The trial aims to investigate the efficacy of Tarumase’s higher concentration in subjects with venous leg ulcers. Credit: Copyright © 2024 Solascure Limited.
UK biotechnology company SolasCure has commenced the randomised, controlled CLEANVLU2 Phase II trial of Aurase Wound Gel for chronic wound treatment, with the first subject enrolled.
The patented biomimetic product has Tarumase, a clone of medical maggots’ enzyme that functions by breaking down the fibrin, elastin, and collagen in wounds, facilitating healing via debridement.
CLEANVLU2 aims to build on the success of the initial Phase IIa study, which demonstrated the product’s safety and pain-free application, by investigating the efficacy of Tarumase’s higher concentration in subjects with venous leg ulcers.
The gel is designed to be a ‘safe’ debrider suitable for all patient settings.
According to the company, the CLEANVLU2 trial is set to provide crucial efficacy data to further establish the gel’s potential as the ‘first’ treatment in addressing all aspects of wound bed preparation, including debridement.
As part of the community service, the trial is being conducted in collaboration with the UK’s South Leicestershire Medical Group.
Following the completion of the current trial, the company plans to conduct another Phase II trial over a longer time, which will include stratification for factors that may influence debridement as well as healing of the wound. This will precede the confirmatory Phase III trials necessary for regulatory approval.
With approximately 100 million individuals affected by chronic wounds worldwide, there is a significant need for ‘safe’, pain-free treatments.
SolasCure board chairman Andy Weymann said: “This trial is pivotal for fully demonstrating proof-of-concept of efficacy for the 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 six to nine applications aligned with the standard of care and have a positive influence on the rate of healing. This is what the market has been waiting for and brings the Aurase wound gel a step closer to providing relief to those suffering from chronic wounds worldwide.”
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