Masitinib (also known as Kinavet® and Masivet®)
Experimental Medications: Other Therapeutic Strategies
Company: AB Science
Masitinib is termed a protein-kinase inhibitor. It selectively inhibits molecules (kinases) that play a major role in the activation of mast cells. Although mast cells are best known for their role in allergies, they are also involved in the immune response, in the recruitment of lymphocytes to the brain, and also in inflammatory processes associated with MS. As noted earlier, lymphocytes are immune-system cells produced to fight infection and disease. Additionally, lymphocytes can initiate myelin damage.
Masitinib has a role in veterinary medicine (it is used to fight mast cell tumors in dogs) and is being studied for several human indications, including cancers and degenerative diseases. A small Phase II trial of masitinib in progressive forms of MS showed a trend toward benefit; however, the results were not statistically significant.
A double-blind, randomized, placebo-controlled trial with more than 650 patients currently is assessing the safety and efficacy of masitinib in PPMS or SPMS without relapses. The primary endpoint is the change during the course of 96 weeks in EDSS, which measures disability in MS, including changes in disability over time.
In January 2018, AB Science announced that a planned interim analysis was performed after half of the trial’s participants had completed 96 weeks of treatment. The analysis was conducted to assess, among other things, whether the trial had an adequate number of patients to address the question it is studying and whether the data obtained so far warrant continuing the trial. An Independent Data Safety Monitoring Committee (IDMC) reviewing the available data recommended that the trial continue without any change to the “sample size,” or number of participants. Based on the protocol developed for the trial, this indicates that the data available so far suggest that the predictive probability of success of the study with the current sample size is more than 80 percent. This is a hopeful sign that builds anticipation for the release of final study results, which are expected in the first half of 2019.56