Whither BAN2401?

In Beating the Dementia Monster, we discussed promising drug trial results for another Alzheimer's disease treatment called BAN2401, or lecanemab.  Like aducanumab, the "mab" at the end signals that it's a monoclonal antibody.  As an antibody, it's supposed to attack amyloid plaques and remove them from the brain.  "Monoclonal" indicates that that millions, or likely billions, of the antibodies have been grown in the laboratory from a single cell.  The process began with amyloid antibodies from mice which were then "humanized" -- the protein sequence was copied from the mouse antibody into an antibody that could be administered to humans.

Lecanemab is thought to be a next generation treatment past aducanumab/Aduhelm and therefore more effective.  In phase 1 trials, memory and cognition appeared to improve if the patient was kept on the treatment long enough.  Both Aduhelm and lecanemab have been shown to remove amyloid plaques from the brain.  But Biogen is still trying to prove that leads to a positive effect on the decline of both memory and cognition with Aduhelm.  The hope is that lecanemab will be more effective than Aduhelm.

So where does lecanemab stand today?  Last year, partners Biogen and Esai received "Breakthrough Therapy" designation for lecanemab which provides for an accelerated approval pathway.  By the end of the year, the FDA granted "fast track" designation.  This is the same controversial path that Aduhelm followed.  The treatment was approved for use by the public under certain limited circumstances, but there were doubts regarding whether that was appropriate.  This occurred when Biogen had trouble showing that, even though the treatment removed plaques, it was not clear that it was slowing the decline of memory and cognition.  But there is great hope that lecanemab will fare better in ongoing trials.

The phase 3 trail is in progress now with results expected this summer.  The news is that the FDA has granted the treatment "priority review" status.  This means that, depending on trial results, they could provide some form of approval by January 2023.  Move over Aduhelm.