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Ublituximab

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  1. Summary
  2. How does ublituximab work?
  3. How is ublituximab taken?
  4. Ublituximab research
  5. Side effects

Other names: TG-1101

Summary

Ublituximab is a new drug treatment under investigation for relapsing remitting multiple sclerosis (MS). It is taken as an infusion.

Ublituximab for relapsing remitting MS: Phase III

  • Ublituximab reduces the number of B cell lymphocytes, a type of white blood cell which is thought to influence the abnormal immune response that causes the attack on the myelin coating of nerves.
  • In large clinical studies, ublituximab reduced relapse rate by over 50% compared to Aubagio.
  • The most common side effect reported in a clinical trial was infusion-related reactions.

How does ublituximab work?

Ublituximab is a monoclonal antibody, a type of drug developed to attack specific targets in the immune system. Ublituximab binds to a marker (CD20) on the surface of B cell lymphocytes, a type of white blood cell which is thought to influence the abnormal immune response that causes the attack on the myelin coating of nerves. Targeted B cells are destroyed.

Ublituximab is also being developed as a treatment for some types of blood cancers.

How is ublituximab taken?

Ublituximab is taken as an intravenous infusion (drip). The first dose is given as two separate infusions, two weeks apart. Further doses are given as one infusion every six months.

Ublituximab research

What are the results so far?

In a phase II study, 48 people with relapsing remitting MS took ublituximab by infusion. Ublituximab reduced B cell counts by 99% at 4 weeks after treatment and maintained at weeks 24 and 48. MRI scans showed that active lesions were eliminated while overall lesion volume reduced by 10% at week 48. 93% of participants were free of relapses during the 48 week study.

  • ULTIMATE 1 and 2 - ublituximab compared to Aubagio (teriflunomide)

Results of these phase III studies have been presented at scientific meetings. 1094 participants with relapsing remitting MS took either ublituximab or Aubagio (teriflunomide) for 96 weeks. Compared to Aubagio, ublituximab reduced relapse rate by over 50% in both trials. Ublituximab also significantly reduced the number of active lesions compared to Aubagio. Significantly more people taking ublituximab achieved NEDA (no evidence of disease activity). There was no significant difference between the two treatments in the number of participants with 12 or 24 week confirmed disability progression; however, significantly more participants taking ublituximab had 12 and 24 week confirmed disability improvement.

Further details of ULTIMATE I
Further details of ULTIMATE II

Side effects

The most common side effect reported in phase III clinical studies were infusion-related reactions, which were mostly mild to moderate, most frequent after the first infusion and and less frequent following subsequent infusions.

References

  • Fox E, et al. A phase 2 multicenter study of ublituximab, a novel glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing forms of multiple sclerosis. Multiple Sclerosis. 2021;27(3):420-429. Full paper
  • Steinman L, et al. Efficacy and safety of ublituximab versus teriflunomide in relapsing multiple sclerosis: Results of the Phase 3 ULTIMATE I and II trials (4494) Neurology Apr 2021, 96 (15 Supplement) 4494 Abstract

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