NIH Awards $7.5 Million Grant for AgeneBio HOPE4MCI Phase 3 Clinical Trial to Delay the Onset of Alzheimer's Dementia

BALTIMORE, Sept. 15, 2015 /PRNewswire/ -- AgeneBio, a biopharmaceutical company developing innovative therapeutics for unserved patients battling neurodegeneration, announced today that its HOPE4MCI Phase 3 clinical trial has received support from the National Institutes of Health (NIH). The five-year, estimated $7.5 million grant initiates a public-private partnership among the NIH's National Institute on Aging, Johns Hopkins University, and AgeneBio to study AGB101and its potential to prevent or delay the onset of Alzheimer's dementia. The HOPE4MCI Phase 3 trial is the first and only trial to reduce hippocampal overactivity during amnestic mild cognitive impairment (aMCI), the symptomatic pre-dementia stage of Alzheimer's, and is expected to begin in early 2016.

AGB101 and the HOPE4MCI Phase 3 Trial
AGB101 is a proprietary once-a-day low-dose formulation of levetiracetam, an anti-epileptic treatment commercialized for more than a decade with a well-characterized safety profile at daily doses greater than twelve times the intended dose for AGB101. Phase 2 clinical results showed that AGB101 restored brain network function and significantly improved memory in elderly patients with aMCI. AgeneBio expects to initiate the HOPE4MCI Phase 3 trial in early 2016 utilizing a primary endpoint that is aligned with recent US Food and Drug Administration (FDA) guidance for aMCI trials. If approved, AGB101 would be the first and only therapeutic that reduces hippocampus overactivity and potentially the first therapeutic to prevent or delay the onset of Alzheimer's dementia. Co-principal investigators on the NIH grant are Michela Gallagher, PhD, Krieger-Eisenhower Professor of Psychological and Brain Sciences and Director of the Neurogenetics and Behavior Center at Johns Hopkins University and AgeneBio founder, and Marilyn Albert, PhD, Professor of Neurology and Director of the Division of Cognitive Neuroscience in the Department of Neurology at Johns Hopkins University School of Medicine and Director of the Johns Hopkins Alzheimer's Disease Research Center (JHADRC).

Dr. Gallagher noted, "The state of the science points to hippocampal overactivity in aMCI as a strong predictor of progression to Alzheimer's dementia and the earliest point at which this pre-dementia condition can be diagnosed before significant irreversible neurodegeneration kills brain cells. We expect our upcoming trial to demonstrate efficacy in preserving cognition and memory in aMCI patients while delaying progression to the clinical stage of Alzheimer's dementia."

"We believe our novel approach to delaying the onset of Alzheimer's dementia by targeting aMCI offers promising hope to solving this medical crisis facing millions of patients and their families," said AgeneBio President and CEO Jerry McLaughlin. "HOPE4MCI is now among an elite group of Alzheimer's prevention public-private partnership trials funded by the NIH, which is committed to advancing clinical programs targeting this devastating disease. If approved, we believe this groundbreaking therapy offers both a significant commercial opportunity and enormous social value with a substantial positive public health impact."  

NIH-Funded Alzheimer's Prevention Public-Private Partnerships
The HOPE4MCI trial grant is part of the NIH's National Institute on Aging National Plan to Address Alzheimer's Disease, which is charged with preventing or effectively treating Alzheimer's disease by 2025. Through its public-private partnership grants, NIH hopes to find solutions and treatments for some of the greatest health challenges facing Americans by bringing together private business ventures, academic institutions and government entities. NIH conducts rigorous scientific peer reviews to vet potential trials for its public-private partnership grants. In addition to the HOPE4MCI trial, other NIH-funded public-private partnerships for the prevention of Alzheimer's disease include the Alzheimer's Prevention Initiative Trials (Banner Alzheimer's Institute and Genentech), the A4 Trial (between the Alzheimer's Disease Cooperative Study and Eli Lilly) and the ApoE4 Prevention Trial (Banner Alzheimer's Institute and Novartis).

About aMCI, the Pre-Dementia Stage of Alzheimer's Disease
aMCI is a clinical condition between normal aging and early Alzheimer's dementia characterized by impaired memory. There is no treatment for aMCI, sometimes referred to as the pre-dementia stage of Alzheimer's disease, and most patients progress to Alzheimer's dementia within seven to 10 years. Today 5.6 million Americans and 25 million people globally suffer from aMCI, and this population will double by 2030. By age 85, one of every three people will have Alzheimer's disease. Alzheimer's disease currently costs Medicare and Medicaid $150 billion in direct medical costs annually, which are expected to exceed $1 trillion by 2050. Data from the Alzheimer's Association suggests that a five-year delay in the onset of Alzheimer's dementia would reduce its prevalence by more than 40%.

About AgeneBio
AgeneBio, Inc., is a development-stage CNS biopharmaceutical company developing innovative therapeutics aimed at preserving and restoring brain function for unserved patients afflicted with neurological and psychiatric diseases. AgeneBio's novel pipeline of therapies is based on decades of research at Johns Hopkins University and leading research centers worldwide showing that overactivity in the hippocampus contributes to cognitive impairment and drives neurodegeneration if not controlled. This overactivity is a characteristic feature of amnestic mild cognitive impairment (aMCI), the symptomatic pre-dementia stage of Alzheimer's disease. If approved, AgeneBio's Phase 3-ready lead candidate AGB101 will be the first and only therapeutic targeting hippocampal overactivity and potentially the first therapeutic to slow progression to and delay the onset of Alzheimer's dementia. AgeneBio expects to initiate the HOPE4MCI Phase 3 clinical trial of AGB101 in early 2016. AgeneBio also has a novel GABA-A alpha5 small molecule program in late discovery stage with therapeutic potential for a spectrum of untreated conditions including aMCI, autism and schizophrenia. Learn more at www.agenebio.com and follow us on Twitter @AgeneBio.

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SOURCE AgeneBio, Inc.

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