Eisai indicated Monday alongside its third-quarter financial results that it plans to initiate a Phase III confirmatory study of BAN2401 in early Alzheimer's disease patients by the end of March. The company noted that following feedback from regulators in the US, EU and Japan, a single trial of the anti-amyloid beta protofibril antibody would meet the requirements for approval.
The drugmaker, which is co-developing BAN2401 with Biogen, said that it would also "continue to seek opportunities with health authorities for potential earlier approval." Eisai added that regulators in the US, EU and Japan acknowledged that results from the mid-stage Study 201 showed "robust data on dose-dependent reduction of amyloid plaque in the brain and preliminary evidence of slowing clinical evidence."
Eisai indicated that it has initiated an open-label extension of Study 201, with data from more than 200 patients given the 10mg /kg bi-weekly dose of BAN2401 expected. Last year, Eisai and Biogen announced that a final analysis of the trial showed that the highest dose of BAN2401 significantly slowed clinical decline versus placebo and reduced amyloid beta in the brain in patients with early Alzheimer's disease. In an earlier analysis, the study's independent data monitoring committee determined that BAN2401 "did not meet the criteria for success" based on an analysis for the primary endpoint at 12 months.
Eisai licensed exclusive global rights to BAN2401 from BioArctic in 2007, and has been jointly developing the drug with Biogen under the terms of a 2014 agreement focused on treatments for Alzheimer's disease.
The news comes shortly after Roche halted two Phase III studies of the anti-beta-amyloid molecule crenezumab in patients with early sporadic Alzheimer's disease after a pre-planned interim analysis indicated that the trials were unlikely to meet their primary endpoints. For related analysis, see ViewPoints: Strike three – but the amyloid hypothesis ain't out and The drugs that will shape 2019.
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