- Biogen Inc BIIB and Ionis Pharmaceuticals Inc IONS have announced topline data from a Phase 1b study of BIIB080/IONIS-MAPTRx in mild Alzheimer's disease.
- The trial met its primary objective of safety and tolerability. It demonstrated dose-dependent lowering of tau protein in cerebrospinal fluid (CSF) over the three-month treatment period and sustained reductions during the six-month post-treatment period.
- The candidate exhibited a mean percentage reduction of 30%, 40%, and 49% in the low, medium, and high dose groups treated every four weeks, respectively, and 42% in the group treated every 12 weeks.
- Total-tau in the CSF continued to decline 16 weeks post-last dose in patients treated with BIIB080 in the high dose four-week and 12-week dose groups, showing a 55% and 49% mean reduction from baseline, respectively.
- CSF was not collected 16 weeks post-last dose in the low and medium four-week dose groups.
- There were similar dose-dependent decreases in the levels of phosphorylated tau.
- All participants (n=46) completed the Multiple Ascending Dose (MAD) period, and 43 participants completed the Post-Treatment (PT) period (3 participants voluntarily withdrew).
- Price Action: BIIB shares closed at $331.93, and IONS stock closed at $37.42 on Monday.
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