Biogen Inc. (NASDAQ: BIIB) shares jumped early on Friday after the firm, in conjunction with Eisai out of Japan, announced positive results from a midstage Alzheimer’s study. The topline results came from the Phase 2 study with BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer’s disease.
Overall, the study achieved statistical significance on key predefined endpoints evaluating efficacy at 18 months on slowing progression in Alzheimer’s Disease Composite Score (ADCOMS) and on reduction of amyloid accumulated in the brain as measured using amyloid-PET (positron emission tomography).
Further, the highest treatment dose of BAN2401 began to show statistically significant clinical benefit as measured by ADCOMS as early as six months, including at 12 months.
The most common treatment-emergent adverse events were infusion-related reactions and amyloid-related imaging abnormalities. Infusion-related reactions were mostly mild to moderate in severity.
Lynn Kramer, M.D., chief clinical officer and chief medical officer of Eisai’s Neurology Business Group commented:
This is the first late-stage anti-amyloid antibody study to successfully achieve statistically significant results at 18 months, further validating the amyloid hypothesis. We will discuss these very encouraging results with regulatory authorities to determine the best path forward. We continue to work towards the goal of delivering BAN2401 to patients and healthcare professionals as early as possible.
Shares of Biogen closed Thursday at $298.81, with a consensus analyst price target of $349.81 and a 52-week trading range of $249.17 to $370.57. Following the announcement, the stock was up about 13% in early trading indications Friday.