Phase III trial of ALZT OP1 combination therapy for early Alzheimers disease commences in US- AZTherapies

AZTherapies is commencing a Phase III clinical study of ALZT OP1, a combination drug therapy containing two previously approved drugs for other indications (cromoglicic acid and ibuprofen), for early Alzheimer's disease, after having received a Special Protocol Assessment agreement notice from the FDA. The trial expects to be actively recruiting patients in more than 10 countries, including the US, by the end of 2015.

This combination therapy will be tested in patients with early signs of dementia due to suspected Alzheimer's disease. These two drugs, which have excellent safety and tolerability profiles, are being repurposed using novel technology licensed from Massachusetts General Hospital and further developed by the company, to slow cognitive loss and potentially prevent the onset of dementia due to AD.

In June 2015, the Company completed a pharmacokinetic study for both drugs in blood and cerebrospinal fluid in 24 age matched normal control subjects following administration of a single and a two single dose of each of the drugs. The company has initiated the Phase III study in the US and Australia and is planning to initiate the study in Europe.