Lorediplon previously demonstrated - in a phase advanced model of insomnia - a potential best-in-class efficacy profile in terms of sleep maintenance and sleep quality when compared to market leader zolpidem
Ferrer, a privately-held Spanish pharmaceutical company, today announces the first patient has been recruited into a phase IIa clinical trial to test the efficacy, safety and tolerability profile of Lorediplon in adult patients with insomnia disorder. The study is scheduled to be completed by Q4, 2016.
The trial is a double-blind, randomized, placebo-controlled cross-over, dose finding study of two oral doses of Lorediplon in adult patients with insomnia disorder. The effects of Lorediplon (5 and 10 mg) will be compared to a placebo and to zolpidem. The aim of the study is to evaluate the appropriate effective dose of Lorediplon, to further characterize the efficacy in sleep maintenance and sleep onset and to evaluate any next day hangover effect in adult patients with insomnia disorder. It will involve approximately 130 patients at 13 centres in Germany, Poland and Croatia (further details will be made available at http://www.clinicaltrials.gov).
Ferrer is conducting the phase IIa study in collaboration with its partners Ergomed plc, UK and Ildong Pharmaceuticals Co Ltd, Korea (http://www.ala.com/article.php?id=339). Lorediplon is the subject of a number of granted and pending patents and is available from Ferrer for further worldwide development and commercialisation.
In 2012, Ferrer successfully completed a clinical trial with Lorediplon that demonstrated dose related clinical benefits in measured sleep parameters that were either comparable to or exceeded zolpidem in terms of the maintenance and quality of sleep that subjects achieved, ref: Hum. Psychopharmacol Clin Exp 2014; 29: 266–273.
“Insomnia remains a common sleep disorder that has a significant impact on an individual’s quality of life and a broader impact on society, in terms of reduced productivity and associated healthcare costs,” said Fernando Garcia Alonso, CSO at Ferrer. “Lorediplon is the first product to enter clinical trials from our CNS discovery program, the aim of which is to deliver differentiated products targeting underserved needs in insomnia and related sleep disorders.”