Policy & Regulation
Phase 2b Study of BioArctic's Treatment for Early Alzheimer's Disease Yields Positive Results
12 July 2018 - - Stockholm, Sweden-based research biopharmaceutical company BioArctic AB (STO: BIOA B) has released positive topline results from the phase 2b study with BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia with confirmed amyloid pathology in the brain at the start of the study, the company said.
Although 12 month results did not meet the primary endpoint, the study continued following the predefined study protocol with a comprehensive final analysis on treatment conducted at 18 months.
The final analysis of the study demonstrated a statistically significant slowing of disease progression on the Alzheimer's disease composite score (ADCOMS) after 18 months of treatment in patients receiving the highest treatment dose of 10 mg/kg twice a month and reduction of amyloid accumulated in the brain as measured by using amyloid positron emission tomography (PET).
Dose-dependent changes from baseline were observed across the PET results and the clinical endpoints. Further, the highest treatment dose of BAN2401 began to show statistically significant clinical benefit as measured by ADCOMS as early as 6 months including at 12 months.
BAN2401, a humanized monoclonal antibody, selectively binds to toxic amyloid-beta aggregates that are thought to contribute to the neurodegenerative process in Alzheimer's disease. As such, BAN2401 has the potential to have an effect on the disease pathology and to slow down the progression of the disease.
BioArctic is focusing on disease modifying treatments and reliable biomarkers and diagnostics for neurodegenerative diseases, such as Alzheimer's disease and Parkinson's disease. The company is also developing a potential treatment for complete spinal cord injury.
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