TG Therapeutics to Present BRIUMVI® (ublituximab) Data at 2024 Consortium of Multiple Sclerosis Centers Annual Meeting

TG Therapeutics, Inc. (NASDAQ: TGTX) has announced the details of several presentations scheduled for the 2024 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting. These presentations will focus on the study designs for post-marketing studies of BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS). The CMSC meeting will take place from May 29 to June 1, 2024, in Nashville, Tennessee. The abstracts for these presentations are already accessible online on the CMSC meeting website.

One of the notable presentations is a poster titled "A Post-Marketing Study Evaluating the Presence and Concentration of BRIUMVI in Breast Milk (PROVIDE)." It is scheduled for May 30 from 5:15 PM to 7:15 PM CST. This presentation will be held in the Disease-Modifying Therapy session in Exhibit Hall AB, and the lead author is Dr. Riley Bove from UCSF Weill Institute of Neurosciences.

Another important poster presentation is the "BRIUMVI Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated with BRIUMVI." This is also scheduled for May 30 but from 5:00 PM to 7:00 PM CST in the same session and location. Dr. Riley Bove is also the lead author of this study.

These presentations, along with others, will be available on the Publications page of TG Therapeutics' website under the Pipeline section.

The ULTIMATE I & II Phase 3 clinical trials have been significant in evaluating BRIUMVI's efficacy. These trials were randomized, double-blind, double-dummy, parallel group studies comparing BRIUMVI with teriflunomide in patients with RMS. Patients received BRIUMVI via IV infusion or a placebo, while the comparison group received teriflunomide orally. The trials spanned 96 weeks and included 1,094 patients across 10 countries. Dr. Lawrence Steinman of Stanford University led these trials.

BRIUMVI is a novel monoclonal antibody that targets CD20-expressing B-cells, a method proven effective in managing autoimmune disorders like RMS. The drug is glycoengineered to enhance B-cell depletion at lower doses. BRIUMVI is approved for treating adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

However, BRIUMVI comes with safety considerations. It is contraindicated in patients with active Hepatitis B or those who have had life-threatening infusion reactions to the drug. Infusion reactions are common, occurring in 48% of patients, with severe reactions reported in 0.6% of cases. Infections are another concern, with serious infections occurring in 5% of BRIUMVI-treated patients and fatal infections reported. The drug can also cause Hepatitis B Virus (HBV) reactivation and progressive multifocal leukoencephalopathy (PML), a serious brain infection.

For vaccinations, live or live-attenuated vaccines should be administered at least four weeks before starting BRIUMVI. Non-live vaccines should be given at least two weeks prior. Vaccination safety during BRIUMVI treatment hasn't been studied, and live vaccines are not recommended during treatment.

Pregnant women should be cautious as BRIUMVI can cause fetal harm. Females of reproductive potential are advised to use effective contraception during treatment and for six months after the last dose. Reduced immunoglobulin levels have been observed in patients, which can lead to increased infection risks. Monitoring and potentially discontinuing BRIUMVI may be necessary if serious infections occur.

TG Therapeutics offers a support program called BRIUMVI Patient Support to assist U.S. patients throughout their treatment. RMS affects nearly 1 million people in the U.S., with 85% diagnosed with relapsing-remitting multiple sclerosis (RRMS), which can progress to secondary progressive multiple sclerosis (SPMS).

TG Therapeutics is dedicated to developing and commercializing treatments for B-cell diseases. BRIUMVI has received FDA approval in the U.S., as well as approval from the European Commission and the Medicines and Healthcare Products Regulatory Agency in the UK for treating RMS.

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