TG developing under-the-skin version of MS therapy Briumvi
Company plans to start clinical program this year
TG Therapeutics is working to develop a subcutaneous, or under-the-skin, version of Briumvi (ublituximab-xiiy), its approved therapy for relapsing forms of multiple sclerosis (MS).
The company said it plans to start a pivotal clinical program this year which could support an application seeking approval of the subcutaneous formulation. The new version of Briumvi, which patients can administer themselves, is expected to be given at least every other month.
The company believes the new version of Briumvi “will be attractive to patients and healthcare providers,” Michael Weiss, TG’s chairman and CEO, said in a company press release.
The currently approved version of Briumvi is given intravenously, or by infusion into the bloodstream.
Patients initially receive two infusions, two weeks apart, then every six months. Under the currently approved dosing schedule, the first infusion takes about four hours, and each subsequent infusion takes one hour. TG said it plans to start testing new dosing regimens that would combine the initial two infusions and shorten the time for most infusions to 30 minutes.
‘Further optimizing’ IV version of MS therapy
“In 2025 we also plan to launch pivotal trials aimed at further optimizing intravenous Briumvi for patients with [relapsing] MS, continuing to maintain what we believe is a best-in-class profile,” Weiss said.
Briumvi is an anti-CD20 antibody that works to deplete B-cells, a type of immune cell with a central role in driving MS. The therapy was approved in the U.S. in late 2022 and cleared in Europe the following year.
TG has touted Briumvi’s list price, $59,000 per year, as the lowest of any brand-name MS treatment. In 2024, total revenue from sales of Briumvi in the U.S. surpassed $300 million, and that is expected to increase to more than $500 million in 2025, the company said.
Preliminary fourth-quarter and full-year results show that “U.S. Briumvi net product revenue … far exceeded our initial expectations,” Weiss said. “We believe Briumvi is well positioned to continue to grow and provide value to patients and physicians.”
TG also plans to start testing Briumvi in other autoimmune diseases. And the company plans to start a Phase 1 clinical trial testing azer-cel, a cell therapy it is developing as a treatment for progressive forms of MS, this year.
Azer-cel, originated by Precision Biosciences as PBCAR0191, is an allogeneic CAR T-cell therapy. In this type of therapy, T-cells, a type of immune cell, from a donor are equipped with a lab-made receptor called a chimeric antigen receptor, or CAR, which allows them to target and eliminate certain cells.
In the case of azer-cel, the CAR targets CD19, a protein found at the surface of B-cells. The modified T-cells are infused into the patient, where they are expected to eliminate B-cells and help slow or halt MS progression.
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