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Headline data expected in Q1 2018
British company’s invention for surgical bleeding advances in clinical development
London, UK – 20 March 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, is pleased to announce the initiation of a phase IIb proof-of-concept study for Peprostat, a highly innovative treatment for intraoperative surgical bleeding. Having gained UK Medicines and Healthcare Products Regulatory Agency (MHRA) approval to start the study, the UK participating centres are now starting to recruit patients.
PeproStat is a potentially disruptive product which could enter the $2.5 billion market for surgical haemostats. Current products may be limited by a range of issues, including slow onset of action, lack of effect on stronger bleeds and long preparation time. PeproStat is based on a synthetic peptide and therefore 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 we expect the product to gain significant market share.
120 patients will be enrolled in a randomised, placebo controlled, double blind, Phase II study in up to 30 centres across seven European countries. The primary objective of the study is to evaluate the efficacy of PeproStat to control bleeding during surgery. The study will examine four different surgical procedures, liver, soft tissue, vascular and spinal. The trial is expected to report top line data in Q1 2018. This follows on from a 20 patient UK Phase I study conducted in liver surgery patients that indicated that the product was safe, fast and effective.
Peprostat is the lead product in development based on the discovery, with ReadyFlow in mid stage pre-clinical development. 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 initiation of this Phase IIb trial is another important milestone for Ergomed following the acquisition of Haemostatix. We believe that PeproStat can overcome the disadvantges associated with the use of current products for intraoperative surgical haemostasis. We believe that we have a good chance of obtaining successful results, and with that a compelling data package to advance the product into late stage development and commercial collaboration.”
Dr Paul Hayes, Addenbrookes Hospital, Cambridge, said:
“Excess bleeding during surgery lengthens operation times, can increase complications and may result in returns to theatre. None of our current haemostats are ideal, and so novel therapies such as this are always welcome. I look forward to recruiting patients into this exciting trial.”
|Ergomed plc||Tel: +44 (0) 1483 503205|
|Miroslav Reljanovic (Chief Executive Officer)|
|Andrew Mackie(Chief Business Officer)|
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|Michael Meade / Freddie Barnfield (Nominated Adviser)|
|James Black (Joint Broker)|
|Stifel Nicolaus Europe Limited||Tel: +44 (0) 20 7710 7600|
|Jonathan Senior / Ben Maddison (Joint Broker)|
|FTI Consulting – for UK enquiries||Tel: +44 (0) 20 3727 1000|
|Simon Conway / Mo Noonan|
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Ergomed plc is a profitable UK-based business providing drug development services to the pharmaceutical industry and has a growing portfolio of co-development partnerships. It operates in over 50 countries.
Ergomed provides clinical development, trial management and pharmacovigilance services to over 100 clients ranging from top 10 pharmaceutical companies to small and mid-sized drug development companies. Ergomed successfully manages clinical development from Phase I through to late phase programmes.
Ergomed has a wide therapeutic focus, with a particular expertise in oncology, neurology and immunology and the development of orphan drugs. Ergomed believes its approach to clinical trials is differentiated from that of other providers by its innovative Study Site Management model and the use of Study Physician Teams, resulting in a close relationship between Ergomed and the physicians involved in clinical trials.
As well as providing high quality clinical development services, Ergomed is building a portfolio of co-development partnerships with pharma and biotech companies which share the risks and rewards of drug development. Ergomed leverages its expertise and services in return for carried interest in the drugs under development. Lastly, Ergomed recently acquired a pipeline of proprietary development products for haemostasis in surgical settings. For further information, visit: https://ergomedplc.com.