AgeneBio Receives NIH Grant to Initiate Phase 3 HOPE4MCI Trial to Treat MCI Due to Alzheimer's Disease

BALTIMORE, Sept. 19, 2017 /PRNewswire/ -- AgeneBio, a pharmaceutical company developing innovative therapeutics for unserved patients battling neurodegeneration, today announced it has been awarded a grant from the National Institute on Aging (NIA) of the National Institutes of Health (NIH) to support its Phase 3 HOPE4MCI clinical trial for AGB101. AGB101 is the first and only therapeutic for mild cognitive impairment due to Alzheimer's disease (MCI due to AD) targeting brain network imbalance and potentially the first therapeutic to slow progression to, and delay the onset of, Alzheimer's dementia. MCI due to AD is an intermediate stage between normal cognition and Alzheimer's dementia in which memory and cognitive abilities are markedly worse than expected for a person's age. This grant builds on the previous NIH grant for the HOPE4MCI trial that established a public-private partnership among the NIA, Johns Hopkins University, and AgeneBio for the HOPE4MCI trial.   

"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," said Richard Mohs, PhD, AgeneBio's Vice President of Clinical Development and Principal Investigator for this NIH award. "We expect the HOPE4MCI trial to demonstrate efficacy in preserving cognition and memory in MCI due to AD patients while delaying progression to the clinical stage of Alzheimer's dementia."

"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 that is present during MCI due to AD," said AgeneBio's founder and Chief Scientific Officer, HOPE4MCI Principal Investigator, and Krieger-Eisenhower Professor of Psychological and Brain Sciences at Johns Hopkins University, Michela Gallagher, PhD.

"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, PhD, 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."

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 MCI due to AD. The HOPE4MCI Phase 3 trial will utilize a primary endpoint that is aligned with US Food and Drug Administration (FDA) guidance for MCI due to AD trials. If approved, AGB101 would be the first and only therapeutic for MCI due to AD that reduces hippocampus overactivity and potentially the first therapeutic to prevent or delay the onset of Alzheimer's dementia.

About MCI due to AD, the Pre-Dementia Stage of Alzheimer's Disease

MCI due to AD is a clinical condition between normal aging and early Alzheimer's dementia characterized by impaired memory. There is no treatment for MCI due to AD, 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 MCI due to AD, 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 could 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 mild cognitive impairment due to Alzheimer's disease (MCI due to AD), 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 also has a novel GABA_A a5 small molecule program in discovery stage with therapeutic potential for a spectrum of untreated conditions including MCI due to AD, autism and schizophrenia. Learn more at www.agenebio.com and follow us on Twitter @AgeneBio.

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SOURCE AgeneBio