TG Therapeutics has initiated 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 (SoC) antipsychotic treatment.

Michael S Weiss, Chairman and Chief Executive Officer (CEO), 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.”