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– 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 billion1 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 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 million2.
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
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 – for UK enquiries Tel: +44 (0) 20 3709 5700
Chris Gardner / Mary-Jane Elliott
Ivar Milligan / Philippa Gardner
MC Services – for Continental European enquiries Tel: +49 211 5292 5222
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.