AgeneBio Announces Two NIH Grant Awards to Advance its Therapeutic Pipeline to Combat Progression of Alzheimer's Disease

- NIH awards an expected $16 million to support Phase 3 pivotal clinical trial of AGB-101, a once-a-day treatment to slow progression in Mild Cognitive Impairment due to Alzheimer's disease.
- NIH awards follow on funding from the Blueprint Neurotherapeutics (BPN) Network Program to support development of GABA-A a5 small molecule program targeting hippocampal overactivity.

BALTIMORE, Oct. 9, 2018 /PRNewswire/ -- AgeneBio, a development-stage CNS biopharmaceutical company with a novel pipeline for neurological and psychiatric diseases addressing significant unmet medical needs, today 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).

AGENEBIO (PRNewsfoto/AgeneBio)

"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."

Sharon Rosenzweig-Lipson, Vice President of Research and Development stated, "Previous support by NIA has already enabled us to complete study start up activities for the HOPE4MCI trial.  The new grant will allow us to rapidly begin enrollment in the trial putting us one step closer to understanding the impact of hippocampal overactivity and tau pathology in this disease and to being able to treat MCI due to AD."

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.

AgeneBio's pipeline of therapeutic programs is based on the research of its founder Michela Gallagher, PhD, Krieger-Eisenhower Professor of Psychological and Brain Sciences at Johns Hopkins University. Dr. Gallagher is currently on leave from the university to serve as the CEO of AgeneBio, Inc. as it initiates its Phase 3 clinical trial.

NIH awards reported in this press release are grants numbered R01AG061091and UH3NS101856. Clinical trial number: NCT03486938. This content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

AgeneBio is a development-stage CNS biopharmaceutical company with a novel pipeline for neurological and psychiatric diseases addressing significant unmet medical needs. The company's lead asset, AGB101, is in development for mild cognitive impairment due to Alzheimer's disease (MCI due to AD), the earliest symptomatic stage of AD. The company also has a late discovery stage program (GABA-A a5 positive allosteric modulator program) with potential in Alzheimer's disease, schizophrenia, and autism. The company's lead program, AGB101, modulates synaptic neurotransmitter release in the hippocampus by binding to synaptic vesicle protein SV2A. Based on Phase 2a clinical research results to date, AGB101 restores normal brain network function and preserves memory in patients with mild cognitive impairment due to Alzheimer's disease (MCI due to AD), the earliest symptomatic stage of Alzheimer's and may prevent or delay the onset of Alzheimer's dementia. AGB101 is well- positioned, pending Phase 3 clinical results and FDA approval, to make a tremendous difference in the lives of patients and society as a whole.

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