Biogen (BIIB 343.20, +44.39) has spiked 14.9% in premarket after
the company's Phase II study of an anti-amyloid beta protofibril antibody
showed positive results in patients with early Alzheimer's disease. Today's
pre-market gain has lifted Biogen to levels not seen since early February.
Biogen's Study 201 is being conducted in collaboration with
Japan's Eisai. Shares of Eisai spiked 19.5% in Tokyo overnight.
Last evening, the two companies announced that Study 201, a study of 856 patients with mild cognitive
impairment due to Alzheimer's disease or mild Alzheimer's dementia, achieved statistical
significance on key endpoints at 18 months. The study showed slowing
progression in Alzheimer's Disease Composite Score and a reduction of amyloid
accumulated in the brain, measured with a PET scan.
The drug candidate showed acceptable tolerability profile through
18 months of administration with infusion-related reactions representing the
most common side effect. These reactions were mostly mild to moderate in
severity. The two companies will present detailed results of the study at
future academic conferences.
Eisai's Chief Clinical Officer and Chief Medical Officer of the
company's Neurology Business Group, Lynn Kramer, M.D., commented on the
results, saying "This is the first late-stage anti-amyloid antibody study
to successfully achieve statistically significant results at 18 months, further
validating the amyloid hypothesis."