A new publication confirms AZTherapies's innovative drug combination approach to address the neuroinflammation response via neuro-immunology and amyloid beta accumulation associated with neurodegeneration and Alzheimer's disease.
BOSTON, Jan. 31, 2018 /PRNewswire/ -- AZTherapies, Inc. is a privately held advanced clinical stage pharmaceutical company located in Boston, MA that is developing breakthrough treatments for Alzheimer's disease (AD), ischemic stroke, and other neurological diseases associated with neuroinflammation and neurodegeneration. The lead product candidate, a combination multi-faceted treatment using two re-engineered drugs, cromolyn and ibuprofen, ALZT-OP1, is being studied in a Phase 3 Early Alzheimer's clinical trial, the COGNITE trial.
Dr. David Elmaleh, AZTherapies Founder, Chairman, and CEO said, "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 the randomized subjects for the COGNITE Trial."
The ongoing AZTherapies Phase 3 COGNITE trial (n=600) has screened over 900 patients with over 300 randomized, 128 at week 48, and 56 at week 72, study completion. (https://cognitetrial.com)
"Increasing evidence points to the important role that neuroinflammation plays in cognitive decline in Alzheimer's and other neurodegenerative disorders," said Karen Reeves, MD, President and Chief Medical Officer. "Innovative treatments for these devastating diseases need a multi-action strategy including modulating the microglial cells, the specialized immune cells of the brain, to enhance neuroprotection."
A research article, from the laboratory of Dr. Rudolph Tanzi, Joseph. P. and Rose F. Kennedy Professor of Neurology, Harvard Medical School, Vice-Chair, Neurology; Director of Genetics and Aging Research Unit, Massachusetts General Hospital, published Jan. 18, 2018 in Nature's Scientific Reports,Cromolyn Reduces Levels of the Alzheimer's Disease-Associated Amyloid β-Protein by Promoting Microglial Phagocytosis ( Zhang, Griuc, Hudry et al.; Scientific Reports (2018) 8:1144; DOI:10.1038/s41598-018-19641-2) supports the scientific rationale for using AZTherapies' drug combination to potentially slow down or halt AD progression early in its manifestation. (https://www.nature.com/articles/s41598-018-19641-2)
The Scientific Reports' article evaluated the effects of cromolyn and ibuprofen, used in the COGNITE trial, in a Tg2576 mice model of AD for early treatment effects on plaque formation and in microglial cell clearance assays on its effects on microglia activation as anti-inflammatory drugs.
The article concludes, "Collectively our data reveal robust effects of cromolyn, alone, or in combination with ibuprofen, in reducing aggregation-prone Aβ levels and inducing a microglial activation state favoring Aβ phagocytosis versus a pro-neuroinflammatory state."
AZTherapies (www.aztherapies.com) is an advanced clinical stage pharmaceutical company based in Boston, MA. AZTherapies is using innovative approaches in the discovery, development and commercialization of novel Alzheimer's Disease and ischemic stroke treatments which could fundamentally improve patient treatment, quality of life and disease management. The company's lead program, ALZT-OP1, is a combination therapy comprising two re-engineered drugs with well-characterized safety profiles with intellectual property protecting drug combination, dosing, formulation and drug properties that will deliver the drugs to the blood and brain. The company platform also includes ALZT-OP2, a potential disease modifying AD drug treatment in advanced preclinical development, AZHALER-D, a single dose disposable novel inhaler in late stage development, and ALZT-QoL, a neurodegenerative drug treatment designed to improve the quality of life of AD patients using a compensatory M1 (a muscarinic receptor agonist) with ligand/receptor mechanisms to improve brain network connectivity. AZTherapies's drugs are based on technologies developed at Massachusetts General Hospital, a Harvard Medical School Teaching Hospital.