Harbour BioMed (HKG: 2142), a biotech company operating out of the United States, the Netherlands, and Suzhou (China), has announced positive topline results from its phase III clinical trial of batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG). The pivotal clinical study, designed to confirm the efficacy and safety of batoclimab in patients with gMG in China, enrolled 132 subjects. The data from the phase III trial met the primary endpoint as well as key secondary endpoints, indicating the drug’s effectiveness in treating this autoimmune condition.
Safety and Tolerability
Batoclimab treatment was found to be overall safe and well-tolerated, with no new safety signals identified during the trial. This is a crucial aspect of the drug’s profile, as it suggests that batoclimab can be a viable treatment option for patients suffering from gMG, without introducing significant new risks.
Understanding Myasthenia Gravis
Myasthenia gravis (MG) is an acquired autoimmune disease mediated by antibodies such as anti-acetylcholine receptor (AChR) immunoglobulin G (IgG) antibody and anti-muscle-specific tyrosine kinase (Anti-MuSK) IgG. The disease involves the postsynaptic membrane of the neuromuscular junction, causing impaired transmission and presenting with skeletal muscle contraction weakness. Patients often exhibit ocular muscle manifestations, and approximately 85% of patients will show symptoms beyond ocular muscles, developing generalized myasthenia gravis (gMG). In severe cases, patients may experience myasthenic crisis.
Mechanism of Batoclimab (HBM9161)
Batoclimab (HBM9161) is a fully human anti-FcRn monoclonal antibody (mAb) that blocks FcRn-IgG interactions, accelerating the degradation of autoantibodies. This mechanism leads to the treatment of pathogenic IgG-mediated autoimmune diseases, including gMG. A Phase II study in myasthenia gravis demonstrated that batoclimab can quickly and significantly alleviate symptoms and improve the quality of life for patients. Earlier studies have also shown that batoclimab is well tolerated and can rapidly reduce total IgG in a wide array of pathogenic IgG-mediated autoimmune diseases.
Licensing Deal
In October 2022, CSPC Pharmaceutical Group Co., Ltd’s (HK.01093) wholly-owned subsidiary Shijiazhuang Pharma Group NBP Pharmaceutical (Shijiazhuang) Co. Ltd struck an RMB 1 billion (USD 144 million) licensing deal with Harbour BioMed. This deal granted Shijiazhuang Pharma Group NBP Pharmaceutical exclusive development, manufacturing, and commercialization rights to batoclimab in Greater China, highlighting the potential market for this innovative treatment in the region.-Fineline Info & Tech
