Lilly targets tau in Alzheimer's effort
Lilly is upping its bet on Alzheimer's. The Indianapolis-based drug maker announced it has licensed experimental tracers that can hone in on and mark tau tangles that are believed to be a cause of the brain-degenerating disease.
The positron emission tomography tracers are from Siemens, and Lilly said in a statement that it will use the technology in its anti-tau and anti-amyloid research.
While Pfizer and Johnson & Johnson ditched their low-expectations Alzheimer's treatment bapineuzumab last August, and Sanofi told the crowds at the San Diego PhRMA conference it was avoiding the field altogether, Lilly has been standing fast.
Like bapineuzumab, Lilly's contender, solanezumab, failed to wow physicians or analysts as clinical trial results rolled in last year. The company spun the results as marking a decent, if modest, advance. The results did not harm the company's reputation on Wall Street, but only because analysts had not included the drugs in their financial models for Lilly.
The “OK” framing was possible when the company uncoupled results for global and cognitive function and presented the results independently. The drawback at the time was that it meant resetting the endpoints, in addition to sidestepping FDA requirements that Alzheimer's medications show progress on both fronts. Solanezumab acts on beta-amyloid proteins.
The FDA's position on the two-for-one results has since shifted, and the regulator issued draft guidance in February outlining the sort of changes it was considering. FDA's head of neurology, Russell Katz, even went so far as to explain the proposed revisions in a Perspectives piece that ran in the New England Journal of Medicine in March. In addition to noting the slew of failures, Katz wrote that studies are increasingly focused on early-stage patients, when cognitive and/or global function impairment may not be in sync and “it might be feasible to approve a drug through the FDA's accelerated approval pathway on the basis of assessment of cognitive outcome alone.”