On 29 March, the global biotechnology company Biogen presented data from its BIIB080 Phase Ib trial at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD) in Gothenburg, Sweden. The Phase Ib trial and its open-label long-term extension (LTE) study was designed to evaluate the safety and tolerability of multiple dose levels of BIIB080 in people with mild Alzheimer’s disease (AD). BIIB080 is targeting microtubule-associated protein tau (MAPT) mRNA and prevent production of tau protein. Results showed that BIIB080 reduced biomarkers of soluble tau in cerebrospinal fluid (CSF) in a dose-dependent and sustained manner, with all dose groups showing approximately a 60% reduction from baseline CSF tau levels by the end of the LTE.
BIIB080 also reduced aggregated tau pathology, as measured by positron emission tomography (PET) in all brain composites assessed. In this study, the majority of adverse events were mild or moderate in severity, of which the most common were headache, back pain, and post-lumbar puncture syndrome. The company is conducting a Phase II trial of BIIB080, called CELIA, in the US to further evaluate BIIB080 in people with mild cognitive impairment and mild dementia due to AD. The main goal is to test whether BIIB080 can slow dementia progression, as assessed by the Clinical Dementia Rating (CDR) scale.