Anti-LINGO-1 Clinical Trial Failure: A Perspective

As you may have heard, Biogen recently reported the results of their Phase 2 SYNERGY study.  This study tested the efficacy of their monoclonal antibody, opicinumab (anti-LINGO-1), as a remyelination therapy for people with relapsing-remitting multiple sclerosis (RRMS).   Whilst full results have yet to be released, Biogen have confirmed that the drug failed to meet its primary endpoint, which measured the effect on disability, as well as physical and cognitive function.

So whilst this is disappointing, what does this actually mean?  Unexpectedly, the failure of the Phase 2 anti-LINGO-1 trial has created a general negativity around the remyelination field.  However, it is important to view these results in the appropriate context.  Despite not reaching their endpoint goals, Biogen have reported that they did observe a clinical effect of opicinumab.  Similarly, they have previous in-human data that shows that this treatment can aid in remyelination.  If this is the case, why did the trial fail?  Unfortunately, new drug trials often fail not because the compound is ineffective, but due to poor trial design or because the drug hasn’t been optimally developed.  In this case, Biogen themselves have decided that “due to the complex nature of the data set, [they will]…continue to analyse the results to inform the design of [the] next study”.

Considering this, why do we let the results of one trial cast a shadow across the whole concept of remyelination?  It is crucially important that we don’t give up on this research and continue to do extensive studies in this area.  In my opinion, there are three crucial areas that MS research should be investigating at the moment:

• Finding a cure (which means understanding the mechanisms and triggers for MS to develop)

• Remyelination (which means developing therapies to repair the existing damage to the myelin)

• Lifestyle factors (which means identifying risk factors to eliminate and understanding aspects of diet, exercise and wellness that can be undertaken on a daily basis to improve quality of life)

As with everything, it is important to not take one study in isolation.  We must understand the details of each individual study (why did they work, why did they not work) and then put that in context with all of the other available information.  We will continue to monitor the anti-LINGO-1 data and provide more detailed reports as they become available.

Written for MStranslate by Brett Drummond