Ergomed plc Partner Asarina Pharma announces successful data
03 April 2017 - 4:01PM
RNS Non-Regulatory
TIDMERGO
Ergomed plc
03 April 2017
PRESS RELEASE
FOR IMMEDIATE RELEASE
Ergomed notes co-development partner Asarina Pharma
announces
successful topline data for its Phase IIa Clinical Study with
Sepranolone in
Premenstrual Dysphoric Disorder ('PMDD')
London, UK - 3 April 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, notes co-development partner, Asarina Pharma, has today
announced the publication of its phase IIa clinical study with
Sepranolone in PMDD in Psychoneuroendocrinology. This study was
completed prior to the companies entering into a co development
relationship.
Sepranolone is Asarina's lead product candidate and potentially
the first therapy to target the underlying cause of PMDD, a severe
and disabling form of premenstrual syndrome affecting approximately
5% of menstruating women. Recruitment for a phase IIb clinical
study is expected to begin towards the end of 2017.
Under the terms of the co-development partnership with Asarina
Pharma, Ergomed will receive an equity stake in the company.
Dr. Miroslav Reljanovic, Chief Executive Officer of Ergomed,
said:
"We are delighted by Asarina's successful phase IIa clinical
study with Sepranolone for women suffering with PMDD. Sepranolone
has the potential to become a first-in-class therapy, normalising
the work and family life of women affected by this debilitating
disorder. The results of this study encouraged us to enter into a
co-development relationship with Asarina and we look forward to
working together on the next stage of development."
The full text of the announcement from Asarina Pharma is as
follows:
Asarina Pharma`s phase IIa clinical study with Sepranolone in
premenstrual dysphoric disorder meets primary endpoint.
Copenhagen - March 31, 2017. Asarina Pharma, a drug development
company focusing on the development of a novel therapy for severe
premenstrual symptoms, publishes the efficacy and safety data from
the randomized, controlled trial involving a total of 120 women
with PMDD, in Psychoneuroendocrinology.
Premenstrual Dysphoric Disorder (PMDD) is a condition with
severe impact on the daily life of approximately 5 per cent of all
women during their fertile years. The condition is caused by an
altered sensitivity in the brain to an endogenous steroid produced
following ovulation, resulting in monthly recurrent episodes of
depression, anxiety and mood lability. Current treatment options
include anti-depressants and oral contraceptives, which have little
effect and are not well tolerated by patients.
Asarina's lead product candidate, Sepranolone, is the first
potential therapy to target the underlying cause of PMDD. Based on
the efficacy data, that met the standard FDA primary endpoint for
studies in PMDD and strong safety profile from the phase IIa study,
Asarina is now preparing a Phase IIb clinical trial, to be
conducted in the US, Germany, UK, Poland and Sweden with
recruitment starting in the fall of 2017.
Enquiries:
Ergomed plc Tel: +44 (0) 1483
503205
Miroslav Reljanovic (Chief
Executive Officer)
Stephen Stamp (Chief Financial
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 / Ben Maddison
(Joint Broker)
FTI Consulting - for UK enquiries Tel: +44 (0) 20
3727 1000
Simon Conway / Mo Noonan /
Natalie Garland-Collins
MC-Services - for Continental Tel: +49 211 52925222
European enquiries
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.
This information is provided by RNS
The company news service from the London Stock Exchange
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