A new class of peptide-based coagulant for surgical bleeding.
Ergomed is developing a new class of coagulant, or “haemostat”, for treating bleeding during surgical operations. Sales of current haemostats exceed $2.5 billion pa, and the market is driven by a steady increase in surgical interventions. Current product limitations include slow onset of action, lack of efficacy, and the need to prepare formulations prior to use. The market leader, the enzyme thrombin, is also typically extracted from human or bovine blood exposing patients to the potential risk of blood-borne infective agents. Ergomed’s products are based on a peptide that binds to fibrinogen in the blood, converting it to a fibrin-like clot. This novel mode of action is very rapid and effective. Moreover the peptide-based products are blood-free and available in ready-to-use liquid and gel formulations. Thrombin by contrast is only stable in dry or frozen forms, and is typically reconstituted or thawed prior to use. Ergomed’s products are protected by 9 patent families. Please note that the products below are not approved for sale, and require further clinical studies to validate claims.
Rapid control of bleeding with active peptide technology
PeproStat™ is a ready-to-use liquid formulation applied with commercially available gelatin sponges. Animal trials have demonstrated that PeproStat had the fastest onset of action versus three thrombin-based comparators. PeproStat has also been tested in 20 liver surgery patients at four hospitals in the UK. Whilst this trial was not comparative, the results support comprehensive animal data indicating fast and effective action. A comparative Phase II trial in three surgical indications has commenced at 30 sites across Europe, and is expected to report in Q1 2018. The trial involves 120 patients and will test efficacy and safety
Control remote bleeding with active peptide technology
ReadyFlow™ is a ready-to-use flowable gel formulation applied with a syringe and nozzle to less accessible and/or uneven wound surfaces. Current products are limited by the need for preparation prior to use and since bleeding is not always predictable, product may be wasted or insufficient prepared. Current products are also blood-derived. ReadyFlow is a single ready-to-use syringe suitable for both surgical and emergency use, and is made from blood-free components. The product has been tested in a robust pre-clinical bleeding model, in which 85% of bleeds were controlled with just one minute of compression
Molecule and Mode of Action
The PeproStat active is based on coupling multiple fibrinogen-binding peptides to a soluble carrier, thus forming a highly active fibrinogen-binding site (Figure A). The active peptide is a short 5mer sequence (Gly, Pro, Arg, Pro, Gly) that binds to the distal ends of the bi-polar fibrinogen molecule, forming a fibrinogen: PeproStat co-polymer (Figure B). The co-polymer then assembles into branched fibrils, to form a robust clot (Figure C). This new mode of action, based on peptide : protein recognition, is very rapid and effective, and has been demonstrated in numerous pre-clinical surgical haemostasis models, and a clinical trial in liver surgery.
The active substance in ReadyFlow, HXP12, is a derivative of PeproStat that is purely peptide-based and fully synthetic. HXP12 has several benefits including greater thermal stability and ultra-low cost of goods.
HXP12 peptide derivative is a highly potent fully synthetic coagulant and is the active substance in ReadyFlow. HXP12 binds to the “a” or “b” sockets in fibrinogen.
Platform Technology & Research Pipeline
Ergomed has a research program aimed at conjugating the active peptide to a range of materials or combining the active with fibrinogen to develop products in the surgical and regenerative medicine space. If you are interested in developing a product using the platform technology please contact Ben.Nichols@ergomedplc.com