AgeneBio, a US-based CNS biopharma company, enrolled the first patient in a phase 3 clinical trial to study the efficacy of AGB101 for the treatment of amnestic Mild Cognitive Impairment caused by Alzheimer’s Disease (MCI due to AD).
The late-stage trial, known as HOPE4MCI, will enroll a total of 830 patients, aged between 55 and 85 years, in the US, Canada, and Europe.
The HOPE4MCI trial will evaluate the efficacy and safety of AGB101 to determine if it can slow the progression of symptoms associated with MCI due to AD and prevent or delay the start of Alzheimer’s dementia. This will be the primary objective of the late-stage clinical trial in which the enrolled patients will be randomly grouped to receive placebo or 220mg of AGB101, daily once for 78 weeks.
Currently, there is no approved treatment for MCI due to AD.
AgeneBio said that the HOPE4MCI clinical trial consolidates on a previously held phase 2 clinical trial that evaluated the efficacy of AGB101 on curtailing hippocampal overactivity and on enhancing episodic memory, the earliest memory impairment in MCI due to AD.
Also included in the HOPE4MCI trial is a sub-study of specialized imaging to track the pathology in the brain throughout the late-stage clinical trial.
Secondary imaging endpoints are measures of neurodegeneration such as structural MRI, Tau PET and others.
Sharon Rosenzweig-Lipson – Vice President of Research and Development for AgeneBio said: “We are pleased to be at the forefront of a new direction in Alzheimer’s Disease research moving beyond amyloid directed therapeutics to target the neuronal overactivity that drives downstream pathology and memory impairment.
“Based on our Phase 2 findings, we are excited about the potential for this novel therapy to provide hope for millions of people who suffer from amnestic mild cognitive impairment due to Alzheimer’s Disease with no approved treatment options.”
AgeneBio claims AGB101 to be the first and only product candidate that addresses brain network imbalance that results in memory loss and brain atrophy.
AGB101, which is a daily once, extended-release formulation of the FDA approved antiepileptic drug levetiracetam, is intended to be given to patients at nearly 1/12 of the usually prescribed dose for epilepsy.
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