AgeneBio Announces First Patient Enrollment in the Phase 3 Clinical Trial to Evaluate AGB101 to Treat Amnestic Mild Cognitive Impairment Due to Alzheimer’s Disease

BALTIMORE, Jan. 17, 2019 /PRNewswire/ -- AgeneBio announced today that it has enrolled its first patient in a Phase 3 clinical trial evaluating the efficacy of AGB101, a once-a-day investigational medication to treat amnestic Mild Cognitive Impairment due to Alzheimer’s Disease (MCI due to AD). The clinical trial, known as “HOPE4MCI” (www.hope4mci.org) will enroll 830 patients in the United States, Canada and Europe.

“We are very excited to have commenced the next phase of development on this novel approach to addressing the looming global public health crisis presented by Alzheimer’s Disease,” said Richard Mohs, Principal Investigator on AgeneBio’s HOPE4MCI clinical trial. “We have been extremely encouraged by the number of people who have expressed interest in participating in this trial.”

Accumulated scientific evidence in the field has demonstrated that neural overactivity drives both amyloid and tau pathophysiology in the brain. The HOPE4MCI study builds on an earlier Phase 2 clinical trial[1] that evaluated the efficacy of AGB101 on reducing hippocampal overactivity and on improving episodic memory, the earliest memory impairment in MCI due to AD. Cognitive and functional efficacy in the HOPE4MCI study will be measured by the Clinical Dementia Ratings Scale – Sum of Boxes (CDR-SB) (primary endpoint), Mini Mental State Exam and Functional Activities Questionnaire (MMSE, FAQ).

The HOPE4MCI trial also includes a sub-study of specialized imaging to track the pathology in the brain throughout the trial. Secondary imaging endpoints include measures of neurodegeneration (structural MRI, Tau PET). The use of [¹⁸F]MK-6240 scanning for tau, developed by Cerveau Technologies, together with a structural brain analysis developed in collaboration with the Johns Hopkins Center for Imaging Science, will trace the spread of pathology over the length of the clinical protocol and its potential modification by therapeutic treatment.

“We are pleased to be at the forefront of a new direction in Alzheimer’s Disease research moving beyond amyloid directed therapeutics to target the neuronal overactivity that drives downstream pathology and memory impairment” said Sharon Rosenzweig-Lipson, Vice President of Research and Development for AgeneBio. “Based on our Phase 2 findings, we are excited about the potential for this novel therapy to provide hope for millions of people who suffer from amnestic mild cognitive impairment due to Alzheimer’s Disease with no approved treatment options.”

AgeneBio’s pipeline of therapeutic programs is based on the research of its founder Michela Gallagher, PhD, Krieger-Eisenhower Professor of Psychological and Brain Sciences at Johns Hopkins University. Dr. Gallagher is currently on leave from the university to serve as the CEO of AgeneBio, Inc. as it initiates its Phase 3 clinical trial.

About AgeneBio
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 MCI due to AD, the symptomatic pre-dementia stage of Alzheimer’s Disease. AgeneBio’s Phase 3 candidate AGB101 is the first and only therapeutic being investigated to target hippocampal overactivity to slow progression to and delay the onset of Alzheimer’s dementia. The HOPE4MCI trial is partially supported under a public/private partnership by grant funding from NIA and awards from the Alzheimer’s Drug Discovery Foundation. The HOPE4 MCI trial is registered in clinicaltrials.gov as NCT03486938. AgeneBio also has a novel GABA-A alpha5 small molecule program in late discovery stage being investigated for a spectrum of untreated conditions including aMCI, autism and schizophrenia. Learn more at www.agenebio.com and follow us on Twitter @AgeneBio.

Cautionary Note Regarding Forward-Looking Statements
Statements herein relating to the future of AgeneBio, Inc. and the ongoing development of its products are forward-looking statements. AgeneBio, Inc. cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

[1] ClinicalTrials.gov. John Hopkins University. (2017, August 21). Levetiracetam and Memory Function in Amnestic Mild Cognitive Impairment (MCI). Identifier NCT01044758. Retrieved from:
https://clinicaltrials.gov/ct2/show/study/NCT01044758?term=levetiracetam%2C+alzheimer%27s&rank=5

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