BALTIMORE, Dec. 8, 2015 /PRNewswire/ -- AgeneBio, a biopharmaceutical company developing innovative therapeutics for unserved patients battling neurodegeneration, today announced the appointment of Alzheimer's drug development veteran Richard Mohs, PhD, as Vice President of Clinical Development. Dr. Mohs offers more than 30 years of experience in neuroscience clinical development and led Eli Lilly's Phase 3 development team for Alzheimer's disease drug candidates solanezumab and semagacestat. He joins AgeneBio's development team, including VP of Research and Development Sharon Rosenzweig-Lipson, PhD, and Director of Clinical Operations Steven Mulcahy.
"Richard is an eminent clinical researcher with a long and distinguished track record of expertise in Alzheimer's drug development and clinical trial design," said Jerry McLaughlin, President and CEO of AgeneBio. "His addition to our outstanding research and development team well positions AgeneBio as we rapidly advance AGB101 to our HOPE4MCI Phase 3 clinical trial."
"AGB101 is a promising drug candidate for addressing aMCI due to Alzheimer's disease – or prodromal Alzheimer's – with the potential to be the first and only therapy to address brain network imbalance that leads to memory loss and brain atrophy," said Dr. Mohs. "With multiple preclinical models demonstrating efficacy and positive Phase 2 results in hand, I look forward to working with the AgeneBio team to initiate the HOPE4MCI Phase 3 trial next year."
Most recently, Dr. Mohs served as Eli Lilly's Vice President for Neuroscience Early Clinical Development and Distinguished Research Fellow within Lilly Research Laboratories, where he led a clinical development team targeting Alzheimer's disease or other neurodegenerative diseases, pain, depression or schizophrenia. Previously, he was Professor in the Department of Psychiatry with the Mount Sinai School of Medicine and Associate Chief of Staff for Research at the Bronx Veterans Affairs Medical Center. During this time, he was instrumental in designing clinical trials that led to the approval in the US and other countries of cholinergic drug treatments for Alzheimer's disease. Dr. Mohs has served as an advisor to many neuroscience research programs at universities in the United States and to several foundations supporting neuroscience research including the John D. and Catherine T. MacArthur Foundation, the Charles A. Dana Foundation and has recently been appointed to the Board of Governors for the Alzheimer's Drug Discovery Foundation. Dr. Mohs received his PhD in psychology from Stanford University and completed postdoctoral training in pharmacology at the Stanford University Medical School.
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 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.