Boston-based AZTherapies says that it plans to initiate a Phase 3 study of its ALZT-OP1, an inhaled combination product for the prevention and treatment of Alzheimer’s disease, by the end of 2014 now that it has gotten the go-ahead from the FDA. Both drugs used in the combination therapy are already approved in the US, and the company plans to use data from the trial to support a 505(b)(2) NDA.
AZTherapies board member Peter Conti, a Professor of Radiology, Biomedical Engineering and Pharmaceutical Sciences at the University of Southern California, said, “The company technology includes intellectual property protecting the drug combination, dosing, formulation and drug properties that will deliver the drug to both blood and brain through inhalation.”
According to the company, the drugs involved “are being repurposed using novel technology licensed from MGH [Massachusetts General Hospital] and further developed in the company, to slow cognitive loss or prevent the onset of dementia due to AD.”
Read the AZTherapies press release.