On 25 October, Biogen, a leading global biotechnology company that has pioneered multiple breakthrough innovations, presented new findings from its Phase Ib study of BIIB080 in mild Alzheimer’s disease (AD) at the 2023 Clinical Trials on Alzheimer’s Disease (CTAD) meeting held in Boston. The Phase Ib trial and its long-term extension study (LTE) were designed to assess the safety and tolerability of multiple doses of BIIB080 in people with mild dementia due to AD. BIIB080 is designed to target microtubule-associated protein tau (MAPT) mRNA and reduce production of tau protein.
The company reported that it is the first study of a tau targeting drug that shows reduction of aggregated tau pathology with favourable trends on clinical outcomes. Findings previously reported showed a reduction of tau protein in the cerebral spinal fluid (CSF) and aggregated tau pathology as measured by positron emission tomography (PET) across all brain regions assessed. In the results presented at CTAD, favourable trends were observed on cognition and activities of daily living including the global Clinical Dementia Rating Sum of Boxes (CDR-SB), Mini-Mental State Exam (MMSE) cognitive scales and Functional Activities Questionnaire (FAQ) at week 100 in groups treated with a high-dose of BIIB080. Treatment was generally well tolerated throughout the study.
The majority of adverse events were mild or moderate in severity, of which the most common were headache, back pain, pain in extremity, post-lumbar puncture syndrome and procedural pain. Recruitment for the Phase II CELIA study evaluating the potential of this compound in mild cognitive impairment or mild dementia due to AD, is underway in North America, Europe and Asia Pacific.