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December 15, 2015
AgeneBio Launches New HOPE4MCI Phase 3 Clinical Trial Website
Trial to Study AGB101 to Determine if it Can Slow Progression of Symptoms Associated with aMCI and Prevent or Delay Onset of Alzheimer’s Dementia
Baltimore, MD, December 15, 2015 — AgeneBio, a biopharmaceutical company developing innovative therapeutics for unserved patients battling neurodegeneration, today announced the launch of the HOPE4MCI Phase 3 clinical trial website. Designed for patients, families, caregivers and clinicians, HOPE4MCI.org provides information about the HOPE4MCI Phase 3 clinical trial, which is expected to initiate in 2016. The trial will study AGB101 to determine if it can slow the progression of symptoms associated with amnestic mild cognitive impairment (aMCI) and prevent or delay the onset of Alzheimer’s dementia.
AGB101 and the HOPE4MCI Phase 3 Trial
AgeneBio’s lead candidate, 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 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. The trial is supported in part by a grant from the National Institutes of Health’s (NIH’s) National Institute on Aging (NIA) through a public-private partnership of the NIA, AgeneBio and Johns Hopkins University. Co-principal investigators on the NIH grant areMichela 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).
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 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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