US-based pharmaceutical firm AgeneBio is set to investigate its therapeutic agent AGB101 in a Phase III clinical trial (HOPE4MCI) for the treatment of mild cognitive impairment due to Alzheimer’s disease (MCI due to AD).
The National Institutes of Health (NIH) National Institute on Aging (NIA) has awarded a grant to support the Phase III trial.
The grant follows another NIH grant that led to a collaboration between NIA, Johns Hopkins University, and AgeneBio for the HOPE4MCI trial.
AGB101 is a once-a-day, low-dose formulation of an anti-epileptic, levetiracetam currently being developed to target brain network imbalance and slow progression or delay the onset of Alzheimer’s dementia.
Planned to begin enrolment in the first quarter of next year, the Phase III trial is expected to effectively preserve cognition and memory, as well as delay progression to the clinical stage of the dementia in patients with MCI due to AD.
AgeneBio research and development vice-president Sharon Rosenzweig-Lipson said: “The state of the science points to hippocampal overactivity in MCI due to AD as a strong predictor of progression to Alzheimer’s dementia and the earliest point at which this pre-dementia condition can be diagnosed and potentially treated before significant irreversible neurodegeneration occurs.
“This continued support of our R&D portfolio from the NIH enables us to advance AGB101 into Phase III as we continue to develop our earlier stage programmes that target the same detrimental brain network dysfunction.”
The primary endpoint of the trial will be according to the guidance issued by the US Food and Drug Administration (FDA) for MCI due to AD trials.
In Phase II trials, AGB101 is reported to have restored brain network function and improved memory in elderly patients with MCI due to AD.