Ergomed plc Recruitment complete early for Phase IIb study
July 24 2017 - 1:01AM
RNS Non-Regulatory
TIDMERGO
Ergomed plc
24 July 2017
PRESS RELEASE
FOR IMMEDIATE RELEASE
Ergomed completes Phase IIb study recruitment six months ahead
of schedule for its innovative coagulant PeproStat
- Top line results expected in Q4 2017, six months earlier than anticipated
- Faster than expected recruitment reflects Ergomed's strong CRO capabilities
London, UK - 24 July 2017: Ergomed plc (LSE: ERGO) ('Ergomed' or
the 'Company'), a specialised pharmaceutical services and drug
development company, today announces that recruitment has been
completed ahead of schedule in its Phase IIb proof-of-concept study
for PeproStat, Ergomed's highly innovative new coagulant, or
'haemostat', for intraoperative surgical bleeding. As previously
communicated, with recruitment completed ahead of schedule, the
trial is expected to report top line data in Q4 2017.
Dr Dan Weng, Chief Executive Officer of Ergomed, said: "We are
delighted to have completed recruitment of the PeproStat Phase IIb
trial about six months ahead of schedule. This demonstrates not
only strong physician interest in this innovative haemostat, but
also Ergomed's ability as a specialist drug developer to
efficiently recruit patients fit for study purpose. We look forward
to seeing data later this year."
PeproStat is a potentially disruptive product which could enter
a global haemostat market estimated to be worth $2.8 billion(1) in
2020. 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.
More than 160 patients have now been enrolled in the randomised,
placebo controlled, double blinded Phase IIb study in up to 16
centres across five 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(2)
.
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 completion of recruitment into
the trial and we eagerly anticipate the data and further
development of this potential alternative."
Dr Miroslav Reljanovic, Executive Vice-Chairman of Ergomed,
added: "We are excited to see that the lead product from our
Haemostatix acquisition is developing rapidly towards late stage
development and commercial collaborations. This, combined with the
interest we have received for PeproStat from industry, underpins
our strategy to generate value by developing new medicines as
internal assets as well as shared-risk collaborations."
(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.
(2) Company estimate
ENDS
Enquiries:
Ergomed plc Tel: +44 (0)
1483 503205
Dan Weng (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 provides specialist services to the pharmaceutical
industry and develops drugs both wholly-owned and through
partnerships. Ergomed's fast-growing, profitable service offering
spans all phases of clinical development and post-approval
pharmacovigilance and medical information. Drawing on more than 20
years of expertise in drug development, Ergomed is also building a
growing portfolio of drug development partnerships and programmes,
including wholly-owned proprietary 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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