A Phase IIa clinical study will test the efficacy, safety and tolerability profile
Ferrer, a privately-held Spanish pharmaceutical company, today announces that it has executed two agreements; with Ildong Pharmaceuticals Co Ltd, Korea and Ergomed Clinical Research Ltd, UK to support further clinical studies of Lorediplon in patients with insomnia.
Under the terms of the Ildong agreement, Ferrer will be eligible to receive payments from the Co-operation and License Agreement covering countries within East Asia, including South Korea, China and Japan. Ildong will be responsible for the costs and activities related to development and regulatory approvals in their territory.
Ferrer selected Ergomed as the clinical development organization to conduct the multicenter, multinational, randomized Phase IIa Lorediplon trial in insomnia. Under the terms of the agreement, Ergomed will assume a proportion of the clinical and regulatory costs of the Phase IIa trial in return for a share of future revenues received by Ferrer for Lorediplon in this indication.
“We are delighted to announce this collaboration with Ferrer,” said Ildong chairman and CEO, Jung-chi Lee, Ph.D. “We are ready to fully cooperate in order to improve quality of life for patients.”
“We are very pleased to co-invest with Ferrer in the development of Lorediplon, which has shown promising results in clinical trials to date,” said Miroslav Reljanovic, M.D., CEO of Ergomed. “Our seventh co-development agreement establishes us as one of the leading worldwide companies completing deals under this innovative model.”
“We look forward to working with our partners Ergomed and Ildong on the development of Lorediplon as a treatment for patients with underserved needs in insomnia and continue to seek additional partners to further the clinical development and commercialisation of Lorediplon in other territories’” said Ferrer COO, Antoni Villaro Martin.
“Insomnia remains a common sleep disorder that has both 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.”
About the Phase IIa study
The trial is a double-blind, randomized, placebo-controlled cross-over, dose finding study of two doses of Lorediplon in adult patients with primary insomnia. 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 characterize the efficacy in sleep maintenance and sleep onset and to evaluate any next day hangover effect in adult patients with primary insomnia. The trial is anticipated to be initiated in the second quarter of 2014. It will involve approximately 130 patients at 12 centres in three countries (further details will be made available at http://www.clinicaltrials.gov).
Lorediplon is a novel, longer acting non-BZD hypnotic drug that modulates the GABAa receptor. Compared to other non-BZD receptor agonists (such as zolpidem), Lorediplon has demonstrated in preclinical and clinical studies 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 I 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. 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 is the subject of a number of granted and pending patents and is available for further worldwide development and commercialisation from Ferrer.
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, while 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 healthcare utilization and 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 associated with changes in sleep architecture, decrease in psychomotor and cognitive functioning, dependency, withdrawal effects, increased incidence of falls and apnea.
Founded in 1959, Ferrer is a privately-held Spanish pharmaceutical company. It is present in more than 90 countries, with 23 international affiliates. Ferrer is active in the pharmaceutical, health, fine chemicals and food sectors; key areas for contributing to people’s health and quality of life. The main therapeutic areas covered by Ferrer’s pharmaceutical production are dermatology, cardiovascular, CNS, cancer, gastrointestinal, analgesics, bone metabolism, anti-infectives, immunology, diagnostics, OTC and dermocosmetics. For more information, visit: http://www.ferrergrupo.com
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. Ildong, founded in 1941, is known to have leading expertise in various therapeutic categories, including neurology, antibiotics, gastrointestinal, anti-diabetics, cardiovascular and oncology. For more information, visit: http://www.ildong.com
Ergomed is a clinical development company working with biotechnology and pharmaceutical companies specializing in therapeutics for oncology, neurology and immunology. Ergomed also engages in shared risk ventures through co-development agreements. With its global infrastructure in Western and Eastern Europe, the Middle East and North America, Ergomed offers cost effective and efficient drug development. For further information, visit: http://www.ergomed-cro.com