Bio-Thera Solutions has announced the early termination of its pivotal Phase II/III clinical trial of BAT4406F for neuromyelitis optica spectrum disorder (NMOSD).
The move follows a recommendation from the Independent Data Monitoring Committee (IDMC), which comes after a positive interim analysis, prompting the company to cease patient enrolment ahead of schedule.
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BAT4406F comprises an antibody-dependent cellular cytotoxicity (ADCC)-enhanced, fully humanised anti-CD20 monoclonal antibody.
Its formal review concluded that the therapy met the pre-defined superiority criteria, showing significant efficacy. It has also maintained a favourable safety profile.
Carried out across 45 sites in China, the double-blind, randomised, placebo-controlled trial was spearheaded by Professor Chen Xiangjun at Huashan Hospital, Fudan University.
Bio-Thera will now prepare to file for regulatory approval from the National Medical Products Administration (NMPA). The company is also planning to investigate the efficacy and safety of the therapy in other indications.
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By GlobalDataMarked by progressive disability and high relapse rates, NMOSD is a rare, severe autoimmune condition that mainly affects the spinal cord and optic nerves, resulting in outcomes such as rapid vision loss and paralysis.
This condition was included in the country’s First National Rare Disease Catalog in 2018 by the National Health Commission, highlighting the significant disease load on individuals.
Existing treatment alternatives are limited, underscoring the importance of developing new therapies.
The company focuses on developing therapeutics for various severe medical conditions, including cancer, cardiovascular, autoimmune, and eye diseases.
It also creates biosimilars for current branded biologics to treat a variety of cancer and autoimmune conditions.
Last month, the company initiated dosing in the randomised Phase III trial of the antibody-drug conjugate (ADC), BAT8006, aimed at treating platinum-resistant ovarian cancer (PROC).
