TG Therapeutics Starts Phase 2 Trial of BRIUMVI in 60 Treatment-Resistant Schizophrenia Patients
TGTX•TG Therapeutics has launched an open-label Phase 2 trial evaluating BRIUMVI in approximately 60 adults with schizophrenia unresponsive to standard antipsychotics. The study’s primary endpoint is the proportion of participants achieving at least a 20% reduction in PANSS total score at Week 12.
1. Trial Initiation and Design
TG Therapeutics has initiated an open-label, single-arm, multicenter Phase 2 study of BRIUMVI (ublituximab-xiiy) in approximately 60 adults aged 18 to 60 with treatment-resistant schizophrenia who remain symptomatic despite standard antipsychotic therapy. Participants will continue background antipsychotics and receive intravenous BRIUMVI under close monitoring.
2. Mechanism and Rationale
BRIUMVI is a glycoengineered anti-CD20 monoclonal antibody designed for efficient B-cell depletion at low doses. Emerging evidence links immune dysregulation and neuroinflammation to schizophrenia in a subset of patients, and preliminary findings with rituximab have supported further investigation of this approach.
3. Endpoints and Safety
The trial’s primary endpoint is the proportion of participants achieving at least a 20% reduction in PANSS total score at Week 12. Secondary assessments include additional efficacy measures, safety evaluations and tolerability, with special attention to infusion-related reactions and infection risks.
