TIDMERGO
RNS Number : 0503W
Ergomed plc
06 February 2017
PRESS RELEASE
FOR IMMEDIATE RELEASE
Ergomed announces positive Phase II top-line results of
co-development partner Ferrer's Lorediplon for the treatment of
insomnia
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.
Highlights:
-- 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."
- Ends -
Enquiries:
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 Tel: +49 (0) 211 52925222
European enquiries
Anne Hennecke
About Lorediplon
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.
About insomnia
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.
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
This information is provided by RNS
The company news service from the London Stock Exchange
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