Creating Novel Treatments For Neurodegeneration and Neuroinflammation

Product Development Pipeline

Our platform comprises numerous CNS technologies. In addition to our ongoing ALZT-OP1 clinical trial, the Cognite Trial, we are developing 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 amyloidosis-related cognitive impairment, stroke, and Parkinson’s disease. 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 titrating the associated neuroinflammatory response that triggers nerve death and progressive brain damage. We are also pursuing preclinical studies of M1, a reversible acetylcholine esterase inhibitor as a quality of life product candidate, and 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, the oligomeric forms 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 an advanced clinical-stage drug development company creating the next generation of therapeutics to treat Alzheimer’s disease and other neuroinflammatory and neurodegenerative conditions. Our ongoing, Phase III Cognite Trial with ALZT-OP1, a combination therapy utilizing two small molecule drugs previously approved by the United States Food and Drug Administration. The company already has intellectual property protection (IP) protection for the platform use and actively pursuing IP protection on AD use, repurposing, dosing, combination and delivery of our novel treatment. Our in vitro, in vivo (in the APP/PS1 mouse model), and two Phase I clinical study results in normal and AD subjects support the potential efficacy of our combination therapy to combat the complex neurinflammation and 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 the Cognite Trial 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 2020.

Our Pipeline

We are also developing the next generation disease modifying treatments for Alzheimer’s disease and for other neuroinflammatory and neurodegenerative conditions such as cognitive impairment resulting from stroke and Parkinson’s disease. 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 preclinical studies of M1, a reversible acetylcholine esterase inhibitor as a quality-of-life focused drug, ALZT-QoL, the ALZT-Patch for transdermal drug delivery, and our AZHALER-D single dose disposable inhaler.