TG Therapeutics has initiated a Phase 2 trial of BRIUMVI (ublituximab-xiiy) in treatment-resistant schizophrenia to evaluate whether CD20-targeted B-cell depletion can improve symptoms in patients with persistent disease despite standard antipsychotic therapy.
Written By: Amit Kumar Bharati, BPharm
Reviewed By: Pharmacally Editorial Team
TG Therapeutics has initiated a Phase 2 clinical trial evaluating BRIUMVI® (ublituximab-xiiy) in adults with treatment-resistant schizophrenia, marking the company’s expansion beyond autoimmune neurology into psychiatric disease. The study will investigate whether B-cell depletion can improve clinical outcomes in patients who continue to experience significant symptoms despite receiving standard antipsychotic therapy.
Approximately 60 adults aged 18 to 60 years will be enrolled in the open-label, single-arm, multicenter trial. Participants will receive intravenous BRIUMVI while continuing their background antipsychotic treatment. The trial reflects increasing scientific interest in immune dysregulation and neuroinflammation as potential contributors to schizophrenia in a subset of patients.
Immune Dysfunction Emerges as a Potential Therapeutic Target
Schizophrenia is a chronic psychiatric disorder characterized by hallucinations, delusions, disorganized thinking, cognitive impairment, and impaired daily functioning. Although antipsychotic medications remain the cornerstone of treatment, many patients fail to achieve adequate symptom control, leaving a substantial unmet medical need.
Recent research has suggested that abnormal immune responses and neuroinflammatory pathways may contribute to disease progression in some patients. This hypothesis has gained support from early clinical observations, including preliminary findings with the anti-CD20 monoclonal antibody rituximab in a small cohort of patients with treatment-resistant schizophrenia. These findings have prompted further investigation of B-cell depletion as a novel therapeutic strategy.
BRIUMVI is a glycoengineered anti-CD20 monoclonal antibody that selectively targets CD20-expressing B cells. The antibody has been engineered to remove specific sugar molecules, enhancing antibody-dependent cellular cytotoxicity and enabling efficient B-cell depletion at relatively low doses. The therapy is currently approved in the United States for adults with relapsing forms of multiple sclerosis (RMS).
Study Will Evaluate Clinical Response at 12 Weeks
The Phase 2 study will assess both efficacy and safety of BRIUMVI in treatment-resistant schizophrenia. The primary endpoint is the proportion of participants achieving at least a 20% reduction from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 12, a widely accepted measure of clinical response in schizophrenia trials.
Secondary endpoints include additional efficacy assessments together with safety and tolerability evaluations. Because all participants will remain on their existing antipsychotic therapy, investigators will examine whether B-cell depletion provides meaningful benefit as an adjunctive treatment.
Early Clinical Exploration Could Broaden BRIUMVI’s Therapeutic Potential
Commenting on the study, Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, said emerging evidence linking immune dysfunction with schizophrenia, together with encouraging preliminary experience using rituximab, provides a scientific rationale for evaluating B-cell depletion in treatment-resistant disease. He noted that BRIUMVI’s rapid and efficient B-cell depletion and established safety profile make it a suitable candidate for clinical investigation in this setting.
If the trial demonstrates meaningful symptom improvement, it could support further development of BRIUMVI in schizophrenia and expand the therapeutic role of CD20-targeted immunotherapy beyond autoimmune diseases. Results from the Phase 2 study are expected to guide future clinical development and determine whether larger controlled studies are warranted.
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About the Writer
Amit Kumar Bharti (LinkedIn) is a pharmacy graduate from DPSRU, Delhi and healthcare writer with a strong interest in pharmaceutical research, medical writing, and evidence-based healthcare communication. He is passionate about translating complex scientific and medical information into clear, accurate, and engaging content for healthcare professionals and the pharmaceutical industry. His focus includes emerging therapies, clinical research, and recent advances in medicine.