Protein coated gauze dressing – pre commercial trial & commercialisation

Summary

IRL (Industrial Research Limited) in New Zealand and MLA identified a bioactive from bovine / ovine eye lenses that significantly improve wound healing. In this project the technology was advanced to the stage of ‘commercial-ready’ through; animal trials to validate the laboratory tests; critical analysis of key commercial drivers and impediments; identifying and targeting commercial partners with the capacity to commercialise the technology.
Currently, bovine and ovine eye lenses are considered to have little value and are largely sent rendering where they are worth less than 5¢ per head. Extraction of a bioactive from eye lenses for use in high value wound healing applications could significantly boost demand for lenses and preliminary calculations indicated that the value of lenses could be increased 10-fold to in excess of 50¢ per head.
From an extensive screening of the extracellular matrix from low-value animal co-products, six extracts were isolated with interesting biological activity. The lead extract, isolated from ovine and bovine eyes, was shown to stimulate angiogenesis and promote cell migration of endothelial cells and thus had the potential to stimulate wound healing. A clinically and commercially suitable method for the isolation and preparation of a wound dressing using this protein extracted from lenses was developed. Several formulations were tested and complications associated with formulation of the intact protein complex overcome by targeting the isolation and purification of the active ingredient which was subsequently identified as a small (573 Dalton) peptide (GAP573). Methods for the rapid purification of the peptide from eye lenses and its formulation into wound dressings were developed.
A combination device (termed AL573) based on an alginate gel incorporating GAP573 was tested an ethically approved pre-clinical animal study. AL573 demonstrated significantly faster wound-healing than Fibracol-Plus, a market leading wound-healing product. The mechanism by which GAP573 mediated its action was identified as down-regulation of gap junction communication, promoting cell migration and blood vessel formulation. Treatment with the GAP573 was also found to reduce inflammation and scarring.
In an analysis of manufacturing costs, de-novo synthesis of GAP573, using modern peptide synthetic methods, was found to be significantly less expensive, than extraction from bovine or ovine eye lens. In addition, the regulatory (e.g. FDA or TGA- approval) and commercial  (e.g. establishment of a suitable supply chain) barriers were found to be lower as suitable GMP-approved peptide manufacturing facilities exist which are capable of scalable manufacture that meets regulatory requirements. Thus, using GMP-peptide synthesis for manufacture provides the best opportunity for the commercialisation of this technology. With no requirements for (co)products from the red meat industry MLA’s focus was on licensing the technology.
For the wound-healing application (AL573) of the technology an analysis of the regulatory hurdles indicated that this product would be classified as a ‘combination device’ comprised of an existing device (alginate gel) and a therapeutic (GAP573). In Europe this would be a class 3 medical device and in US would be considered a ‘biologic’ and directed towards the FDA Office of Combination Products. For reimbursement in the US and Europe, a new code would be required as existing codes do not cover the mode of action for this device.
The market for advanced wound healing products is large and growing especially for the treatment of chronic ulcers. There is a particular need for combination products that combine existing materials with biologic molecules to accelerate healing and reduce scar formation. The IRL/MLA peptide in an alginate gel is a novel solution to this unmet market need. Given there are a number of large companies in the current wound healing space, a partnership for the next stage of commercialisation is being investigated but as of 2016, had not progressed further,