After shutting down a Phase 3 program last March, Biogen now says the futility analysis it did was incorrect, and that a new analysis of a larger dataset in fact supports filing for FDA marketing approval next year.
Researchers consider the data encouraging, though questions linger about the cognition results. Did regulators mess up the randomization of this trial?
After veru- and atabecestat, now a third β-secretase inhibitor, by Eli Lilly and AstraZeneca, is being pulled from ongoing Phase 3 trials of symptomatic Alzheimer’s disease.
Injected into the cerebrospinal fluid, a viral vector delivers the lysosomal protein into the human brain. In mice, a protein transport vehicle delivered into the blood does the same.
A meta-analysis of 2.8 million people estimates 119 in 100,000 develop dementia before age 64—twice the previous estimates. Prevalence increases with age and strikes men and women equally.
In some patients, the blood Aβ42/40 test fell too close to the cutoff for specialists to confidently diagnose AD. Comorbidities, drugs also complicate results. Two CSF tests are FDA-approved.
To modulate synapses, Aη weakens ion flux through glutamate receptors and strengthens their non-ionotropic signaling. This dual action is a first, say scientists.
In a small dose-finding study, Roche’s new brain-shuttle-based anti-amyloid antibody mopped up nearly all plaques in three months, without triggering edema.