MOMENTUM Phase II Trial Results

The background

Fingolimod was approved in 2010 and became the first oral drug for the treatment of relapsing-remitting MS (RRMS).  It has proven to be beneficial for many people with MS and works by modulating the sphingosine 1-phosphate receptor.  This inhibits the ability of immune cells to travel around the body, decreasing the likelihood of autoimmune damage occurring in MS.  However, as with most current MS medications, the risk of side effects is present.  It has been shown that people who receive fingolimod can develop transient cardiac problems, mostly a reduction in heart rate.  This reduction is usually around 8 beats per minute and people are now monitored for around 6 hours after taking the drug.

The study

For this reason, studies are ongoing to develop more effective therapies for RRMS that have less severe side effects.  The Phase II trial results for the MOMENTUM study, testing the safety and effectiveness of amiselimod have just been published in Lancet Neurology.  Amiselimod is a novel compound that targets the same process as fingolimod.

This study was a collaborative trial between the University Hospital Basel, Montreal Neurological Institute, University of London, Heinrich-Heine University and Mitsubishi Tanabe Pharma Europe.

The study involved around 415 people with RRMS that were split into 4 groups:  placebo and three different doses of amiselimod (0.1, 0.2 and 0.4mg).  The groups then underwent a 24 week treatment period, followed by a further 12 week safety follow-up.  The effectiveness of the treatment was measured by looking at total lesion numbers, brain volumes, relapses, EDSS and quality of life (QOL).

The findings

The results of the Phase II trial were as follows:

• People taking the 0.2 and 0.4mg doses of amiselimod had a significantly decreased number of lesions compared to the placebo group between weeks 8-24 of the study.  A reduction was also observed in the 0.1mg group, but it wasn’t statistically significant.

• No groups displayed any significant differences in the change in brain volume across the treatment period.  However, the 0.2 and 0.4mg groups showed a significantly smaller decrease in the decrease in gray matter volume compared to placebo.

• Significant decreases in relapse rate (0.4mg group only) and time to first relapse (0.2 and 0.4mg groups) were observed.  The percentage of people that were relapse free was significantly increased in the higher dose groups as well.

• No significant differences were observed between any of the groups when comparing EDSS and QOL scores.

• Amiselimod was well tolerated by most people in the study.  There were no differences in terms of the adverse events reported across the different groups – the most commonly reported ones were infections and headaches.  There were two instances of cardiac issues, however, these were not clinically significant.

The outcomes

The MOMENTUM study has given initial evidence that suggests amiselimod might be a useful new therapy for RRMS.  In particular, the improved cardiac safety profile makes it an interesting alternative to fingolimod.

Larger Phase III trials will now need to be conducted to test the effectiveness and safety across larger groups and for longer periods of time.

The abstract for this article can be viewed here.