Ferrer, a privately-held Spanish pharmaceutical company, announced 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.
Ferrer is conducting the phase IIa study in collaboration with its partners Ergomed plc, UK and Ildong Pharmaceuticals Co Ltd, Korea. 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.
“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, chief scientific officer at Ferrer. “Lorediplon is the first product to enter clinical trials from our CNS discovery programme, the aim of which is to deliver differentiated products targeting underserved needs in insomnia and related sleep disorders.”
Lorediplon is a novel, longer acting non-BZD (benzodiazepine) hypnotic drug that modulates the GABAa receptor. Compared to other non-BZD receptor agonists (such as zolpidem) in preclinical and clinical studies, Lorediplon has demonstrated a potent hypnotic profile and extended systemic half-life; properties that could confer potential clinical benefits in terms of sleep maintenance and sleep architecture. A recent phase 1 pharmacodynamic study with Lorediplon (in a phase advanced model of insomnia) demonstrated the orally available compound has a best-in-class efficacy profile in terms of sleep maintenance and sleep quality when compared to market leader zolpidem. Lorediplon was safe and well tolerated, with no residual effects observed up to fourteen hours after dosing.
Insomnia is a common sleep disorder characterized by difficulty in the initiation and/or maintenance of sleep, or abnormalities in the duration or restorative quality of sleep. While the prevalence of insomnia varies, it has been estimated that transient insomnia lasting less than two weeks affects up to 80 per cent of the population on a yearly basis; whilst chronic insomnia affects 15 per cent of the population. Sleep maintenance insomnia, or the inability to stay asleep throughout the night, is significantly more prevalent than sleep onset insomnia.
Insomnia is often accompanied or caused by other comorbid conditions and is associated with significant night-time and daytime symptoms, including tiredness, difficulty concentrating and irritability as well as increased use of healthcare, reduced work productivity, lower quality of life and impairments of memory, mood and cognitive function.
Currently, the major hypnotic drugs on the market are gamma-Amino Butyric Acid A (GABAa) receptor modulators. They potentiate GABA, the main inhibitory neurotransmitter in the brain, facilitate sleep onset and sometimes total sleep time but their use is also associated with changes in sleep architecture, decrease in psychomotor and cognitive functioning, dependency, withdrawal effects, increased incidence of falls and apnea.
Ildong Pharmaceutical Co., Ltd., based in Seoul, Korea, is a leading Korean company focused on the development, manufacturing and marketing of pharmaceuticals and OTC products.
Ergomed Plc is a profitable UK-based company providing drug development services to the pharmaceutical industry and has a growing portfolio of co-development partnerships.