CATALANO, SUSAN M
COGNITION THERAPEUTICS, INC.
Phase 1b first-in-patient safety trial for CT1812, a novel Alzheimers synaptic protection therapeutic
Alzheimer's disease & other dementias
Acquired Cognitive Impairment... Aging... Alzheimer's Disease... Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD)... Brain Disorders... Clinical Research... Clinical Research - Extramural... Clinical Trials and Supportive Activities... Dementia... Neurodegenerative... Neurosciences... Patient Safety... Translational Research
Abstract Project Summary Cognition Therapeutics Inc. (CogRx) has discovered CT1812, a novel oligomer receptor antagonist that is the only drug candidate demonstrated to prevent and displace binding of Abeta oligomers to receptors on brain cells. By stopping the initiating event in the Abeta oligomer cascade, this first-inclass drug candidate completely blocks downstream synaptotoxicity and restores memory to normal in aged transgenic mouse models of Alzheimers disease. CT1812 is an orally administered lipophilic isoindoline formulated as a fumarate salt that is rapidly absorbed and highly brain penetrant. It displaces receptor-bound Abeta oligomers by allosterically antagonizing the sigma-2/PGRMC1 receptor (Izzo et al., 2014a, b). CT1812 thus represents the first disease-modifying therapeutic that will test the oligomer hypothesis of Alzheimers disease. Such a drug candidate would significantly impact the lives of the 35 million patients worldwide suffering from AD and MCI, for whom no disease-modifying treatment exists. This application proposes to assess the safety and pharmacokinetics of oral doses of CT1812 in a Phase Ib clinical trial in early Alzheimers patients. Successful completion of this Phase Ib safety trial will lay the groundwork for future studies of CT1812s therapeutic effectiveness in larger Phase 2 trials in Alzheimers patients.
Project Narrative Cognition Therapeutics Inc. has discovered a drug candidate that promises to stop and even reverse the memory loss in Alzheimers disease. This drug candidate, CT1812, works by a completely novel mechanism to stop the binding of toxic proteins that build up in the brains of Alzheimers patients known as Abeta oligomers. We are requesting funding support to conducct clinical trials of this drug candidate in Alzheimers patients in order to measure its safety. Such a drug candidate would significantly impact the lives of the 35 million patients worldwide suffering from Alzheimers disease and Mild Cognitive Impairment, for whom no disease-modifying treatment exists.