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The closely watched drug, aducanumab, led to significant reductions
in amyloid plaques in the brain compared with a placebo among the 31
early-stage Alzheimer's patients given titrated, or gradually
increased dosing, according to data from the Phase I study.
"These data appear solid to us, and if anything provide additional
confidence in the program and viability of the titration regimen,"
Evercore ISI analyst John Scotti said in a research note late on
Thursday.
Any successful Alzheimer's drug is expected to reap
multibillion-dollar annual sales.
In the group of trial patients given titrated dosing, 35 percent
experienced a side effect involving a fluid shift in the brain,
compared with 55 percent given a high fixed dose, Biogen said.
Biogen last year began enrollment in two Phase III trials of
aducanumab using titrated dosing, but those results are still
several years away, said Samantha Budd Haeberlein, the company's
vice president, clinical development.
The amyloid reduction and slowing of mental decline seen in patients
in the titration portion of the Phase I study after 12 months of
treatment were similar to what was reported earlier this year for
patients who received fixed doses of aducanumab.
Full details of the study were being presented at an Alzheimer's
meeting in San Diego on Friday.
Patients in the study had either mild or prodromal, meaning early
pre-symptomatic, Alzheimer's disease, researchers said.
Aducanumab works by removing brain plaques largely made from a
protein called beta amyloid. Other companies have also tried to
develop drugs that block beta amyloid, but all failed to
significantly slow cognitive declines, and some were also associated
with brain swelling.
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The most spectacular recent failure was Eli Lilly and Co's
experimental solanezumab, designed to soak up beta amyloid from the
bloodstream.
Lilly last month said its infused drug failed to slow mental
decline, compared with placebo, among patients with mild
Alzheimer's. That largely dashed hopes for the drug and cast further
doubt on whether beta amyloid is the right target for attacking the
memory-robbing disease that affects millions of people.
Some Alzheimer's experts have suggested the approach might work very
early in the course of the disease. They said once brain plaques can
be observed it may already be too late for the drugs to provide
significant benefit.
Biogen shares rose 1.45 percent to close at $289.54.
(Reporting by Bill Berkrot, Ransdell Pierson and Deena Beasley;
Editing by David Gregorio and Will Dunham)
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