CAMBRIDGE, England — SolasCure said it has successfully completed a second Phase II clinical trial demonstrating that its investigational Aurase Wound Gel significantly accelerates debridement and healing in patients with chronic venous leg ulcers compared with standard of care.
The Phase II study, known as CLEANVLU2, evaluated Aurase Wound Gel in patients with treatment-resistant, sloughy venous leg ulcers and confirmed both efficacy and dose response. According to the company, the therapy achieved debridement rates up to 22 times faster and healing rates up to seven times faster than standard treatment approaches, which include hydrogel therapy combined with advanced dressings and compression bandaging.
Aurase Wound Gel combines a proprietary hydrogel formulation with the active pharmaceutical ingredient tarumase. In the CLEANVLU2 study, higher concentrations of tarumase resulted in significantly improved outcomes. After 26 days of treatment, patients receiving Aurase Wound Gel achieved 65 percent debridement compared with 9 percent in the control group, and a 58 percent reduction in wound area compared with 15 percent in controls. Both results were statistically significant.
The data also support a dual mechanism of action, the company said. In addition to continuously removing necrotic tissue, tarumase activates PAR2 receptors involved in tissue repair, triggering healing pathways from the first application. SolasCure reported that Aurase Wound Gel maintained a strong safety profile, caused no additional pain, and was associated with improvements in patient quality of life across physical, psychological, and daily living measures.
The CLEANVLU2 findings build on results from the earlier Phase IIa CLEANVLU1 study, which established proof of concept, safety, and pain-free application of the therapy.
Chronic wounds affect millions of patients worldwide and represent a growing burden on healthcare systems. SolasCure said current treatments often focus on wound bed preparation without directly stimulating the biological processes required for healing. The company said the Phase II results support continued development of Aurase Wound Gel as a single therapeutic capable of addressing debridement, wound bed preparation, and sustained healing.
Full clinical data from the CLEANVLU2 trial will be submitted for peer-reviewed publication.
“These Phase II results represent a highly encouraging advance in the treatment of chronic wounds,” said Rob Kirsner, M.D., Ph.D., head of SolasCure’s medical advisory board and chairman and Harvey Blank Professor of Dermatology at the University of Miami. “From a clinical perspective, the data demonstrate very effective debridement alongside meaningful activation of the biological processes leading to healing.”
