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Guildford, UK – 14 July 2015: Ergomed plc, (LSE: ERGO or ‘Ergomed’) a profitable UK-based company, dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs, is pleased to report that the first patient has been recruited into the Phase IIa study it is undertaking with Ferrer under the parties’ co-development agreement. The study is a Phase IIa clinical trial testing the efficacy, safety and tolerability profile of Lorediplon in adult patients with insomnia disorder.
Miroslav Reljanovic, Chief Executive Officer of Ergomed, commented: “Lorediplon has previously demonstrated promising results in preclinical and clinical studies, and we believe it has the potential to treat patients within insomnia and related sleep disorders which remains an underserved market where new treatments are needed. The study is on track and we look forward to first data in 2016.”
The announcement issued by Ferrer follows:
Ferrer initiates phase IIa clinical study of Lorediplon in patients with insomnia 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
Barcelona, Spain, July 14, 2015 – 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.”
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, ref: Hum. Psychopharmacol Clin Exp 2014; 29: 266–273. 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% of the population on a yearly basis; whilst chronic insomnia affects 15% 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
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.
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. http://www.ferrer.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. http://www.ildong.com
For further information, please contact:
Mary Clark, Supriya Mathur and Hollie Vile
Tel: + 44 203 440 5654
Stifel Nicolaus Europe Limited
NOMAD/Broker to the Company
Jonathan Senior, Giles Balleny
Tel: + 44 207 710 7600
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. It operates in over 40 countries.
Ergomed provides clinical development, trial management and pharmacovigilance services to over 60 clients ranging from top 10 pharmaceutical companies to small and mid-sized drug development companies. Ergomed successfully manages clinical development from Phase I through to late phase programmes.
Ergomed has a wide therapeutic focus, with a particular expertise in oncology, neurology and immunology and the development of orphan drugs. Ergomed believes its approach to clinical trials is differentiated from that of other providers by its innovative Study Site Management model and the use of Study Physician Teams, resulting in a close relationship between Ergomed and the physicians involved in clinical trials.
As well as providing high quality clinical development services, Ergomed is building a portfolio of co-development partnerships with pharma and biotech companies which share the risks and rewards of drug development. Ergomed leverages its expertise and services in return for carried interest in the drugs under development. For further information, visit: https://www.ergomedplc.com
Forward Looking Statements
Certain statements contained within the announcement are forward looking statements and are based on current expectations, estimates and projections about the potential returns of Ergomed plc (“Ergomed”) and industry and markets in which Ergomed operates, the Directors’ beliefs and assumptions made by the Directors. Words such as “expects”, “anticipates”, “should”, “intends”, “plans”, “believes”, “seeks”, “estimates”, “projects”, “pipeline” and variations of such words and similar expressions are intended to identify such forward looking statements and expectations. These statements are not guarantees of future performance or the ability to identify and consummate investments and involve certain risks, uncertainties, outcomes of negotiations and due diligence and assumptions that are difficult to predict, qualify or quantify. Therefore, actual outcomes and results may differ materially from what is expressed in such forward looking statements or expectations. Among the factors that could cause actual results to differ materially are: the general economic climate, competition, interest rate levels, loss of key personnel, the result of legal and commercial due diligence, the availability of financing on acceptable terms and changes in the legal or regulatory environment.
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