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Masitinib (AB1010)

Other names: AB1010

Masitinib is an experimental drug treatment for secondary and primary progressive MS. It is taken as a tablet, twice daily.

Summary

Masitinib for secondary progressive MS: Phase III

 


Masitinib for primary progressive MS: Phase III




Masitinib is an experimental drug treatment for secondary and primary progressive MS. It is taken as a tablet, twice daily.

  • Masitinib blocks a number of biochemical processes involved in inflammation and immune responses. It targets mast cells, a type of cell involved in allergic reactions.
  • In a small study, several measures of MS disease activity improved from month 3 of the study for those treated with masitinib, and worsened in those taking placebo. This difference was maintained for the course of the study.

How does masitinib work?

Masitinib belongs to a class of drugs called tyrosine kinase inhibitors which block biochemical processes involved in inflammation and the immune responses. This results in a reduced immune response and less inflammation. Masitinib targets mast cells, a type of cell involved in allergy and inflammation.

Masitinib has been licensed in Europe for veterinary use. It is now being investigated in human diseases, including treatment of tumours, rheumatoid arthritis as well as secondary and primary progressive MS.

How is masitinib taken?

Masitinib is taken as a tablet, twice daily.

Masitinib research

What are the results so far?

In a small phase II study, 35 people with primary and secondary progressive MS took either masitinib or placebo for 18 months. After 3 months of treatment those taking masitinib had an improvement in their MS Functional Composite (MSFC) score, a measure which assesses walking ability, hand and arm coordination and mental function. Those taking placebo had a worsening in their MSFC score. This difference between masitinib and placebo groups was maintained until the end of the study at 18 months. Other measures also showed some improvement for those taking masitinib, compared to placebo. While the results were not statistically significant, they gave grounds for a larger scale phase III study.

What further research is planned?

  • Masitinib in patients with primary progressive or relapse-free secondary multiple sclerosis

Recruiting 450 participants at study centres in USA and France. Participants will take either masitinib or placebo for 20 months. Main measure of the study is the Multiple Sclerosis Functional Composite (MSFC), which assesses mobility, hand/arm coordination and cognitive function.
Estimated completion date December 2019. Further details of this study.

Side effects

Masitinib is relatively well tolerated with the most common side effects being asthenia (loss of strength and/or energy), rash, nausea, oedema (fluid retention) and diarrhoea.