PITTSBURGH, July 19, 2017 — Cognition Therapeutics, Inc., a clinical stage neuroscience company focused on the development of innovative small molecule therapeutics for the treatment of Alzheimer’s disease and other neurocognitive disorders, today presented results of an open-label Phase 1 study of Cognition’s lead clinical candidate, CT1812. In this study, which was presented at the Alzheimer’s Association International Conference in London, no clinically significant drug-drug interactions were identified with CT1812, suggesting that CT1812 can be administered in current and future clinical trials with few medication exclusions.
CT1812 is an orally available small molecule designed to displace the toxic oligomer form of the amyloid beta (Aß) protein and inhibit its binding to the sigma2/PGRMC1 receptor complex. When bound to this receptor complex, Aß oligomers can disrupt synaptic activity, leading to the destruction of neuronal synapses, memory loss and learning deficits.
“The minimal drug-drug interaction profile observed with CT1812, combined with the lack of drug-food interaction and strong safety results previously reported, indicate an acceptable tolerability profile for this experimental Alzheimer’s medicine,” said Susan M. Catalano, PhD, Cognition’s chief science officer. “Given that patients with Alzheimer’s disease are often on multiple drug regimens to manage the symptoms of the disease as well as other conditions associated with their advanced age, this will be an important differentiating factor as we advance CT1812 into larger clinical studies.”
To determine the potential drug-drug interaction associated with CT1812, the Phase 1 COG01013 study enrolled 14 healthy adults who received six consecutive daily oral doses of CT1812 before and following four probe drugs (dextromethorphan, midazolam, omeprazole and tolbutamide) that represent the activity of specific cytochrome P450 (CYP450) enzymes. CYP450 is a family of isozymes that are responsible for the breakdown of many drugs, and influences on them can lead to drug-drug interactions and toxicities. No interactions between CT1812 and omeprazole or tolbutamide were observed in this study, and only weak interactions were measured with midazolam and dextromethorphan, suggesting the potential for clinically insignificant inhibition of CYP2D6 and induction of CYP3A4 enzymes by CT1812.
Overall, the incidence of treatment-related adverse events was low, which was consistent with findings from the Phase 1 studies. Headache, GI symptoms and dizziness were the most commonly reported adverse events.
AAIC Presentation Details:
Title: A Phase 1 Safety Trial of the A? Oligomer Receptor Antagonist CT1812
Authors: Susan Catalano, PhD, Michael Grundman, MD, Michelle Higgin, PhD, Julie Pribyl, Kelsie Mozzoni, Nicholas J Izzo, PhD, and Hank Safferstein, PhD of Cognition Therapeutics; Lon Schneider, MD of the USC Keck School of Medicine; Steven DeKosky, MD of the University of Florida; Roger Morgan, MD of MedSurgPI, LLC; and Robert Guttendorf, PhD of the Aclairo Pharmaceutical Development Group
Time: 9:30am – 4:15pm on Wed, Jul 19, 2017
Location: S8, P4-567
About AAIC
The Alzheimer’s Association International Conference 2017 (AAIC) in London is the largest international meeting dedicated to advancing dementia science. AAIC unites the world’s leading researchers, next generation investigators, clinicians and the care research community to share discoveries in basic and translational research that will lead to methods of prevention and treatment, and improvements in diagnosis for Alzheimer’s disease and other dementias. To learn more, visit www.alz.org/aaic.
About Cognition Therapeutics, Inc.
Cognition Therapeutics (CogRx) is a privately held biopharmaceutical company whose disease-relevant screening and novel chemistry platforms have produced a pipeline of disease modifying small molecule drug candidates which are being developed to treat Alzheimer’s disease and potentially other neurocognitive disorders. Cognition’s lead molecule, CT1812, is a proprietary first-in-class, orally available small molecule. This highly brain penetrant compound targets the sigma-2/PGRMC1 receptor complex, displacing toxic beta amyloid oligomers from their binding sites on brain cells and clearing them into the cerebrospinal fluid. CT1812 has been shown in multiple Alzheimer’s disease models to stop memory loss. In Cognition’s ongoing Study COG0102, patients with mild-to-moderate Alzheimer’s disease are being randomized to one of three doses of CT1812 or placebo, and dosed for 28 days to help evaluate the safety, tolerability and pharmacokinetic profile of CT1812. Additional information about Cognition may be found online at www.cogrx.com.