TG Therapeutics to Present BRIUMVI® Data at 2024 MS Centers Meeting
NEW YORK, May 31, 2024 - TG Therapeutics, Inc. (NASDAQ: TGTX) has revealed new study designs for post-marketing research on BRIUMVI® (ublituximab-xiiy) targeting relapsing forms of multiple sclerosis (RMS). These findings were shared at the 2024 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting.
Post-Marketing Studies
Two key poster presentations have been made available:
1. "A Post-Marketing Study Evaluating the Presence and Concentration of BRIUMVI in Breast Milk (PROVIDE)" by Dr. Riley Bove from UCSF Weill Institute of Neurosciences.
2. "BRIUMVI Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated with BRIUMVI" also led by Dr. Riley Bove.
These presentations are accessible on the Publications page under the Pipeline section on TG Therapeutics’ website.
ULTIMATE I & II Phase 3 Trials
The ULTIMATE I & II Phase 3 trials are pivotal studies that evaluated the efficacy of BRIUMVI in patients with RMS. These trials were double-blind, active comparator-controlled, and involved 1,094 patients over 96 weeks. Participants received either BRIUMVI or teriflunomide as a comparative treatment. BRIUMVI was administered initially at 150 mg IV, followed by 450 mg two weeks later, and then 450 mg every 24 weeks, combined with a daily oral placebo. Teriflunomide was administered as a daily 14 mg oral dose along with an IV placebo.
The trials specifically enrolled RMS patients who had experienced relapses or had T1 gadolinium-enhancing lesions in the previous year. The study aimed to assess the efficacy and safety of BRIUMVI in reducing relapse rates and improving patient outcomes. Led by Dr. Lawrence Steinman of Stanford University, the trial’s detailed results are available on ClinicalTrials.gov (NCT03277261; NCT03277248).
About BRIUMVI®
BRIUMVI is a monoclonal antibody designed to target CD20-expressing B-cells, an approach significant in the treatment of autoimmune diseases like RMS. The drug is glycoengineered to enhance B-cell depletion at lower doses by removing certain sugar molecules from the antibody. BRIUMVI is approved for treating adults with various relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Safety Information
BRIUMVI has several contraindications and precautions:
- It is not recommended for patients with active Hepatitis B or those with a history of severe infusion reactions.
- Common adverse reactions include infusion reactions and respiratory infections. Infusion reactions, which occurred in 48% of patients during clinical trials, can range from mild symptoms to severe, potentially requiring hospitalization.
- Serious infections have been reported, with a higher incidence in BRIUMVI-treated patients compared to those treated with teriflunomide.
- Screening for Hepatitis B virus is essential before initiating treatment.
- There is a potential risk for Progressive Multifocal Leukoencephalopathy (PML) although no cases have been reported in BRIUMVI-treated patients.
- Patients should be vaccinated according to guidelines before starting BRIUMVI, as the therapy can affect vaccine efficacy.
- BRIUMVI may pose risks during pregnancy, making contraception advisable during treatment and for six months afterwards.
About TG Therapeutics
TG Therapeutics is a biopharmaceutical company focused on developing treatments for B-cell diseases. The company has received FDA approval for BRIUMVI to treat RMS and aims to support patients through its BRIUMVI Patient Support program.
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic disease affecting the central nervous system, with relapsing forms being the most common. It impacts millions globally, with a significant number of cases in the U.S.
In conclusion, TG Therapeutics continues to advance the understanding and treatment of RMS through its research and development of BRIUMVI. The company remains committed to providing innovative therapies and comprehensive support for patients battling this challenging condition.
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