(March 28, 2016) Neurodyn Cognition Inc. has announced that it will be presenting the company’s latest Memogain® clinical trial development results at the upcoming Neurotech Investing and Partnering Conference, in Boston, MA at 10:30am EST on Wednesday April 6, 2016. Mr. Ken Cawkell, Neurodyn Cognition CEO, will be presenting these results as part of a panel session entitled “Treatments for Alzheimer’s and Cognitive Disorders.” Mr. Cawkell’s talk is entitled, “The Brainchild of Neurodyn Cognition: Memogain’s Clinical Trial Results Overview.”
Memogain® is a patented pro-drug of an existing Alzheimer’s drug, galantamine (Reminyl®, Razadyne®), with 10-15x greater brain bioavailability. The drug has a unique and safe mechanism of sensitization of neuronal nicotinic acetylcholine receptors, most notably the alpha-7 subtype, with strong pre-clinical evidence of disease modification. Memogain has successfully completed an enhanced phase I clinical trial, which demonstrated excellent safety and tolerability even at elevated doses, and additionally indicated improved working memory in both young and elderly healthy subjects. The enhanced tolerability is likely to improve patients’ compliance at all stages of treatment – current estimates of drop–out rates range from 30-50% due to lack of perceived benefit and GI side effects.
“Recent regulatory meetings in the EU suggest that Memogain® could be the next Alzheimer’s drug approved in Europe,” says Ken Cawkell, CEO of Neurodyn Cognition. “EU regulators have commented that Memogain® could qualify for market approval based on a single six-month Phase 2 trial for cognition enhancement. For this reason, Memogain has the potential to be in the EU market in 2 to 3 years – faster than anything now in the pipeline.”
Discussions with the European Medicines Agency’s (EMA) Innovative Task Force indicate that Memogain may satisfy the criteria for ‘Innovative Medicine’ status that could lead to accelerated marketing authorization. Advice from the EMAs Committee for Medicinal Products for Human Use (CHMP) indicates that a single six month cognition trial may be sufficient for marketing authorization, which could be granted in as little as 24-36 months. Memogain also appears to qualify for 505(b)(2), Breakthrough Therapy and Accelerated Approval status, which provides a shortened route to market for the USA.
Memogain has a unique mechanism of action by enhancing the responsiveness of nicotinic receptors without desensitization. Nicotinic receptors are recognised as important drug targets for improving cognition and behavior and enhancing neuronal survival. Memogain also has the potential to slow or inhibit disease progression. Both reduced plaque formation and neurogenesis, evidence of disease modification, are well documented in pre-clinical trials.
An enhanced Phase IA clinical trial addressed safety, tolerability, and pharmacokinetics of intranasal Memogain in healthy young and elderly subjects, in comparison to the daily recommended doses of the reference drugs Reminyl and Aricept. Administration of Memogain was safe and well tolerated at all dose levels investigated. The healthy young and elderly subjects in the study were also tested for drug-dependent improvements in cognition. The cognitive test battery demonstrated effects of Memogain on the adaptive tracking test (measuring eye-hand coordination, vigilance and arousal), and in the visual verbal learning test (VVLT, measuring word learning and recall), suggestive of improved short-term memory capacity.
About Neurodyn Cognition Inc.
Neurodyn Cognition Inc. (www.neurodyncognition.ca) is a spin-out company of Neurodyn Life Sciences Inc. (www.neurodyn.ca) set up for the purposes of taking Memogain rapidly to the marketplace. The company maintains office in Canada and Germany, and is currently conducting clinical trials in Europe.