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Biogen says BIIB080 ‘substantially reduced’ tau protein level in early-stage AD
The Fly

Biogen says BIIB080 ‘substantially reduced’ tau protein level in early-stage AD

Biogen reported Phase 1b clinical data showing that the investigational antisense oligonucleotide therapy, BIIB080, reduced soluble tau protein in cerebrospinal fluid in a dose-dependent and sustained manner in patients with early-stage Alzheimer’s disease. BIIB080 also reduced aggregated tau pathology, as measured by positron emission tomography in all brain composites assessed. The primary endpoint of the Phase 1b trial and open-label long-term extension study was safety and tolerability, with biomarker data as an exploratory endpoint. The results were presented at the International Conference on Alzheimer’s and Parkinson’s Diseases held in Gothenburg, Sweden from March 28 – April 1. In patients with Alzheimer’s disease, tau protein can form "tangles" which progressively accumulate in brain regions involved in cognition.2 The accumulation of pathological tau tangles has been shown to promote brain cell damage and death. BIIB080 is designed to target microtubule-associated protein tau mRNA and prevent production of tau protein. The Phase 1b trial and its open-label long-term extension study was designed to evaluate the safety and tolerability of multiple dose levels of BIIB080 in patients with mild AD. 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 results showed that BIIB080 reduced biomarkers of soluble tau in 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 long-term extension. BIIB080 impacted aggregated tau pathology as measured by PET as early as week 25 and up to the end of the LTE at week 100, including in patients who began on placebo and received BIIB080 treatment starting at week 25 in the long-term extension. By the end of the LTE, BIIB080 reduced tau pathology in all dose groups across all brain composites assessed. The Phase 2 CELIA study of BIIB080 is in progress and currently recruiting participants in the United States.

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