The most advanced drug candidate is BAN2401, a humanized monoclonal antibody selectively targeting the toxic amyloid-beta oligomers/protofibrils, which are central for disease progression and neuronal toxicity in Alzheimer’s disease.
BAN2401 is in clinical development as the company’s first immunotherapy developed with BioArctic’s patented technology.
All development of BAN2401 in Alzheimer’s disease is conducted in partnership with the Japanese pharmaceutical company Eisai.
BAN2401 Phase 2b clinical trial (NLT01767311) in early Alzheimer’s disease patients in the US, Canada, EU, Japan and South Korea is completed.
The 18 months results of the BAN2401 Phase 2b study in 856 early Alzheimer’ disease patients have been announced in 2018. BAN2401 significantly slowed the rate of disease progression at the highest dose arm (10 mg/kg twice a month) compared to placebo. The effects of BAN2401 on clinical endpoints were supported by strong effects on amyloid PET as well as effects on several CSF biomarkers. Good tolerability was reported in the study with BAN2401. Please see the press releases from July 6, July 25 and October 25 for more information. Learn more about the Phase 2b study with BAN2401, summary.
BioArctic’s partner Eisai is currently discussing the next steps for BAN2401 with regulatory authorities and preparing for further clinical studies. An open-label extension study for the participating patients in the clinical Phase 2b study with BAN2401 was initiated late 2018.
In March 2019, Eisai announced that they have initiated the confirmatory Phase 3 study with BAN2401 in early Alzheimer patients.