AGB101 is in development to treat amnestic mild cognitive impairment (aMCI) and to delay progression to Alzheimer’s dementia.
The first and only therapeutic targeting brain network imbalance and potentially the first therapeutic to slow progression to, and delay the onset of, Alzheimer’s dementia
- Phase 3-ready candidate targeting a large unserved patient population with aMCI due to Alzheimer’s disease (or prodromal AD), the earliest symptomatic stage characterized by memory loss
- No approved treatments for the 5.6 million US aMCI patients (25 million worldwide)
- First and only product candidate addressing brain network imbalance that leads to memory loss and brain atrophy
- HOPE4MCI Phase 3 clinical program to be initiated in 2017
Learn more about the HOPE4MCI Phase 3 clinical trial.
AGB101 Designed to Delay Alzheimer’s Dementia
Based on clinical research results 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. Learn more about aMCI and Alzheimer’s dementia.
Advantages of Our AGB101 Development Program
Intervening Early in the Disease Process
AGB101 is being studied for aMCI, the symptomatic, pre-dementia stage of Alzheimer’s. aMCI represents a period of initiation of marked changes in both brain function and memory, providing the best stage of the disease in which to measure efficacy. Currently, FDA-approved treatments are indicated to provide symptomatic relief much later in the disease process when it is too late for patients as there is substantial neuronal cell death. Some companies are studying product candidates years prior to any symptoms. Unfortunately, the length of time and probability of progressing from an asymptomatic stage to Alzheimer’s is fairly unpredictable.
Known Molecule at a Fraction of the Dose
AGB101 is proprietary once-daily, extended-release formulation of levetiracetam, an FDA-approved anti-epileptic, given to patients at approximately one-twelfth of the dose most commonly prescribed for epilepsy. Levetiracetam has been commercialized for 17 years with a well-characterized safety profile at 12 times the expected dose for AGB101.
Consistent Study Results
The positive results of the AGB101 Phase 2 trial—restored brain function and memory—were consistent with preclinical models. The successful and highly consistent translation from animal data to a human clinical trial of patients with aMCI suggests that the clinical efficacy profile for AGB101 is robust and predictable. We expect to initiate the pivotal Phase 3 clinical trial in 2017.