TIDMERGO
RNS Number : 2686U
Ergomed plc
23 October 2017
PRESS RELEASE
Ergomed's first-in-class haemostat, PeproStat(TM), reports
positive top-line results and meets key endpoints in Phase II
study
- Highly innovative blood free haemostat met the primary
efficacy endpoint of superiority over standard of care in time to
haemostasis with statistical significance across all surgery types
tested
- PeproStat was seen to be safe with no treatment related SAEs reported and no re-bleeding
- PeproStat(TM) demonstrated superiority in time to haemostasis
at each time point during 10-minutes assessment over standard of
care
- PeproStat had a higher response rate, with more investigators
finding the product good to excellent with respect to control of
bleeding compared to standard of care and the "liquid and sponge"
format easy/very easy to use
- Results reinforce potential as a safe, blood-free,
ready-to-use and cost-effective method of controlling bleeding
during surgery
- Phase II results ahead of original schedule; preparation for
Phase III in 2018 and potential entry to $2.5 billion global
market(1)
London, UK - 23 October 2017: Ergomed plc (LSE: ERGO) ('Ergomed'
or the 'Company'), a specialised pharmaceutical services and drug
development company, today announces positive top-line results from
its Phase II clinical trial of PeproStat(TM), the Company's
potential first-in-class coagulant, or 'haemostat', for
intraoperative surgical bleeding. PeproStat is a novel, blood-free,
ready-to-use, cost-effective, product based on a peptide which
binds fibrinogen.
The Phase II clinical trial was carried out at 16 hospitals
across five European countries and treated 169 patients undergoing
three types of surgical procedure: liver/soft tissue; vascular and
spinal. The trial was double blinded and compared PeproStat to
standard of care (gelatin sponge). In the control arm, patient
bleeds were treated by applying pressure with a gelatin sponge
soaked in saline, which represents standard of care in Europe. In
the treatment arm, the sponge was soaked with PeproStat. The safety
profile of the product was good, with no treatment-related serious
adverse events, and no re-bleeding after the observation
period.
PeproStat reduced the time to haemostasis (TTH) by 1.55 minutes
(p <0.0041) across all surgery types, demonstrating superiority
compared to the standard of care, the primary efficacy endpoint of
the trial, a statistically and clinically significant result and
one which compares favourably with literature on comparative
products. Notably, in 58.2% of patients the TTH was equal or less
than 2 minutes (standard of care: 32.7%).
The absolute TTH of both PeproStat and standard of care were
higher (4.2 minutes and 5.8 minutes respectively) than seen in the
Phase I trial which may be due to the observation that there was a
greater proportion of moderate (vs mild) levels of bleeding in this
trial compared with the Phase I trial and seen in trials of
competitor products.
80.9% of investigators in the trial rated the product as good to
excellent, compared to 59.6% for standard of care with respect to
controlling bleeding. In addition to improved efficacy, 93.5% of
investigators rated the liquid plus sponge format as easy to very
easy to use, confirming the product's design as a ready to use
formulation.
Ergomed plans to submit detailed data, once a full analysis is
complete, for presentation at upcoming scientific conferences.
Dr Dan Weng, Chief Executive Officer of Ergomed, said: ""We are
delighted to report positive results from the Phase II study. We
believe PeproStat is a first-in-class product which could enter the
large and growing haemostat market as early as 2020. We have
already completed our first commercial agreement for PeproStat and
our other haemostat, ReadyFlow, with Boryung in September, and will
now explore our options to bring this first-in-class haemostat to
the market as soon as possible. Currently, we have a number of
active licensing and partnering discussions to fund further
development."
Dr Paul Hayes, Addenbrookes Hospital, Cambridge, UK, the Chief
Investigator for the trial, said: "Surgical bleeding is a common
problem that can be associated with significant blood loss,
increasing patient morbidity and mortality. PeproStat works fast
and has shown to reduce the non-responder rate by almost 50%
compared to a current standard of care product. This provides
surgeons with a huge and clinically relevant advantage in providing
better control of excess bleeding during surgery and could be
hugely beneficial to patients, reducing operation times,
complications and preventing unnecessary returns to surgery. I am
both impressed by Ergomed's ability to bring this innovative
product through Phase II so efficiently, and really excited by the
results we have seen, demonstrating the potential of PeproStat as
an important new alternative."
The global haemostat market is estimated to be worth $2.5
billion(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.
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)
.
The Phase II study completed six months ahead of the original
schedule, demonstrating both strong physician interest in this
innovative haemostat, and Ergomed's ability as a specialist drug
developer to efficiently recruit patients fit for study
purpose.
Ergomed will hold a conference call for analysts at 08:30 BST.
Dial-in details are: +44 (0) 1452 555 566. Conference ID: 9677908#.
For a copy of the presentation, please email
ergomed@consilium-comms.com.
(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-
Elliott comms.com
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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