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.
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.