Innovative Drug Combination Addresses Neuroinflammatory Response and Amyloid-Beta Accumulation Associated with Alzheimer's Disease
AZTherapies, Inc., an advanced clinical stage pharmaceutical company developing breakthrough treatments for neurologic diseases associated with neuroinflammation and neurodegeneration, announced publication of results in Nature’s Scientific Reports supporting use of ALZT-OP1 as a therapeutic agent for Alzheimer’s disease (AD) (Zhang C, Griuc A, Hudry E, et al. Sci Rep. 2018;8:published online January 18, 2018).
ALXT-OP1 is a combination therapy that uses two re-engineered drugs, cromolyn and ibuprofen, and is being studied in a phase 3 early AD clinical trial titled, Safety and efficacy study of ALZT-OP1 in subjects with evidence of early AD (COGNITE). To date, the trial (n = 600) has screened over 900 patients, and randomized 300 subjects, who are in various stages of the trial.
Founder and Chairman of AZTherapies, Dr. David Elmaleh, noted that, "AZTherapies uses strict inclusion criteria including brain biomarkers and measures of cognition and function to increase the accuracy of early AD diagnosis and homogeneity of randomized subjects for the COGNITE trial."
The article by Zhang and others showed that both cromolyn and cromolyn with ibuprofen almost completely rid mice of insoluable forms of amyloid-beta (Aß), which is the protein forming plaques and thought to cause neuroinflammation in AD. Their results also showed that cromolyn and cromolyn plus ibuprofen, but not ibuprofen alone, increased the number of microglial cells involved in clearing Aß from the extracellular space through phagocytosis. Recruitment of microglial cells to Ab clearing essentially induced a neuroprotective activation state of microglia that diminished both Aß accumulation and overall inflammation.
President and Chief Medical Officer with AZTherapies, Karen Reeves, MD, said, “Increasing evidence points to the important role that neuroinflammation plays in cognitive decline in Alzheimer's and other neurodegenerative disorders. Innovative treatments for these devastating diseases need a multiaction strategy including modulating the microglial cells, the specialized immune cells of the brain, to enhance neuroprotection."