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news.The US Food and Drug Administration (FDA) has granted approval to AZTherapies to proceed with the Phase III clinical trial submitted in its Investigational New Drug (IND) application.
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The company develops new treatments for Alzheimer’s disease (AD) based on technology licensed from Massachusetts General Hospital.
The trial is for the company’s lead program, ALZT-OP1, a new multifunctional drug combination therapy for the prevention and treatment of early AD.
ALZT-OP1 includes administration of two previously approved drugs that act on important mechanisms relevant to AD, with a new formulation and targeted delivery to ensure blood and brain concentrations necessary to achieve their actions.
According to the company, drug A inhibits beta-amyloid peptide polymerization and drug B inhibits the neuro-inflammatory response in patients with amnestic mild cognitive impairment (aMCI) due to suspected AD.
The two drugs are being repurposed using a new technology licensed from MGH and further developed in the company, to slow cognitive loss or prevent the onset of dementia due to AD.
Currently, the company is underway to start the study, ‘A Phase III Safety and Efficacy Study of ALZT-OP1 in Subjects with Evidence of Amnestic Mild Cognitive Impairment due to Suspected Alzheimer’s Disease’ by the fourth quarter of 2014.
The trial would be conducted in upwards of ten countries around the world, including the US.