BALTIMORE, Nov. 6, 2015 /PRNewswire/ -- AgeneBio, a biopharmaceutical company developing innovative therapeutics for unserved patients battling neurodegeneration, today announced results of a crossover food effect study of its novel low-dose extended-release, once-daily formulation of AGB101 at the 8th Clinical Trials on Alzheimer's Disease (CTAD) in Barcelona. AgeneBio Vice President of Research and Development Sharon Rosenzweig-Lipson, PhD, presented "Pharmacokinetic Profile of a Novel Low Dose Extended Release Formulation of AGB101 (Levetiracetam)." The study showed that AgeneBio's proprietary dose and formulation are suitable for use in the upcoming HOPE4MCI Phase 3 clinical trial in amnestic mild cognitive impairment (aMCI) patients. AGB101 is the company's lead product candidate that targets the large unserved aMCI patient population. If approved, AGB101 will be the first and only therapeutic targeting hippocampus overactivity and potentially the first therapeutic to slow progression to, and delay the onset of, Alzheimer's dementia.
The study showed that sustained plasma levels of levetiracetam consistent with AGB101 Phase 2 efficacy were observed over a 14-hour period. Further, the PK profile of AGB101 was consistent with an extended-release formulation suitable for once-daily dosing. Additionally, the study showed that there were no food effects on Cmax or AUC. The study authors concluded that the AGB101 low-dose, extended-release formulation of AGB101 is suitable for use in the upcoming HOPE4MCI Phase 3 clinical trial in aMCI. Complete study results are available on AgeneBio's website on the Publications page.
"With these pharmacokinetic results in hand, we are well-poised to initiate the HOPE4MCI Phase 3 clinical trial in 2016 with our low-dose, once-a-day proprietary AGB101 formulation," said Dr. Rosenzweig-Lipson. "Once-a-day dosing is clinically important for improving compliance in the treatment of aMCI, as these patients struggle with memory impairment. We expect our upcoming trial to demonstrate efficacy in preserving cognition and memory in aMCI patients while delaying progression of the underlying disease pathophysiology."
Additionally at CTAD, AgeneBio Founder and Scientific Advisor Michela Gallagher, PhD, and Dr. Rosenzweig-Lipson presented "Clinical Trial in MCI Reducing Hippocampal Overactivity: HOPE4MCI," regarding AgeneBio's upcoming Phase 3 trial, a landmark public-private partnership supported by the National Institutes of Health's National Institute on Aging, AgeneBio and Johns Hopkins University.
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).
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.