Failures halt Phase III trials of infused Alzheimer's drug

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Failures halt Phase III trials of infused Alzheimer's drug
Failures halt Phase III trials of infused Alzheimer's drug
Pfizer, Johnson & Johnson, and Elan said all Phase III tests of Alzheimer's drug bapineuzumab are being halted after the drug failed to hit its goals for cognition and global function.

The Phase III tests involved the infusion form of the drug and were being conducted among patients with mild to severe forms of the neurological disease. The August announcement came 15 days after the companies said the drug also had failed to hit goals in another Phase III trial.

With bapineuzumab, along with Eli Lilly's own Alzheimer's candidate solanezumab, considered long shots by many, the immediate fallout of the news has been little more than a shrug. Sanford Bernstein analyst Tim Anderson wrote in a research note that he never even bothered to front-load Pfizer forecasts with the possibility that bapineuzumab could become viable.

The drug is not completely dead, however. Pfizer said its Phase II studies with ACC-001 (active immunization) and a Phase II neuroimaging study, called SUMMIT (bapineuzumab delivered subcutaneously), remain up and running.

Anderson speculated that Pfizer's Phase II commitment may signal interest in using the drug as a preventive treatment among patients who are symptom-free. Such a tack would put bapineuzumab into direct competition with an approach Genentech and AC Immune are pursuing to fight the disease, albeit via a different mechanism.

Genentech's approach targets tau proteins, unlike bapineuzumab, which targets beta amyloid protein, which are associated with brain plaques that are linked to the disease.

Moving forward, Lilly has yet to announce Phase III results on solanezumab. Leerink Swann's Seamus Fernandez wrote that he put the odds of a successful Phase III trial for solanezumab at less than 5%. He also wrote that bapineuzumab's failure only enhanced his low expectations for the drug becoming any sort of contender.
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