Surge of Alzheimer’s drugs in pipeline gives hope of progress

The FDA hasn’t approved a new Alzheimer’s drug approved since 2003 –  but all this could change in the next five years according to a new analysis.

A report by ResearchersAgainstAlzheimer’s (RA2) presented at the Alzheimer’s Association International Conference in London shows there are 27 phase 3 and eight phase 2 Alzheimer’s drugs that could launch in the next five years.

There are currently 23 drugs in phase 2 and 3 trials targeting amyloid protein build up in the brain, while 28 drugs are targeting neurotransmitter activity.

Lilly’s solanezumab famously failed to produce significant results in early stage Alzheimer’s late last year, the latest in a long list of drugs that have come up short in trials.

George Vradenburg, UsAgainstAlzheimer’s co-founder and chairman, said: “The Alzheimer’s disease pipeline, marred by decades of failures and underinvestment, is due for big victories.”

“Thanks to growing investment from industry leaders, we remain cautiously optimistic that the current crop of late-stage Alzheimer’s innovations will bring much-needed solutions to families in the near future.”

But despite this upbeat message, what the analysis does not show is that some of the closest-to-market drugs are already having issues.

AB Science’s masitinib is top of the list and could be launched first, as a phase 3 trial is due to complete later this year, with a filing shortly afterwards.

However masitinib ran into trouble with European regulators from the CHMP scientific committee, who were reviewing the drug for indolent systemic mastocytosis after an inspection found serious failings in the way a study has been conducted.

It’s not clear whether this will affect R&D in Alzheimer’s, but the French biotech will have to address this issue before it can refile the drug in indolent systemic mastocytosis.

Otsuka and Lundbeck could file brexpiprazole next year – but results of two studies in agitation related to Alzheimer’s were mixed.

Although one study met an endpoint assessing agitation relative to placebo, another did not, with the companies blaming problems with data collection in a study conducted in Russia.

Another example is Roche/MorphoSys’ gantenerumab, which failed to produce results in early stage Alzheimer’s a few years ago.

Nevertheless the companies are soldiering on with two phase 3 trials at a higher dose.

Other big antibody drugs on the list include Roche’s crenezumab and Biogen’s aducanumab – but results of phase 3 trials are several years away.

While it’s reassuring that there is so much research into Alzheimer’s, experience over the last two decades suggests that many of these trials could also prove to be dead ends.

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