Product Development Pipeline

Our platform comprises numerous CNS technologies. In addition to our ongoing ALZT-OP1 clinical trial, we are developing a new generation of additional disease modifying, small molecule therapies for Alzheimer’s disease and other neurodegenerative conditions. We are looking beyond Alzheimer’s disease to conditions such as Parkinson’s disease, amyloidosis-related cognitive impairment and stroke. We are also pursuing additional avenues of treatment, such as quality of life with our ALZT-QoL therapy as well as novel dosing and administration technologies, such as the ALZT-Patch and 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 designed to halt Alzheimer’s disease early in its development. ALZT-OP1 takes a two pronged approach to Alzheimer’s disease treatment by both inhibiting neurotoxic amyloid-beta protein aggregation and by treating the inflammation in the brain that triggers nerve death and progressive brain damage. We are also pursuing preclinical studies of our quality of life product candidate, ALZT-QoL, which will lessen the impact of Alzheimer’s in patients with moderate to severe disease. Additionally, we are developing the AZHALER-D single dose disposable inhalation device, and the ALZT-Patch to facilitate optimal drug dosing and increase patient compliance.

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Cutting-Edge Research

Our research is centered around the triggers of Alzheimer’s disease progression, namely the accumulation of amyloid-beta plaques and concomitant neuroinflammation. Amyloid-beta accumulates into fibrils and plaques in the brain, accumulating in neuronal synapses causing neurotoxicity and the formation of tau tangles inside of the neurons. This neurotoxicity is exacerbated by a heightened inflammatory response, leading to further damage to the brain.

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About AZTherapies

We are a clinical-stage drug development company creating the next generation of therapeutics to treat Alzheimer’s disease and other neurodegenerative conditions. 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 are actively pursuing intellectual property protection on the repurposing, dosing, combination and delivery of our novel treatment. Our in vitro, in vivo (in the APP/PS1 mouse model), and Phase I clinical results support the efficacy of our combination therapy at combatting the complex neurodegeneration process associated with Alzheimer’s disease. Our research shows that this therapy has the potential to halt Alzheimer’s disease early in its development. The ongoing Phase III clinical trial of ALZT-OP1 in patients with symptoms of early Alzheimer’s disease is being conducted under a Special Protocol Assessment agreement with the FDA. Our goal is to complete this trial and be in a position to submit a New Drug Application by 2018.

Our Pipeline

We are also developing the next generaion disease modifying treatments for Alzheimer’s disease and for other neurodegenerative conditions such as Parkinson’s disease and cognitive impairment resulting from stroke. We are initiating 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. We are also pursuing pre-clinical studies of our quality-of-life focused drug, ALZT-QoL, as well as the ALZT-Patch for transdermal drug delivery, and our AZHALER-D single dose disposable inhaler.