Phase II clinical trial to determine the efficacy of Aurase Wound Gel at a higher concentration of the active enzyme Tarumase in venous leg ulcers
SOLASCURE Ltd (SolasCure), a biotechnology company developing a novel treatment to transform chronic wound healing, today announced the initiation of a new Phase II clinical trial, CLEANVLU2. The enrolment of the trial’s first patient marks a new clinical milestone in the development of its investigational product, Aurase Wound Gel, for the treatment of chronic wounds.
Aurase Wound Gel is a hydrogel releasing Tarumase, a recombinant enzyme originally cloned from medical maggots that selectively targets fibrin, collagen and elastin in wounds to promote healing through debridement and wound bed preparation. CLEANVLU2 adds further insight to the successful Phase IIa clinical study, CLEANVLU 1, which established proof-of-concept, a strong safety profile and pain-free application. The new randomised controlled trial will explore the efficacy of Tarumase at higher concentration, in patients with venous leg ulcers.
Chronic wounds affect around 100 million people globally, representing a significant healthcare challenge with limited safe, pain-free, and effective treatments. Clinical data suggest that, after 6 weeks of the current standard of care treatment, overall wound closure is achieved in as little as 41% of chronic or hard-to-heal wounds 2. This trial will generate key efficacy data to further demonstrate Aurase Wound Gel’s potential as the first treatment to address all aspects of wound bed preparation including debridement, informing investors and potential strategic partners.
The trial is being run in association with South Leicestershire Medical Group, UK, as part of its community service. Once the CLEANVLU2 study is completed, a further Phase II study is planned over a longer period, with stratification for factors that may affect debridement and wound healing, before moving into confirmatory clinical Phase III trials for regulatory approval.
Andy Weymann MD, MBA, Chairman of the Board, SolasCure 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.”
Discover the latest trends and insights—explore the Business Insights Journal for up-to-date strategies and industry breakthroughs!
