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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 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.
  • Results from an early stage clinical trial indicate that ublituximab significantly reduced the number of new active lesions seen on MRI.
  • 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).  In a phase II study, infusions were administered on days 1, 15 and week 24. 

Ublituximab research

What are the results so far?

Results of a phase II study were presented at scientific meetings in 2018.  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.

What further research is planned?

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

These phase III studies have each recruited 440 participants with relapsing remitting MS who are taking either ublituximab or Aubagio (teriflunomide) for 96 weeks.  The main measure of the study is the number of relapses each participant has per year.  The study will also measure side effects of treatment.
Estimated completion date September 2021.
Further details of ULTIMATE I 
Further details of ULTIMATE II 

Side effects

The most common side effect reported in a small phase II study was infusion-related reactions, affecting half of the participants (23 of 48 participants).  Infusion-related reactions were most common with the first infusion but less frequent for the second and third infusions (day 15 and week 24).

References

  • Fox E, et al. Final results of a placebo controlled, phase 2 multicenter study of ublituximab (UTX), a novel glycoengineered anti-CD20 monoclonal antibody (mAb), in patients with relapsing forms of multiple sclerosis (RMS). Multiple Sclerosis Journal 2018; 24(2_Suppl), 87, Abstr 229 Summary
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