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Bio-Thera Solutions Publishes Phase I Clinical Study Results for BAT4406F

Bio-Thera Solutions, a biopharmaceutical company based in Guangzhou, China, has released its findings from a Phase I clinical trial concerning BAT4406F, a fully humanized anti-CD20 monoclonal antibody. This antibody is specifically designed to enhance immune response through antibody-dependent cellular cytotoxicity (ADCC). The results were published in the journal CNS Neuroscience Therapeutics on January 14, 2025.

Understanding Neuromyelitis Optica Spectrum Disorder (NMOSD)

Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune condition that leads to severe inflammation of the brain and spinal cord, often resulting in debilitating symptoms such as optic neuritis and transverse myelitis. These symptoms can lead to visual impairment, paralysis, and loss of bladder control, creating a pressing need for effective treatment options.

Currently treated with B-cell depletion therapy utilizing monoclonal antibodies against CD20, NMOSD management aims to decrease disease recurrence and slow the progression of neurological decline.

Study Overview

The Phase I clinical study aimed to ascertain the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and immunogenicity of BAT4406F administered to Chinese patients diagnosed with NMOSD (ClinicalTrials.gov identifier NCT04146285). The trial involved 15 participants across five dose groups ranging from 20 mg to 750 mg.

Patients received a single intravenous infusion of BAT4406F and were monitored for six months. Findings revealed no dose-limiting toxicities (DLT), along with mostly mild adverse events categorized as CTCAE Grade 1 or 2, indicating a favorable safety profile. Noteworthy, there were no serious adverse reactions reported.

Observations indicated that the PK profile of BAT4406F displayed nonlinear characteristics. As dosage increased, parameters such as maximum concentration (Cmax) and area under the curve (AUC) exhibited an upward trend while clearance (CL), volume of distribution (Vd), and half-life decreased.

All dose groups demonstrated a significant and rapid depletion of B-cells, a critical factor in managing NMOSD. Furthermore, during the six-month follow-up, approximately 86.7% of the subjects remained relapse-free.

Efficacy and Future Directions

The assessment of expanded disability status scale (EDSS) scores indicated improved outcomes for participants receiving higher doses of BAT4406F, with marked decreases compared to baseline measurements.

Though three subjects tested positive for anti-drug antibodies (ADA), it is crucial to note that no detrimental effects on the PK, safety, pharmacodynamics, or efficacy were observed, pointing towards the favorable profile of BAT4406F as a potential treatment for NMOSD.

Following this promising Phase I study, Bio-Thera Solutions plans to advance into a Phase II/III multicenter, randomized, double-blind, placebo-controlled trial for BAT4406F in Chinese NMOSD patients under ClinicalTrials.gov identifier NCT06044350.

About Bio-Thera Solutions

Bio-Thera Solutions is at the forefront of biopharmaceutical innovation, focusing on novel therapeutics for conditions like cancer, autoimmune disorders, and other severe medical needs. The company prides itself on its capabilities in antibody discovery and engineering, with several candidates progressing through various stages of clinical development. For more details, visit Bio-Thera’s official website.

Cautionary Note

Readers are reminded that forward-looking statements involve inherent risks and uncertainties that could result in significant variations from projected results. Bio-Thera does not commit to public updates unless mandated by law.

Conclusion

The Phase I clinical trial of BAT4406F demonstrates potential as a viable treatment option for NMOSD with an impressive safety profile and preliminary efficacy findings. As research continues, this innovative therapy may offer renewed hope for individuals with this challenging condition.