Gallagher highlights the groundbreaking clinical trial, HOPE4MCI, which could slow progression from Mild Cognitive Impairment to Alzheimer’s dementia
LOS ANGELES, April 30, 2018 — Today, AgeneBio Founder Dr. Michela Gallagher participated in a panel discussion at the Milken Global Conference Alzheimer’s Disease: Rewriting the Playbook. The panel, hosted by Milken’s LaTese Briggs and including Todd Rainwater of the Rainwater Charitable Foundation, Lauren Miller Rogan of Hilarity for Charity and Garen Staglin of One Mind, discussed new approaches to address Alzheimer’s Disease (AD) as a burgeoning public health crisis.
Dr. Gallagher explained to those in attendance that a proactive approach of addressing Mild Cognitive Impairment (MCI) to delay the onset of dementia can have a measurable impact. She went further to say that there is hope on the horizon for prevention of dementia by targeting the earliest stages of the disease, despite the many failures of recent drug trials to treat patients with Alzheimer’s dementia.
“If you can delay progression to a diagnosis of dementia by three years you will cut the prevalence – that is the number of people with Alzheimer’s dementia – by a third,” said Dr. Gallagher. “That’s a big win.”
As one of the most daunting public health crises on the horizon, Alzheimer’s disease is soon expected to overwhelm the national healthcare system, affecting a projected 16 million Americans and costing Medicare and Medicaid over $1 trillion by 2050.
Briggs asked the panel about early failures in research that had focused primarily on amyloid molecules and plaques in the brain and the recent shift to study the role that tau molecules might play in the progression of Alzheimer’s dementia. Dr. Gallagher replied that you may not need to entirely connect all the dots of the underlying pathology.
“What we have been working with is the well established idea that neural activity drives both amyloid and tau [accumulation and damage],” Dr. Gallagher explained. “In this condition of MCI there is heightened neural activity in the specific brain circuits where the more extensive spread of pathology originates.”
Previous studies had had been based on the premise that Alzheimer’s Disease is characterized by a loss of neural activity in the brain. But recent research has shown that the earliest phases of disease prior to dementia is marked by heightened neural activity. Based on this understanding, Hopkins researchers have conducted clinical studies demonstrating that drugs, which decrease aberrant brain activity, improve cognitive performance of patients in the early MCI phase of AD. In the hope of finding a practical application for this research, Dr. Gallagher founded AgeneBio, Inc., which is currently initiating a pivotal Phase 3 trial to delay progression to Alzheimer’s dementia. Gallagher says this phase 3 trial, aptly referred to as HOPE4MCI (on clinicaltrials.gov) is the first pivotal trial to target neural overactivity, and not a repeat of the approaches that have failed to date.
“We took a drug to lower that [over]activity – which people had originally thought was compensatory,” said Dr. Gallagher. “If you bring that overactivity down in MCI patients the function of that system improves. That’s our approach. It is very much a kind of brain network approach rather than identifying which is the bad molecule.”
This solution could offer a go-to-market therapy for delaying progression to Alzheimer’s dementia. Progress in this program has been supported by a public/private partnership with the NIH and the Program to Accelerate Clinical Trials sponsored by the Alzheimer’s Drug Discovery Foundation (ADDF). The HOPE4MCI trial will test whether lowering overactivity for an 18-month duration slows progression in this transitional condition prior to the onset of clinical dementia.
ABOUT DR. MICHELA GALLAGHER
Michela Gallagher, Ph.D. is the Krieger-Eisenhower Professor of Psychology and Neuroscience and heads the Neurogenetics and Behavior Center at Johns Hopkins University. She is also founder of AgeneBio, Inc. a pharmaceutical development company initiating a Phase 3 trial to delay the progression of Alzheimer’s dementia and a late-stage discovery program of therapies for aMCI, autism and schizophrenia. She is recognized for her contributions in cognitive neuroscience as a recipient of the American Psychological Association’s D.O. Hebb award and the Society for Neuroscience Mika Salpeter Lifetime Achievement Award.
AgeneBio is a development-stage CNS biopharmaceutical company with a novel pipeline for neurological and psychiatric diseases addressing significant unmet medical needs. The company’s lead asset, AGB101, is in development for mild cognitive impairment due to Alzheimer’s disease (MCI due to AD), the earliest symptomatic stage of AD. The company also has a late discovery stage program (GABAA a5 positive allosteric modulator program) with potential in Alzheimer’s disease, schizophrenia, and autism. The company’s lead program, AGB101, modulates synaptic neurotransmitter release in the hippocampus by binding to synaptic vesicle protein SV2A. Based on Phase 2a clinical research results to date, AGB101 restores normal brain network function and preserves memory in patients with mild cognitive impairment due to Alzheimer’s disease (MCI due to AD), the earliest symptomatic stage of Alzheimer’s and may prevent or delay the onset of Alzheimer’s dementia. AGB101 is well- positioned, pending Phase 3 clinical results and FDA approval, to make a tremendous difference in the lives of patients and society as a whole.