Phase 2 trial to evaluate the effects of B-cell depletion with BRIUMVI in approximately 60 patients with treatment-resistant schizophrenia based on emerging evidence linking immune dysfunction to disease in a subset of patients
NEW YORK, July 06, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the initiation of a Phase 2 clinical trial evaluating BRIUMVI® (ublituximab-xiiy), in adults with treatment-resistant schizophrenia.
The Phase 2 study is an open-label trial designed to evaluate the efficacy and safety of BRIUMVI in approximately 60 adults with schizophrenia who continue to experience significant symptoms despite receiving standard-of-care antipsychotic treatment.
Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated, "The initiation of this Phase 2 study represents an exciting step in exploring the potential role of B-cell depletion in schizophrenia. There is emerging scientific evidence suggesting that immune system dysfunction and neuroinflammation may play a role in the pathophysiology of schizophrenia in a subset of patients. This scientific rationale is further supported by encouraging preliminary clinical findings with rituximab in a small cohort of patients with treatment-resistant schizophrenia, supporting further investigation of B-cell depletion in this condition. Given BRIUMVI's demonstrated ability to rapidly and efficiently deplete B cells and its established safety profile, we believe it is a compelling candidate to explore in this setting. This study is designed to determine whether B-cell depletion with BRIUMVI can improve symptoms in patients with treatment-resistant schizophrenia and, if successful, could expand the potential utility of BRIUMVI into a significant area of unmet medical need. We look forward to sharing results as they become available."
OVERVIEW OF THE PHASE 2 SCHIZOPHRENIA STUDY
The Phase 2 study is an open-label, single-arm, multicenter trial evaluating the efficacy and safety of BRIUMVI (ublituximab-xiiy) in adults with treatment-resistant schizophrenia. Approximately 60 participants between the ages of 18 and 60 years are expected to be enrolled.
Participants will receive intravenous BRIUMVI and remain on background standard-of-care antipsychotic therapy throughout the study. The primary endpoint is the proportion of participants achieving at least a 20% reduction from baseline in PANSS total score at Week 12, a commonly used threshold for clinical response in schizophrenia studies. Secondary endpoints include additional standard efficacy assessments as well as safety and tolerability.