Ublituximab, an investigational anti-CD20 antibody, outperformed Aubagio (teriflunomide) in lowering the frequency of relapses among people with active, relapsing forms of multiple sclerosis (MS), according to top-line data from the Phase 3 ULTIMATE trials.
Full results, including data on safety and secondary goals, are expected to be presented at a medical congress in the first half of 2021. The positive findings are also meant to support a biologics license application submission to the U.S. Food and Drug Designation (FDA) seeking the therapy’s approval by mid-year 2021.
“We are so pleased to share these positive top-line results for our ULTIMATE MS studies,” Michael S. Weiss, executive chairman and CEO of the treatment’s developer, TG Therapeutics, said in a press release. “If approved, ublituximab has the potential to offer patients a one-hour infusion [every six months], which we believe will be an attractive option for many patients with MS.”
Ublituximab is an antibody that works by targeting CD20, a protein found on the surface of B-cells, a type of immune cell known to drive the inflammation that causes nervous system damage in MS.
Being tested also as a potential treatment for B-cell cancers, ublituximab was specifically designed to maximize B-cell death by triggering several cell death-inducing immune responses, particularly antibody-dependent cellular cytotoxicity.
As such, the therapy, administered directly into the bloodstream, is said by the company to have superior potency compared with current anti-CD20 antibodies, allowing for the use of lower doses and shorter infusion times.
“B-cell targeted therapy with anti-CD20 monoclonal antibodies has dramatically shifted the treatment paradigm for patients with MS and has shown to be very effective in reducing relapses in patients,” Lawrence Steinman, MD, Zimmermann professor of neurology and neurological sciences, and pediatrics at Stanford University, who led both ULTIMATE trials.
The ULTIMATE 1 (NCT03277261) and ULTIMATE 2 (NCT03277248) studies evaluated the safety and effectiveness of ublituximab against Sanofi Genzyme’s Aubagio in a total of 1,094 adults with active, relapsing forms of MS.
Aubagio is an approved oral treatment for relapsing MS that is thought to work by decreasing the activity of immune cells, namely B-cells and T-cells.
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