TG Therapeutics will present B-cells data on BRIUMVI at AAN 2025 annual meeting in San Diego.
From GlobeNewswire: 2025-03-07 07:30:00
TG Therapeutics, Inc. (NASDAQ: TGTX) will showcase BRIUMVI data for multiple sclerosis patients at the AAN 2025 annual meeting in San Diego. Presentations include a study on Ublituximab treatment and serious infections. The schedule also features a retrospective survey on infusion tolerability and a phase 4 observational study for MS patients. Additional results from the ULTIMATE I and II studies will be shared, along with data on a modified Ublituximab regimen. BRIUMVI, a monoclonal antibody targeting CD20-expressing B-cells, is designed for autoimmune disorder management. The ULTIMATE I & II trials enrolled 1,094 RMS patients across 10 countries. BRIUMVI, a new treatment for relapsing forms of multiple sclerosis, uses glycoengineering to efficiently deplete B-cells at low doses. However, the drug comes with important safety information, including contraindications for patients with active Hepatitis B Virus infection or a history of life-threatening infusion reactions to BRIUMVI. Infusion reactions are common, occurring in 48% of patients who received premedication, and infections are another risk, with serious bacterial and viral infections reported in BRIUMVI-treated patients. Patients should be monitored for Progressive Multifocal Leukoencephalopathy and Hepatitis B Virus reactivation while on BRIUMVI. Vaccination guidelines should also be followed, especially for infants born to mothers treated with BRIUMVI during pregnancy. Depletion of B-cells in infants may increase risks from certain vaccines, but inactivated or non-live vaccines can be given before B-cell recovery. BRIUMVI may cause fetal harm and decreased immunoglobulin levels. The most common adverse reactions to RMS trials were infusion reactions and upper respiratory tract infections. TG Therapeutics offers BRIUMVI Patient Support for U.S. patients undergoing treatment. Approximately 1 million people in the U.S. have MS, with RRMS being the most common form. TG Therapeutics focuses on developing treatments for B-cell diseases, including BRIUMVI for RMS. Multiple studies have shown the effectiveness of BRIUMVI for treating RMS. TG Therapeutics has identified potential risks that could impact the results of their clinical trials for BRIUMVI, including changes in data and potential safety concerns. These risks could affect the commercial success of the drug in the treatment of RMS. The company also highlighted the importance of regulatory approvals and the potential impact of the ongoing COVID-19 pandemic on their research and development efforts. For more information, interested parties can refer to the company’s filings with the U.S. Securities and Exchange Commission.
According to the National Multiple Sclerosis Society, the prevalence of MS is a significant concern, affecting a large number of individuals globally. Data from the Multiple Sclerosis International Federation in 2013 further emphasizes the impact of this disease on a global scale.
Read more at GlobeNewswire: TG Therapeutics Announces Schedule of Data Presentations