SOLASCURE Ltd (SolasCure), a biotechnology company developing a novel treatment to transform chronic wound healing, today announced the successful completion of its second Phase II clinical trial, CLEANVLU2. The study showed that its investigational product, Aurase Wound Gel (AWG), heals chronic wounds at a faster rate than the current standard of care, providing clinical validation of its ability to provide continuous enzymatic cleansing while simultaneously activating wound healing.
AWG combines a proprietary hydrogel formulation with the active pharmaceutical ingredient (API) tarumase. Following a previous Phase IIa clinical study, CLEANVLU, which proved the concept and demonstrated a strong safety profile and pain-free application, CLEANVLU2 further evaluated efficacy and dose response in patients with treatment-resistant venous leg ulcers. At higher tarumase concentrations, AWG demonstrated significantly enhanced clinical activity, clearing wounds 22 times faster and achieving healing rates seven times faster than standard care (hydrogel combined with advanced wound healing dressings and compression dressing systems). After 26 days, AWG achieved 65% clearance vs. 9% control (p=0.005) and 58% wound area reduction vs. 15% control (p=0.022).
The results indicate a dual mechanism of action where, in addition to the continuous removal of necrotic tissue, tarumase API activates PAR2 receptors involved in tissue repair, initiating healing pathways from the first application. AWG maintained an excellent safety profile, caused no additional patient pain, and was associated with improvements in quality of life on physical, psychological, and daily living measures.
Chronic wounds remain a significant and growing unmet medical need, affecting millions of patients worldwide and placing a significant burden on healthcare systems. Current therapies focus primarily on wound bed preparation rather than direct stimulation of the biological processes required for healing. This clinical milestone highlights AWG’s ability to address wound bed preparation, debridement and ongoing healing in a single therapeutic medium, supporting further development and engagement with investors and strategic partners.
Complete clinical data from CLEANVLU2 will be submitted for peer-reviewed publication.
These Phase II results represent a highly encouraging advance in the treatment of chronic wounds. From a clinical point of view, the data demonstrate very effective cleansing alongside the substantial activation of biological processes that lead to healing.”
Rob Kirsner, MD, PhD, SolasCure Medical Advisory Board Chair, President and Harvey Blank Professor of Dermatology, University of Miami
