Recruitment completed in phase IIa clinical trial

RNS Number : 2253J

Ergomed plc

08 September 2016

 

PRESS RELEASE

FOR IMMEDIATE RELEASE

Ergomed completes recruitment of Phase IIa clinical trial of lorediplon in insomnia in collaboration with co-development partner Ferrer

Results expected at the end of the year

London, UK - 8 September 2016: Ergomed plc (LSE: ERGO) ('Ergomed' or 'the Company'), a profitable UK-based group dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs, announces that it has completed recruitment in a Phase IIa clinical trial of lorediplon in patients with insomnia disorder.

Under Ergomed's co-development agreement with Ferrer, the Phase IIa clinical 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) are being compared to both placebo and zolpidem.  The aim of the study is to evaluate the appropriate effective dose of lorediplon, to further characterise its efficacy on sleep maintenance/sleep quality and to evaluate any next day hangover effects in adult patients with insomnia disorder. 

The recruitment target of at least 130 patients has been met from 11 clinical sites across three European countries.  The clinical trial is expected to complete in Q4 2016 with the final results announced around the end of the year.

Dr. Miroslav Reljanovic, Chief Executive Officer of Ergomed, said: 

"The completion of patient recruitment in the Phase IIa study in insomnia marks another important step in the clinical development of lorediplon for the treatment of 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 the market leader zolpidem. This would make a marked improvement in the lives of patients suffering from this disorder.  We look forward to reporting the results around the end of the year."

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Enquiries:

Ergomed plc	Tel: [phone]
Miroslav Reljanovic (Chief Executive Officer)
Stephen Stamp (Chief Financial Officer)
Numis Securities Limited	Tel: [phone]
Michael Meade / Freddie Barnfield (Nominated Adviser)
James Black (Joint Broker)
Stifel Nicolaus Europe Limited	Tel: [phone]
Jonathan Senior (Joint Broker)
FTI Consulting - for UK enquiries	Tel: [phone]
Simon Conway / Mo Noonan
MC Services AG - for Continental European enquiries	Tel: [phone]
Anne Hennecke

About Ergomed

Ergomed plc is a profitable UK-based business providing drug development services to the pharmaceutical industry and has a growing portfolio of co-development partnerships. It operates in over 50 countries.

Ergomed provides clinical development, trial management and pharmacovigilance services to over 100 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. Lastly, Ergomed recently acquired a pipeline of proprietary development products for haemostasis in surgical settings. For further information, visit: http://ergomedplc.com.

About Ferrer

Founded in 1959, Ferrer is a privately-held Spanish pharmaceutical company. It is present in more than 95 countries, with 24 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. www.ferrer.com

 

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