Phase 2 Trial Initiated for Briumvi for Treatment-Resistant Schizophrenia

A phase 2 clinical trial has been initiated for Briumvi (ublituximab-xiiy) to evaluate its safety and efficacy in adults with treatment-resistant schizophrenia.¹ Briumvi, an intravenous (IV) monoclonal antibody, will be evaluated in the open-label trial for patients with schizophrenia experiencing symptoms despite standard-of-care treatment.

The phase 2 trial is an open-label, single-arm trial of approximately 60 adult participants (aged 18 to 60) with treatment-resistant schizophrenia.² Participants will receive IV Briumvi and continue on standard antipsychotic therapy through the trial. Primary endpoint evaluation will be on proportion of participants achieving at least 20% reduction from baseline in Positive and Negative Syndrome Scale score at week 12. Secondary endpoints include standard efficacy assessments like change in Clinical Global Impressions-Improvement and Negative Symptoms Assessment, along with safety and tolerability assessment. Participant exclusion criteria are any DSM-5 primary disorder besides schizophrenia, ongoing clozapine treatment, risk of suicidal behavior, and any severe or uncontrolled condition affecting participation ability.

Michael S. Weiss, chairman and chief executive officer of TG Therapeutics, developers of the drug, shared, “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.”

He noted that “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.”

Briumvi is a 150mg/6mL IV injection and a monoclonal antibody that targets an epitope on CD20-expressing B-cells. The molecule is glycoengineered and therefore does not have certain sugar molecules normally expressed on this antibody; this allows for efficient B-cell depletion at lower medication doses.

Briumvi is currently approved in the US to treat adults with relapsing multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, active secondary progressive disease. Outside of the US, it is available in several countries for treatment of adults with active disease RMS. In previous trials for RMS, common adverse reactions to Briumvi included infusion reactions and upper respiratory tract infections. Administration of Briumvi is contraindicated in patients with active Hepatitis B infection or history of life-threatening infusion reaction to the medication.

References

1. TG Therapeutics announces initiation of phase 2 trial evaluating BRIUMVI in patients with treatment-resistant schizophrenia. Press release. July 6, 2026. Accessed July 6, 2026. https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-announces-initiation-phase-2-trial-evaluating

2. Study to evaluate the safety and efficacy of ublituximab in participants with schizophrenia. ClinicalTrials.gov. July 2, 2026. Accessed July 6, 2026. https://clinicaltrials.gov/study/NCT07680946?aggFilters=funderType:industry,status:not,studyType:int&start=2025-01-01_