Biotechnology company SolasCure has commenced its Phase II clinical trial, CLEANVLU2, marking the enrolment of the first patient to test the Aurase Wound Gel for chronic wound treatment.
Aurase Wound Gel utilises a hydrogel that dispenses Tarumase, a recombinant enzyme sourced from medical maggots, aimed at debriding fibrin, collagen, and elastin in wounds.
The CLEANVLU2 trial seeks to expand on findings from the earlier Phase IIa study, CLEANVLU, which validated the product’s concept, safety, and painless application.
The new trial will evaluate the effectiveness of higher concentrations of Tarumase in individuals with venous leg ulcers.
Through the trial, SolasCure aims to gather critical efficacy data for Aurase Wound Gel’s application in comprehensive wound bed preparation, including debridement.
The trial is conducted with South Leicestershire Medical Group in the UK as part of its community service initiative.
Following CLEANVLU2’s completion, SolasCure plans another Phase II study to investigate factors affecting debridement and wound healing before moving on to Phase III trials for regulatory submission and potential approval.
SolasCure chairman Andy Weymann said: “This trial is pivotal for fully demonstrating proof-of-concept of efficacy for Aurase Wound Gel with a stronger concentration of the enzyme Tarumase.
“This will help us to establish that the product can achieve complete debridement in 6-9 applications aligned with standard of care and have a positive influence on the rate of healing. This is what the market has been waiting for and brings Aurase Wound Gel a step closer to providing relief to those suffering from chronic wounds worldwide.”
