Memogain® is a patented pro-drug of an existing Alzheimer’s drug, galantamine (Reminyl®), 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.
Initial discussions with the European Medicines Agency’s (EMA) Innovative Task Force indicate that Memogain appears to satisfy the criteria for ‘Innovative Medicine’ status that could lead to accelerated marketing authorization. Scientific Advice received from the EMAs Committee for Medicinal Products for Human Use (CHMP) indicates that a single appropriately powered six month cognition trial may well be sufficient to support an application for marketing authorization (should the remaining Phase I data continue to indicate improved safety and tolerability). Marketing Authorization could be granted on completion of Neurodyn’s clinical development program in as little as 24-36 months. Additionally, Memogain may qualify for US FDA ‘Breakthrough Therapy’ designation and a 505(b)(2) expedited pathway to market approval.
Due to Memogain’s expected improved safety and efficacy, reduced side effects, and potential disease modifying effect, it is expected that the revenue potential for Memogain could outmatch the sales of the present market-leading drug.