Biogen says Phase 1b data on BIIB080 in Alzheimer’s showed ‘favorable trends’

Biogen (BIIB) reported new Phase 1b clinical data from the study of BIIB080, an investigational antisense oligonucleotide, or ASO, therapy targeting tau, in mild Alzheimer’s disease, or AD. “The data showed favorable trends on multiple exploratory endpoints of cognition and activities of daily living in AD, building upon prior results which showed a reduction of tau protein in the cerebral spinal fluid and tau positron emission tomography across brain regions,” the company stated. The late-breaking results were presented at the 2023 Clinical Trials on Alzheimer’s Disease, or CTAD, meeting held in Boston, MA from October 24-27. “This is the first time we’ve seen both strong target engagement and favorable trends on clinical outcomes with a novel mechanism targeting tau. While these are preliminary findings, we are excited about these results and continue to enroll the Phase 2 CELIA study. We believe defeating Alzheimer’s disease will take different approaches and we are committed to exploring the targeting of tau as a new generation of treatment,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. Recruitment for the Phase 2 CELIA study, evaluating the potential for this ASO targeting tau to slow the worsening of mild cognitive impairment or mild dementia due to AD, is ongoing at sites across North America, Europe and Asia Pacific. In December 2019, Biogen exercised a license option with Ionis (IONS) and obtained a worldwide, exclusive, royalty-bearing license to develop and commercialize BIIB080, the company noted.