Biogen (NASDAQ: BIIB) has released preliminary findings from a Phase Ib trial for BIIB080, a microtubule-associated protein tau (MAPT)-targeting antisense oligonucleotide (ASO) co-developed with Ionis Pharmaceuticals (NASDAQ: IONS). The trial focused on patients with mild Alzheimer’s disease (AD), showing that high doses of the spinal injection led to improvements in cognitive scales and daily activities after 100 weeks.
Trial Results and Clinical Implications
The observed benefits, coupled with previously reported improvements in tau biomarkers, suggest a potential link between a reduction in tau pathology and clinical outcomes. These results indicate that targeting tau protein with ASO technology may offer a new therapeutic approach for AD.
Safety Profile and Comparative Advantage
Most adverse events reported in the trial were mild or moderate, indicating a favorable safety profile. This is particularly significant when compared to Eli Lilly (NYSE: LLY) and Eisai (TYO: 4523) amyloid-beta (Aβ)-targeting drugs donanemab and Leqembi (lecanemab), which have been associated with microhemorrhages and brain swelling.
Future Studies and Recruitment
Biogen is actively recruiting volunteers for a Phase II study aimed at evaluating the potential of BIIB080 to slow the progression of mild cognitive impairment or mild dementia due to AD. This next phase of research will further explore the drug’s efficacy and safety in a larger patient population.-Fineline Info & Tech
