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PeproStat Phase IIb study passes recruitment mid-point ahead of schedule – Top line results brought forward to Q4 2017

27 June 2017

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. 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 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.

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.”