The biopharmaceutical group Biogen has won a victory in the challenging area of Alzheimer’s disease, with its announcement this week that a mid-stage study for its key experimental drug targeting the illness shows promise.
In a Phase II study, patients with early cases of Alzheimer’s who received the highest dose (10mg) of the treatment BAN2401 saw less of an erosion in their cognitive faculties after eighteen months of treatment compared to those who took a placebo.
The treatment reduced the build-up of toxic plaque in the brain and improved cognition, according to Biogen and its partner Eisai, the Japanese drug maker.
“This is the first late-stage antiamyloid antibody study to successfully achieve statistically significant results at 18 months, further validating the amyloid hypothesis,” said Dr. Lynn Kramer, chief medical officer in Eisai’s Neurology group. “We will discuss these very encouraging results with regulatory authorities to determine the best path forward.”
Detailed results of the study will be presented at future medical conferences, but the two companies haven’t yet offered specifics on the likely roll-out of Phase III trials.
“I look forward to seeing the full data set shared with the broader Alzheimer’s community as we advance against this devastating disease,” said Dr. Jeff Cummings, founding director of the Cleveland Clinic's Lou Ruvo Center for Brain Health.
Biogen and Eisai did say they intend to engage in discussions with regulators about the next stages of clinical trial work required to bring the drug to market.
Last December, BAN2401, which was tested in a study analyzing 856 patients, failed to meet its first benchmark of performing better than a placebo at twelve months of treatment. But Biogen and Eisai continued with the trial and found that BAN2401 showed considerable promise after 18 months of treatment.
BAN2401 holds so much potential as it manages to break down and reduce the amount of toxic beta amyloid plaque in the brain, which destroys the memories of patients with Alzheimer’s.
In response to the news, Biogen shares gained 13.5% in pre-market trade to US$339.03 while in Tokyo, Eisai’s shares (TYO:4523) climbed 19.5% to 9,206Y.