AgeneBio Obtains National Institute on Aging Grant for Phase 3 Trial of Its Alzheimer’s Therapy AGB101

AgeneBio has obtained a National Institute on Aging grant to conduct a Phase 3 clinical trial of AGB101 (levetiracetam), a compound intended to prevent people with mild memory impairment from developing Alzheimer’s disease.

The agency, part of the National Institutes of Health (NIH), has been backing the potential therapy’s development for some time. AgeneBio did not announce the size of the latest grant.

“With the award of this additional funding from the NIH, we will immediately initiate the Phase 3 trial start-up with an initial cohort of clinical sites and expect to enroll the first patient during the first quarter of 2018,” Richard Mohs, AgeneBio’s Vice President of Clinical Development, said in a press release.

The trial, called HOPE4MCI, will continue examining AGB101’s ability to slow or reverse cognitive decline.

A Phase 2 clinical trial (NCT01044758) showed that the compound improved memory performance. Researchers believe the potential therapy will also be successful in the Phase 3 study.

“We expect the HOPE4MCI trial to demonstrate efficacy in preserving cognition and memory in MCI [mild cognitive impairment] due to AD [Alzheimer’s disease] patients while delaying progression to the clinical stage of Alzheimer’s dementia,” Mohs said.

AGB101 is an updated version of an epilepsy drug that has been on the market for two decades. Its extended-release formulation is one-twelfth the dose used to stop seizures.

The treatment builds on memory processing research. It has shown that people with memory loss-based mild cognitive impairment who are at high risk of developing Alzheimer’s have abnormally high activity in a brain region called the hippocampus. That region is involved in memory processing.

The Phase 2 trial showed that AGB101 restored brain activity to a normal level. The finding supported the idea that a disturbance in the hippocampus is involved in memory impairment.

“We are grateful to the NIH for this grant that further supports our HOPE4MCI trial and recognizes the scientific potential to delay the onset of Alzheimer’s dementia by targeting the marked hippocampal overactivity,” said Michela Gallagher, AgeneBio’s founder and Chief Scientific Officer.

Gallagher, who is also the Krieger-Eisenhower Professor of Psychological and Brain Sciences at Johns Hopkins University, will be the principal investigator of the HOPE4MCI trial.

“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,” said Sharon Rosenzweig-Lipson, AgeneBio’s Vice President of Research and Development.

“This continued support of our R&D portfolio from the NIH enables us to advance AGB101 into Phase 3 as we continue to develop our earlier-stage programs that target the same detrimental brain network dysfunction,” she added.