Creating Novel Treatments For Neurodegeneration and Neuroinflammation
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.
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.