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AgeneBio Inc

Sharon Rosenzweig-Lipson, PhD | Maryland, United States

AgeneBio Inc

Sharon Rosenzweig-Lipson, PhD | Maryland, United States

Accelerating a Phase III MCI Clinical Trial with Phase I Evaluation of a Novel Extended-Release Levetiracetam Formulation

Amnestic mild cognitive impairment (aMCI), a condition in which memory is worse than expected for a person's age, is recognized as an early stage of Alzheimer's disease with high risk of progression to dementia. Currently there is no FDA approved therapeutic treatment for aMCI that has shown either the ability to improve the cognitive symptoms of aMCI or the worsening of that condition. AgeneBio, Inc. has advanced a clinical program to 'slow progression in mild cognitive impairment (MCI) due to Alzheimer's disease (AD)' using the first treatment to target hippocampal hyperactivity, which is characteristic of the aMCI stage of the disease and predicts progression in patients, including conversion to a diagnosis of dementia. The company is preparing to launch a Phase III trial of AGB101. AGB101 is a low dose formulation of levetiracetam, an atypical antiepileptic drug with a very favorable safety profile, which has demonstrated therapeutic benefit in both animal models and in a proof-of-concept study in aMCI patients. The current application seeks to accelerate the start of an FDA approved Phase III program of this repurposed compound with an extended release once-a-day medication of AGB101. Funding requested under this application will be used to accelerate the steps in developing the formulation matching the exposures for efficacy observed the proof of concept study in aMCI. This formulation is expected to optimize benefit in the treatment of patients participating in the clinical Phase III trial and accelerate the ability to provide the drug to patients in the event of a successful FDA Phase III program.