Ferrer, a privately-held Spanish pharmaceutical company, has released results from a phase I trial of Lorediplon in insomnia showing it has a best-in-class efficacy profile in terms of sleep maintenance and sleep quality when compared to market leader zolpidem.
The pharmacodynamic effects of a single oral administration of Lorediplon (at 1mg, 5mg and 10mg doses), zolpidem (10mg) and placebo, were assessed in 34 healthy adult subjects employing a phase advanced model of insomnia, in which subjects retire to bed five hours earlier than normal and are required to stay there until early morning. In this model Lorediplon demonstrated dose-related clinical benefits in measured sleep parameters that were either comparable to or exceeded zolpidem, in terms of the duration and quality of sleep that subjects achieved. Lorediplon was safe and well tolerated, with no residual effects observed up to 14 hours after dosing.
In addition, Lorediplon has proven safe and well tolerated in the 129 subjects involved in all phase I clinical studies.
"Insomnia remains a common sleep disorder that has both a significant impact on an individual's quality of life and broader impact on society, in terms of reduced productivity and associated healthcare costs," said Antonio Guglietta, R&D director 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. Having demonstrated the clinical benefits, safety and tolerability of Lorediplon, we are actively seeking partners to further the worldwide clinical development and commercialization of Lorediplon."
The emerging clinical and pre-clinical profile of orally available Lorediplon supports further development as a potential best-in-class non-benzodiazapine (BZD) treatment for sleep insomnia, both in terms of efficacy, tolerability and the absence of next-day residual effects associated with other treatments in this class.