SolasCure has completed its second phase 2 clinical trial of Aurase Wound Gel, reporting results that indicate substantially faster healing in patients with chronic venous leg ulcers.
The company said the CLEANVLU2 study provides clinical validation that the investigational treatment can deliver continuous enzymatic debridement while also activating wound healing.
Aurase Wound Gel combines a proprietary hydrogel with the active pharmaceutical ingredient tarumase. CLEANVLU2 followed the earlier phase 2a CLEANVLU1 study, which established proof of concept and showed a strong safety profile and pain‑free application. The new trial evaluated efficacy and dose response in patients with treatment‑resistant venous leg ulcers.
At higher concentrations of tarumase, the gel debrided sloughy wounds 22 times faster and achieved healing rates seven times faster than standard of care. After 26 days, the treatment achieved 65% debridement compared with 9% in the control group, and 58% wound area reduction compared with 15% in control.
The company said the findings support a dual mechanism of action, with tarumase not only removing necrotic tissue but also activating PAR2 receptors involved in tissue repair. According to SolasCure, this initiates healing pathways from the first application.
The treatment maintained an excellent safety profile, caused no additional pain and was associated with improvements in quality of life across physical, psychological and daily living measures.
Chronic wounds remain a major unmet medical need, placing a significant burden on healthcare systems. SolasCure said the results highlight the potential of Aurase Wound Gel to address wound bed preparation, debridement and sustained healing within a single therapeutic, supporting further development and engagement with partners.
Rob Kirsner, Head of Medical Advisory Board at SolasCure, commented: “These phase 2 results represent a highly encouraging advance in the treatment of chronic wounds. From a clinical perspective, the data demonstrate very effective debridement alongside meaningful activation of the biological processes leading to healing.”
