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– 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™ 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[I]
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™, 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 billion1. 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 ReadyFlowTM 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[II].
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 email@example.com.
I – 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.
II – Company estimate
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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.