Ergomed plc PeproStat study passes recruitment mid-point
21 June 2017 - 4:00PM
RNS Non-Regulatory
TIDMERGO
Ergomed plc
21 June 2017
PRESS RELEASE
FOR IMMEDIATE RELEASE
PeproStat Phase IIb study passes recruitment mid-point ahead of
schedule
- Top line results brought forward to Q4 2017
London, UK - 21 June 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 that its Phase IIb proof-of-concept study
for PeproStat, Ergomed's highly innovative new coagulant, or
'haemostat', for intraoperative surgical bleeding, has reached its
recruitment mid-point ahead of schedule. The trial is now expected
to report top line data in Q4 2017, accelerated from Q1 2018.
PeproStat is a potentially disruptive product which could enter
a global haemostat market estimated to be worth $2.8 billion in
2020(1) . Current products may be limited by a range of issues,
including slow onset of action and long preparation time.
PeproStat, based on a synthetic peptide which eliminates the risk
of exposure to blood derived materials, is more stable allowing the
formulation of ready-to-use preparations and has a fast mode of
action. With these advantages Ergomed expects the product will gain
significant market share.
Over half of the 140 patients have now been enrolled in a
randomised, placebo controlled, double blinded Phase IIb study in
up to 30 centres across seven European countries. The primary
objective of the study is to evaluate the efficacy of PeproStat in
controlling bleeding during surgery. The study is examining four
different surgical procedures: liver; soft tissue; vascular; and
spinal. This follows on from a 20 patient UK Phase I study
conducted in liver surgery patients that indicated the product was
safe, fast and effective.
PeproStat is the lead product in Ergomed's haemostatix
portfolio, with ReadyFlow(TM) in mid-stage pre-clinical
development. Ergomed believes that together these two products are
estimated to have peak sales potential of more than $500
million.
Dr. Miroslav Reljanovic, Chief Executive Officer of Ergomed,
said:
"The accelerated recruitment of this Phase IIb trial
demonstrates not only strong physician interest in this innovative
haemostat but also Ergomed's ability as a specialist drug developer
to efficiently recruit patients and conduct studies faster than
industry standards. We look forward to the results which are now
expected in Q4 2017 and, if successful, to establishing a
compelling data package to advance the product into late-stage
development and commercial collaboration."
Dr. Paul Hayes, Addenbrookes Hospital, Cambridge, UK, the Chief
Investigator for the trial, said; "Access to novel haemostats such
as PeproStat could provide better control of excess bleeding during
surgery than current products. This could help reduce operation
times, complications and prevent unnecessary returns to surgery. It
has been very satisfying to see the speed of recruitment into the
trial and the acceleration in the development of this potential
alternative."
(1) Hemostats Market by Product Type (Thrombin, Oxidised
Regenerated Cellulose, Combination, Gelatin, Collagen), and
Geography (Americas, Europe, APAC, MEA) - Global Forecast to 2020.
MarketsandMarkets, February 2016.
ENDS
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)
N+1 Singer Tel: +44 (0)
20 7496 3000
Alex Price (Joint Broker)
Consilium Strategic Communications Tel: +44 (0)
- for UK enquiries 20 3709 5700
Chris Gardner / Mary-Jane ergomed@consilium-comms.com
Elliott
Ivar Milligan / Philippa Gardner
MC-Services - for Continental Tel: +49 211
European enquiries 5292 5222
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 acquired a pipeline of proprietary development products for
the treatment of surgical bleeding. 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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