BAN2401 in the News -- and Donanemab

In Beating the Dementia Monster we mentioned that the prospective Alzheimer's treatment, BAN2401, had shown promise in clinical trials.  We also discussed its prospects on this blog as early as July 2018 and a few times subsequently.  BAN2401 is another monoclonal antibody treatment, which you can tell by the "MAB" ending of its generic name: lecanemab.   Like aducanumab, lecanemab is being developed by Biogen and its Japanese partner, Esai.   

So there is good news for BAN2401 in that the FDA has granted it "breakthrough status."  What is "breakthrough status?"  According to the FDA, its "a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)."  In other words, the FDA thinks the drug is important enough and promising enough that they want to grease the skids in the approval process.  This could begin as early as the phase 1 trial, although BAN2401 has just completed a phase 2b study.  

This is entirely different from the method used by the FDA to actually grant provisional approval to Aduhelm.  

The FDA's decision was based on the recently published results of a Phase 2b clinical trial of 856 patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease with confirmed presence of amyloid pathology.   In this study, an analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses.

But is Biogen the only show in town with monoclonal antibodies for Alzheimer's disease?  Back in April, we discussed Eli Lilly's entry, donanemab.  It too has shown enough promise to win it breakthrough therapy status.  This was announced was just days before the FDA acted on BAN2401.  It's evident that there is momentum in the world of monoclonal antibody treatments for Alzheimer's disease. 

Bear in mind that none of these treatments is a cure.  They appear to slow the progress of the disease, including the slowing of cognitive decline and memory loss.  They also support the idea that further research based on the amyloid hypothesis will bear fruit.