This clinical study aims to evaluate the safety, tolerability, pharmacodynamics, and efficacy of batolimab (HBM9161) in patients with optic neuromyelitis spectrum diseases in China. This is also the world's first study of anti-FcRn target drugs in optic neuromyelitis lineage diseases.
Batoclimab (HBM9161) is a fully human antibody targeting neonatal Fc receptor (FcRn). It can accelerate the degradation of autoantibodies in patients with optic neuromyelitis spectrum diseases and other autoimmune diseases. Based on its innovative mechanism and the high unmet needs of autoimmune diseases in China, Heplatin Medicine will do its best to promote its autoimmunity including myasthenia gravis, thyroid eye disease, optic neuromyelitis spectrum diseases, adult immune thrombocytopenia Clinical development of sexual diseases.
Optic neuromyelitis (NMO) is an immune-mediated inflammatory demyelinating disease of the central nervous system that mainly involves the optic nerve and spinal cord. It is characterized by inflammatory demyelinating lesions in the spinal cord and optic nerve that can cause paralysis and blindness. Its main pathogenesis is due to the binding of pathogenic IgG to its target AQP4, and leads to complement-dependent cytotoxicity and secondary inflammation, accompanied by infiltration of granulocytes and macrophages, destruction of the blood-brain barrier and oligodendrocytes damage. In 2015, the International NMO Diagnostic Group (IPND) developed new diagnostic criteria for optic neuromyelitis lineage disease (NMOSD), canceled the separate definition of NMO, and integrated NMO into the broader NMOSD disease category.