Biogen and Eisai, whose collaboration for experimental Alzheimer’s drug aducanumab drew much attention, announced a phase-3 trial start on another candidate, BAN2401.
Biogen said Monday that it would begin the phase-3 AHEAD 3-45 trial on BAN2401, an anti-amyloid beta protofibril antibody that the company is working on, jointly with Eisai.
The two companies have already been conducting the phase-3 Clarity AD study on BAN2401 in patients with early Alzheimer’s disease. The study is expected to reach the primary endpoint in February 2022. If the schedule goes as planned, the drug would be the first to reach the end stage among rivals being developed by other pharmaceutical firms.
The AHEAD 3-45 trail will compare BAN2401 with placebo in preclinical patients who are clinically normal but have intermediate or elevated levels of amyloid-beta in the brain.
The study will be a public-private partnership between the Alzheimer’s Clinical Trials Consortium (ACTC), funded by the National Institute on Aging (NIA) under the U.S. National Institutes of Health, and Eisai.
Dr. Reisa Sperling, the co-principal investigator of the ACTC and director of the Center for Alzheimer Research and Treatment at Brigham and Women’s Hospital, hoped that initiating treatment much earlier in the disease process may be advantageous in preventing future cognitive decline.
“The AHEAD 3-45 should provide critically important answers about the optimal time to intervene with anti-amyloid therapy,” she said.
After a common screening period, the researchers will enroll patients into one of two randomized, double-blind, placebo-controlled trials, A45 and A3, based on the amyloid level in the brain. A total of 1400 participants will be treated with BAN2401 for 216 weeks.
According to ClinicalTrals.gov, the AHEAD 3-45 trial is to reach the primary endpoint in October 2027.
Biogen recently said it has completed submitting a Biologics License Application (BLA) for aducanumab to the FDA, hoping to sell the world’s first Alzheimer’s drug.
Within the next 60 days, the FDA has to decide whether to accept Biogen’s BLA for aducanumab. If it agrees to it, it has to decide whether to conduct a priority review on the drug.
Biogen’s corporate value is rising as another candidate, BAN2401, is to be tested in the phase-3 trial under the public-private partnership.
Roche’s gantenerumab and Lilly’s solanezumab, anti-amyloid beta antibodies, are also in phase-3 trials.
The Graduate 1 and 2 studies on gantenerumab in early Alzheimer’s patients are expected to achieve the primary endpoint in May 2022, and the A4 trial on solanezumab in preclinical Alzheimer’s, in July 2022.