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.
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.