AgeneBio announced two grant awards to advance their approaches to slowing progression of mild cognitive impairment (MCI) due to Alzheimer's Disease (AD). The grants were awarded by the National Institute of Aging (NIA) and the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH).
"We are grateful to the NIA for the award supporting our Phase 3 clinical trial for AGB-101 and the significant additional BPN resources to help advance AgeneBio's neurotherapeutics that hold so much promise to stem the spread of this looming public health crisis," said Dr. Michela Gallagher, AgeneBio's CEO.
The NIH clinical award partially funds a Phase 3 clinical trial of a therapeutic to treat patients with MCI due to AD, characterized by progressive premature memory impairment. Accumulated scientific evidence in the field has demonstrated that neural overactivity drives both amyloid and tau pathophysiology in the brain. The HOPE4MCI trial will include a sub-study of specialized imaging to track the pathology in the brain throughout the trial. The use of [18F]MK-6240 scanning for tau, developed by Cerveau Technologies, together with a structural brain analysis developed in collaboration with the Johns Hopkins Center for Imaging Science, will trace the spread of pathology over the length of the clinical protocol and its potential modification by therapeutic treatment.
"The support for this pivotal trial recognizes the scientific potential to delay the onset of Alzheimer's dementia by targeting the marked hippocampal overactivity that is present during MCI due to AD. We look forward to furthering our program with this tremendous support," said Richard Mohs, Principal investigator on AgeneBio's HOPE4MCI clinical trial.
"This funding is an example of a non-amyloid treatment," said Laurie Ryan, Ph.D., chief of the Dementias of Aging Branch, and program director for Alzheimer's Disease Clinical Trials in NIA's Division of Neuroscience. "It shows our commitment to develop therapies across the range of disease."
NIA has also awarded a grant to support AgeneBio's novel GABA-A a5 therapeutic small molecule program to normalize brain function in early stages of Alzheimer's disease. The BPN grant is supported by the NIH Blueprint for Neuroscience Research, a collaboration of NIH Institutes and Centers that supports research on the nervous system. As part of the BPN program, AgeneBio receives access to chemistry, ADME, safety and clinical CROs to further advance the GABA-A a5 program. The UH3 grant, led by Dr. Rosenzweig-Lipson, follows successful completion of critical chemistry and in vivo efficacy milestones during the initial UH2 Hit-to-Lead phase of the program.
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