AgeneBio secures ADDF grant for new approach to delaying onset of Alzheimer’s Dementia

AgeneBio is developing AGB101, a Phase-3 ready candidate targeting a large unserved aMCI patient population. If approved, AGB101 will be the first and only therapeutic that targets hippocampus overactivity, and potentially the first therapeutic to slow progression to, and delay the onset of, Alzheimer’s dementia. This is the second grant to AgeneBio from the ADDF.

AGB101 is a proprietary formulation of low-dose levetiracetam, given to patients at approximately one-fifteenth of the dose most commonly prescribed for epilepsy. This therapeutic has been commercialized for more than a decade and offers a well-characterized safety profile at fifteen times the expected dose for AGB101. AgeneBio expects to initiate the AGB101 Phase 3 clinical program in the second half of 2015.

"The ADDF is thrilled to support AgeneBio to advance the clinical development of this drug candidate for the benefit of aMCI patients," said the ADDF’s Founding Executive Director and Chief Science Officer Howard Fillit, MD. "This treatment has the potential to alter the course of Alzheimer’s disease, restore normal brain function and preserve memory and cognitive abilities."

"Decades of research and Phase 2 clinical results show that intervening during aMCI, the symptomatic pre-dementia stage of Alzheimer’s, offers the very best prospect to prevent and delay disease progression," said AgeneBio CEO Jerry McLaughlin.

"Based on clinical research to date, we believe AGB101 restores normal brain function and preserves memory in patients and has the potential to delay the onset of Alzheimer’s dementia. If approved, AGB101 offers both a significant commercial opportunity and momentous social value to patients and families battling this debilitating disease."

AgeneBio’s portfolio of drug discovery work is based on the research of its founder, Michela Gallagher, PhD, Krieger-Eisenhower Professor of Psychological and Brain Sciences and Principal Investigator of the Neurogenetics and Behavior Center at Johns Hopkins University.

Today 5.6 million Americans and 25 million people globally suffer from amnestic mild cognitive impairment (aMCI), the symptomatic, pre-dementia stage of Alzheimer’s disease characterized by significant loss of memory, 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 with the cost expected to exceed $1 trillion by 2050. Data from the National Institute on Aging show that modest delays have massive benefits to patients, their families, and society as a whole.

If the onset of Alzheimer’s dementia can be delayed, there is an approximately 10% reduction in the prevalence of this disease for every one-year delay in the onset of Alzheimer’s dementia.