AgeneBio recently announced that recent research suggesting levetiracetam may prevent amyloid-beta plaque formation in early-stage Alzheimer’s disease further validates the company’s approach to treating cognitive impairment associated with neurodegenerative disorders. The Baltimore-based clinical-stage biopharmaceutical company retains exclusive rights to a low-dose, extended-release formulation of levetiracetam designed specifically for treating mild cognitive impairment due to Alzheimer’s disease.
The newly published research from Northwestern University found that levetiracetam prevented the formation of amyloid-beta plaques in preclinical models of Alzheimer’s disease. These findings support a potential disease-modifying mechanism for levetiracetam and add to growing scientific interest in targeting early neuronal hyperactivity as a driver of disease progression.
AgeneBio holds issued patents covering proprietary once-daily extended-release formulations of levetiracetam, including AGB101. The company’s formulation is designed to provide stable drug exposure within a well-characterized narrow therapeutic window for chronic use in patients with mild cognitive impairment due to Alzheimer’s disease.
AgeneBio previously published results from an 18-month phase 2b human clinical trial conducted by Mohs et al. (2024) and Bakker et al. (2024), which showed that AGB101 demonstrated a trend toward reducing cognitive decline in a subset of patients with mild cognitive impairment due to Alzheimer’s disease. The study also reported a statistically significant reduction in neuronal atrophy in Alzheimer’s disease patients receiving AGB101.
According to the company, AGB101’s differentiated pharmacokinetic profile, enabled by its patent-protected once-daily formulation, positions AgeneBio uniquely within the levetiracetam space for the early treatment of neurodegenerative disorders. AgeneBio retains exclusive rights to the formulation and associated therapeutic approach.
The company said it continues to evaluate strategic and development pathways for AGB101, including potential partnerships, regulatory engagement, and further clinical investigation. AGB101 remains investigational and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority for the treatment of Alzheimer’s disease.
AgeneBio focuses on developing therapies that address early drivers of neurodegenerative disease. Its lead program, AGB101, is a patented once-daily extended-release formulation of levetiracetam designed for patients with mild cognitive impairment due to Alzheimer’s disease.
This announcement contains forward-looking statements regarding the potential therapeutic benefits of AGB101, future development plans, regulatory strategy, intellectual property protection, and business strategy. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. The company undertakes no obligation to update these statements except as required by law.
KEY QUOTES
“These Northwestern findings extend the biological rationale and observed biological data behind our program. We designed AGB101 to address neuronal hyperactivity early in the disease process. Independent data suggesting levetiracetam may also influence amyloid biology from this study and others strengthen the scientific foundation of AgeneBio’s novel approach to treating cognitive impairment in CNS disorders in their earliest stages.”
Dr. Michela Gallagher, Founder & Chief Executive Officer, AgeneBio
