London, UK – 6 Febuary 2017: Ergomed plc (LSE: ERGO) (‘Ergomed’ or ‘the Company’), a company dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs, today announces positive top-line results from a Phase II clinical trial of Lorediplon in patients with insomnia with its co-development partner Ferrer. […]
London, UK – 6 Febuary 2017: Ergomed plc (LSE: ERGO) (‘Ergomed’ or ‘the Company’), a company dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs, today announces positive top-line results from a Phase II clinical trial of Lorediplon in patients with insomnia with its co-development partner Ferrer.
- Both 5 and 10mg Lorediplon met the primary endpoint with high statistical significance, indicating the drug has strong efficacy in sleep maintainance throughout the night when compared to placebo
- Lorediplon was well tolerated with an acceptable safety profile including on assessment of next day residual effects
- Lorediplon treatment has preserved natural sleep architecture
- Key secondary endpoints were met including improvements in WASO in the second half of the night relative to zolpidem
- Outcome endorses Ergomed’s hybrid business model
The double-blind, dose-finding 4-way cross-over study was performed in 11 sleep labs in Europe. All 145 patients sequentially received, in a random order, Lorediplon 5 and 10 mg, zolpidem 10mg (typical commercial dose) and placebo to characterise its efficacy, safety and tolerability profile and to evaluate any next day residual effects in adult patients with insomnia disorder.
The study met its primary endpoint, showing a highly statistically significant improvement between Lorediplon and placebo on polysomnography (PSG) derived Wake After Sleep Onset (WASO) throughout the night. Mean WASO decreased by 19 minutes (p<0.0001) on Lorediplon 5 mg and 23 minutes (p<0.0001) on Lorediplon 10 mg compared to placebo. Furthermore, a significant dose-response relationship between WASO and doses of Lorediplon (0 mg (=Placebo), 5 mg and 10 mg) was observed (p<0.0001).
The PSG analysis also showed that Lorediplon preserved natural sleep architecture. Initial analysis shows key secondary endpoints have been met including improvements in WASO relative to zolpidem during the second half of the night. Full results will be presented following detailed further analysis
Both Lorediplon doses were shown to be well tolerated with an overall low incidence of treatment-related adverse events. As expected, for a drug of this class, the most frequently reported treatment related adverse events were dizziness, somnolence, headache, fatigue, hangover and nausea.
Under the terms of the co-development partnership with Ferrer, Ergomed will receive a share of the revenue received from the commercialisation of the drug.
Dr. Miroslav Reljanovic, Chief Executive Officer of Ergomed, said:
“We are delighted by the positive Phase II data for Lorediplon which we believe has the potential to be a significant treatment for insomnia. The study also suggests that Lorediplon may have the potential to improve sleep maintenance for patients over current treatments and leave them feeling refreshed and alert upon awakening.
Importantly, these positive results also endorse Ergomed’s co development business model. As demonstrated here, our experience and expertise of running clinical trials over the last 20 years can be effectively leveraged into progressing commercially attractive assets. We are confident that the sharing of such risk and reward will subsequently translate into significant additional value to our shareholders.”
Fernando Garcia Alonso, Chief Scientific officer at Ferrer said:
“We are very pleased that this study, conducted by Ergomed, has been successful. Lorediplon has proven to be efficacious in maintaining sleep throughout the night and the trends observed relative to zolpidem are very encouraging. Further analysis of the data is ongoing and based on the final results, we will seek to advance the product towards the market through additional partnerships.”
|Ergomed plc||Tel: +44 (0) 1483 503205|
|Miroslav Reljanovic (Chief Executive Officer)|
|Andrew Mackie(Chief Business Officer)|
|Numis Securities Limited||Tel: +44 (0) 20 7260 1000|
|Michael Meade / Freddie Barnfield (Nominated Adviser)|
|James Black (Joint Broker)|
|Stifel Nicolaus Europe Limited||Tel: +44 (0) 20 7710 7600|
|Jonathan Senior (Joint Broker)|
|FTI Consulting – for UK enquiries||Tel: +44 (0) 20 3727 1000|
|Simon Conway / Mo Noonan|
|MC Services AG – for Continental European enquiries||Tel: +49 (0) 211 52925222|
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, such as zolpidem, with WW sales in excess of 500 million dollars in 2015.
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: https://ergomedplc.com.
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