Bio-Thera Solutions Publishes Phase I Clinical Study Results for BAT4406F, an ADCC-Enhanced Fully Humanized Anti-CD20 Monoclonal Antibody, in Patients with Neuromyelitis Optica Spectrum Disorders

Bio-Thera Solutions, a leading biopharmaceutical company based in China, has recently published the results of a Phase I clinical study for BAT4406F, an ADCC-enhanced fully humanized anti-CD20 monoclonal antibody, in patients with Neuromyelitis Optica Spectrum Disorders (NMOSD). The study, titled "First-in-Human Study of BAT4406F, an ADCC-Enhanced Fully Humanized Anti-CD20 Monoclonal Antibody in Patients with Neuromyelitis Optica Spectrum Disorders (NMOSD)," was published in the journal CNS Neuroscience & Therapeutics.

BAT4406F is an innovative drug developed by Bio-Thera Solutions for the treatment of NMOSD, a rare and debilitating autoimmune disease that affects the central nervous system. The drug is designed to target and bind to CD20, a protein found on the surface of B cells and their precursors, leading to their clearance through ADCC (Antibody-Dependent Cell-Mediated Cytotoxicity) and CDC (Complement-Dependent Cytotoxicity) mechanisms. This targeted approach aims to reduce the number of B cells in the body, which are believed to play a crucial role in the pathogenesis of NMOSD.

The Phase I clinical study was conducted in China and involved 15 patients with NMOSD. The primary objectives of the study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BAT4406F in these patients. The study also aimed to investigate the immunogenicity and preliminary efficacy of the drug in this population.

The results of the study demonstrated that BAT4406F was well-tolerated, with no dose-limiting toxicities (DLTs) observed in the study. Only one severe adverse event (SAE) was reported, which was deemed possibly unrelated to the study drug. The drug exhibited non-linear PK characteristics, with an increase in Cmax, AUC0-t, and AUC0-inf as the dose increased, and a decrease in CL and Vd. The T1/2 ranged from 9.0 to 16.4 days, indicating a relatively long half-life for the drug.

BAT4406F showed significant B-cell depletion and maintained B-cell levels at a lower level for a certain period. The duration of B-cell depletion was dose-dependent, with higher doses resulting in longer depletion times. In the observation period, 13 out of 15 (86.7%) patients completed the trial, and 2 patients experienced relapses. By the 180th day, the extended disability status scale (EDSS) mean values had decreased from baseline in the 100mg, 500mg, and 750mg groups. No significant impact of anti-drug antibodies (ADAs) on PK, safety, drug efficacy, or clinical outcomes was observed.

The publication of these results marks an important milestone for Bio-Thera Solutions and the development of BAT4406F. The drug has shown promising safety and efficacy in the treatment of NMOSD, and further clinical studies are planned to confirm these findings and compare the efficacy of BAT4406F to other anti-CD20 therapies in treating NMOSD.



In conclusion, the Phase I clinical study of BAT4406F in patients with NMOSD has demonstrated the drug's potential as a safe and effective treatment option for this debilitating autoimmune disease. The results of this study pave the way for further clinical development and evaluation of BAT4406F in the treatment of NMOSD.