Product Development Pipeline

Our platform includes numerous CNS technologies. In addition to the ALZT-OP1 clinical program, we are developing a pipeline of additional disease modifying, small molecule therapies for Alzheimer’s disease and other neurodegenerative conditions such as Parkinson’s disease and cognitive impairment resulting from amyloidosis and stroke. We are also pursuing preclinical studies of our ALZT-QoL (quality of life) and ALZT-Patch product candidates and our AZHALER-D single dose disposable inhalation device.

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Our Alzheimer’s Program

Built around technology exclusively licensed from Harvard Medical School and Massachusetts General Hospital, our lead product candidate (ALZT-OP1) is a novel combination drug regimen to halt Alzheimer’s disease early in its development, by (1) inhibiting amyloid-beta (Αβ) protein aggregates that intoxicate neurons and block their signaling, and (2) by treating inflammation in the brain that triggers nerve death and progressive brain damage. We are also pursuing preclinical studies of our ALZT-QoL (quality of life) product candidate, to lessen the impact of the disease in patients with moderate to severe disease, and ALZT-Patch product candidate, to facilitate drug regimen dosing and compliance.

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Cutting-Edge Research

Our research has centered around the triggers of Alzheimer’s disease progression, namely the amyloid-beta peptides (AB40 & AB42) are cleaved from the native human amyloid precursor protein (APP) by the BACE protease and by g-secretase. Besides accumulating into amyloid fibrils and plaques within the brain, the mis-folded (aggregated) amyloid-beta peptides accumulate in neuronal synapses to initiate neurotoxicity and the formation of tau tangles inside of the neurons.

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About AZTherapies

We are a clinical stage drug development company developing next generation therapies to treat Alzheimer’s Disease and other neurodegenerative diseases. Our lead product candidate, ALZT-OP1, is a combination therapy utilizing two small molecule drugs previously approved by the United States Food and Drug Administration. We have prosecuted intellectual property on the repurposing, dosing, combination and delivery of the technology. Our in-vitro, in-vivo in APP/PS1 animal animal model and Phase I clinical results support our drug combination mechanism utility of attacking the complex neurodegeneration process associated with aging. These studies indicate that they have the potential to halt Alzheimer’s disease early in its development. We have initiated a Phase III clinical trial of ALZT-OP1 in patients with symptoms of early Alzheimer’s disease under a Special Protocol Assessment, or SPA, agreement with the FDA. Our goal is to complete this trial and be in a position to submit a New Drug Application, or NDA, by 2018.

Our Pipeline

We are also developing a pipeline of other disease modifying treatments for Alzheimer’s disease and for other neurodegenerative conditions such as Parkinson’s disease and cognitive impairment resulting from stroke. We intend to initiate a Phase II clinical trial to evaluate the safety and efficacy of our ALZT-OP1a product candidate as an adjunct, or adjuvant, treatment in subjects with post-ischemic stroke cognitive impairment, or PSCI. We are also pursuing preclinical studies of our ALZT-QoL and ALZT-Patch product candidates and our AZHALER-D single dose disposable inhalation device.