#CMSC2018 – New Phase 2 Data Supports Ublituximab in Effectively Lowering Relapses, Depleting B-cells in MS Patients

New results from a Phase 2 trial evaluating TG Therapeutics’ ublituximab continue to support the therapy’s efficacy in treating relapsing forms of multiple sclerosis (MS). This investigative infusion therapy is now moving into a Phase 3 study.

Treatment with 450 mg of ublituximab delivered intravenously in a rapid fashion (as little as one hour) was well-tolerated and induced a massive depletion of immune B-cells, data show. Importantly, the treatment led to a remarkable reduction in lesions in the brain and spine cord of patients, and significantly halted disability progression.

These results were in a presentation titled “Phase 2 Multicenter Study Results of Ublituximab, a Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb), in Patients with Relapsing Forms of Multiple Sclerosis,” given by Edward Fox, MD, PhD, at the 2018 CMSC Annual Meeting, that ran from May 30 to June 2, in Nashville, Tennessee.

Ublituximab (TG-1101) works by targeting a region of the CD20 protein that is present in immune B-cells, which are known to be involved in MS development.

The Phase 2 trial (NCT02738775) randomized patients with relapsing forms of MS to receive intravenous infusions of either ublituximab or a placebo on days  1 and 15, and again at week 24. Infusions of 150 mg of were given on day 1, followed by 450 mg or 600 mg doses on day 15 and at week 24.

The trial recruited 48 patients, and the majority (46) completed 24 weeks of treatment.

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Side effects from treatment with ublituximab were reported in 83% of patients, but most were minor and its use was considered safe. The majority of adverse events were infusion-related reactions (42%), headaches (21%), and fatigue (19%). No serious adverse events were reported.

Ublituximab was well-tolerated and no patients stopped the study for reasons related to treatment.

Signs of efficacy were strong, data show. Ublituximab treatment resulted in a nearly complete depletion of B-cells (99%) detected at week 4, which was maintained at week 24 in 44 of the 46 patients.

These 44 patients were also free of gadolinium-enhancing lesions — or damaged nerve cell areas — six months after treatment.

Another important finding was that 98% of the ublituximab-treated patients were relapse-free by week 24, and 83% showed no disability progression during this period.

In fact, patients’ disability improved during the six months — their mean score on the Expanded Disability Status Scale at the study’s start of the study was 2.41, and it fell to 2.12 at week 24 (the lower the score, the milder is the disability level).

“Final results from this Phase 2 are expected to be presented at an upcoming major medical meeting and support the currently ongoing ULTIMATE Phase 3 trials in relapsing forms of multiple sclerosis,” Fox said during his presentation.

The ULTIMATE 1 double-blind study (NCT03277261), currently enrolling 440 relapsing MS patients at sites across the U.S., will evaluate ublituximab’s effectiveness in lowering the number of annual patient relapses compared to Genzyme’s Aubagio (teriflunomide), an oral disease-modifying MS therapy, after 96 weeks of treatment.

For more information about this trial and how to participate, please visit this link.