Exciting Updates on BRIUMVI from TG Therapeutics for MS

TG Therapeutics Highlights BRIUMVI Data at Major Neurology Meeting

New York — TG Therapeutics, Inc. (NASDAQ: TGTX) has recently announced the presentation of pivotal data showcasing BRIUMVI (ublituximab-xiiy) for patients diagnosed with relapsing forms of multiple sclerosis (RMS) at a prominent annual neurology conference. The results from this significant meeting provide insight into the derivatives of BRIUMVI, paving the way for advancements in treatment methodologies for MS patients.

Key Highlights from the ENHANCE Trial

Michael S. Weiss, CEO and Chairman of TG Therapeutics, expressed optimism regarding the findings from the ENHANCE trial shared at the event. The trial emphasized the tolerability of a single 600 mg dose of BRIUMVI administered on the first day. This promising approach could soon lead to an innovative clinical trial aimed at consolidating the existing Day 1 and Day 15 dosages into a single regimen. Through these efforts, TG Therapeutics aims to expand treatment options and improve outcomes for individuals living with MS.

Notable Presentations on BRIUMVI and Its Effects

The conference included several notable presentations regarding BRIUMVI, including:

• Poster Title: Efficacy and Safety of a Modified Ublituximab Regimen (ENHANCE)
  Lead Author: Dr. John Foley from Rocky Mountain Multiple Sclerosis
• Poster Title: Five Years of Ublituximab in Relapsing Multiple Sclerosis: Results from the Open-label Extension of ULTIMATE I and II Studies
  Lead Author: Dr. Bruce Cree from the Weill Institute for Neurosciences

These presentations are crucial for understanding how BRIUMVI could influence treatment protocols and patient outcomes in the long run.

Insights into the ULTIMATE Trials

The ULTIMATE I and II studies represent essential components of TG Therapeutics' research strategy, employing a rigorous design for treating RMS over 96 weeks. Enrolling 1,094 participants across multiple countries, these randomized trials provided valuable data on the efficacy of BRIUMVI compared to the standard active comparator, teriflunomide. Professor Lawrence Steinman of Stanford University spearheaded these vital studies, further underscoring the commitment of TG Therapeutics to push the boundaries of MS treatment.

Understanding BRIUMVI's Mechanism and Indications

BRIUMVI stands out as a groundbreaking monoclonal antibody targeting a specific epitope on CD20-expressing B cells, creating a powerful therapeutic tool against autoimmune disorders like RMS. It's formulated through a glycoengineering process that facilitates effective B-cell depletion, making it a viable option for treating adult patients with RMS, including varied conditions such as clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Patient Support Initiatives

To further assist patients in managing their treatment journey, TG Therapeutics has launched the BRIUMVI Patient Support program. This initiative is designed to provide flexible support tailored to the needs of individuals navigating through their treatment paths, ensuring they receive the care and resources necessary to manage their condition effectively.

Common Side Effects and Safety Precautions

As with any therapeutic regimen, BRIUMVI does come with certain adverse effects. The most commonly reported side effects in clinical trials include infusion reactions and upper respiratory tract infections. The company advises monitoring patients closely for potential infusion-related reactions, particularly in the initial treatment phases. Moreover, patients must be educated on the signs of severe infections and the importance of routine screening for Hepatitis B virus before starting therapy.

For patients currently undergoing treatment, it's crucial to seek immediate medical attention upon experiencing severe side effects and adhere to the recommended guidelines for managing adverse reactions, ensuring safety remains the utmost priority.

Frequently Asked Questions

What is BRIUMVI and its use in MS therapy?

BRIUMVI (ublituximab-xiiy) is a monoclonal antibody approved for treating adults with relapsing forms of multiple sclerosis, targeting specific B-cells to reduce disease activity.

What were the results from the recent conference regarding BRIUMVI?

Presentation of data included findings that a single 600 mg dose of BRIUMVI is well tolerated, prompting further research into optimizing treatment dosing.

How can patients access BRIUMVI?

Patients can obtain BRIUMVI through authorized specialty distributors, and more information is available on TG Therapeutics' website.

Are there major side effects associated with BRIUMVI?

Common side effects include infusion reactions and respiratory infections, necessitating monitoring during treatment.

What resources are available for patient support?

TG Therapeutics offers a dedicated patient support program to assist individuals throughout their treatment journey, providing access to resources and personalized support.

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