Last Patient Finishes ALZT-OP1 Combo Therapy Trial; Results Expected Early 2021

Last Patient Finishes ALZT-OP1 Combo Therapy Trial; Results Expected Early 2021
The last participant has completed all predefined assessments in the Phase 3 COGNITE clinical trial, which is assessing the safety and effectiveness of AZTherapies’ treatment candidate ALZT-OP1 for people with early Alzheimer’s disease. The trial’s top-line results are expected in the first months of 2021. The biopharmaceutical company hopes its investigational therapy will be found to slow or even stop the progression of Alzheimer's. “We will soon begin data analysis, bringing us one step closer to validating our hypothesis that targeting neuroinflammation could be the key to modifying disease progression — stopping or slowing the advance of early stage Alzheimer’s disease,” David R. Elmaleh, PhD, AZTherapies’ scientific founder, executive chairman, and chief scientific officer, said in a press release. “Notably, the COGNITE trial also includes a landmark cerebrospinal fluid [CSF] biomarker component that should allow for future exploration of correlations between biomarkers and clinical response,” Elmaleh added. Of note, the CSF is the fluid that surrounds the brain and spinal cord. ALZT-OP1 is a proprietary combination of two previously approved small molecules that have been re-engineered and optimized to reach the brain and provide a daily dose that could potentially suppress the neuroinflammation that leads to neuronal death in Alzheimer’s patients. Designed to be a convenient and easy-to-use inhaled and oral delivery kit for once-daily home use, ALZT-OP1 consists of a dry-powder inhaler containing cromolyn (designated ALZT-OP1a) and oral pills containing ibuprofen (designated ALZT-OP1b). Preclinical studies have shown that cromolyn, used to treat asthma, can halt the formation of toxic amyloid-beta clumps — one of Alz
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