SolasCure’s Aurase Clinical Trial is Now Complete

SOLASCURE Ltd.’s investigational Aurase Wound Gel (AWG) heals chronic woulds at a faster rate than current methods, according to data from the company’s now-completed Phase II clinical trial, CLEANVLU2. The trial results provide clinical validation of AWG’s ability to deliver continuous enzymatic debridement while simultaneously activating wound healing.

AWG combines a proprietary hydrogel formulation with the active pharmaceutical ingredient (API) tarumase. After the earlier Phase IIa clinical study, CLEANVLU,¹ which established proof of 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.² At higher concentrations of tarumase, AWG demonstrated significantly enhanced clinical activity, debriding sloughy wounds 22 times faster and achieving rates of healing seven times faster than the standard of care (hydrogel in combination with advanced moist wound healing dressings and compression bandaging systems). After 26 days, AWG achieved 65% debridement versus 9% in control (p=0.005) and 58% wound area reduction versus 15% in control (p=0.022).

“These Phase II 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,” stated Rob Kirsner, M.D., Ph.D., head of Medical Advisory Board at SolasCure, chairman and Harvey Blank Professor of Dermatology at the University of Miami.

The results indicate a dual mechanism of action where, in addition to continuously removing necrotic tissue, API tarumase activates PAR2 receptors involved in tissue repair, initiating healing pathways from the first application. AWG maintained an excellent safety profile, caused no additional pain to patients, and was associated with improvements in quality of life across physical, psychological, and daily living measures, the study results indicate.

Chronic wounds remain a significant and growing unmet medical need, affecting millions of patients worldwide and placing a substantial burden on healthcare systems. Current therapies primarily focus on wound bed preparation rather than directly stimulating the biological processes required for healing. This clinical milestone highlights the potential of AWG to address wound bed preparation, debridement, and sustained healing within a single therapeutic, supporting further development and engagement with investors and strategic partners, company bigwigs said.

Full clinical data from CLEANVLU2 will be submitted for peer-reviewed publication. 

SolasCure is a clinical-stage biotechnology company developing a dual-action therapeutic for chronic wounds. Its lead investigational therapy, Aurase Wound Gel, combines continuous enzymatic debridement with activation of endogenous repair pathways through PAR2 signaling. SolasCure was founded in 2017 as a spin-off from BRAIN Biotech AG, a German biotech company harnessing biological diversity to develop innovative solutions. SolasCure is headquartered in Cambridge, U.K.

References
¹ Fairlamb, D. M., Szepeshazi, K., Goldsmith, D., Danos, P., Lev-Tov, H., Young, N., Hanft, J., & Zelen, C. (2024). First clinical evaluation of the safety and efficacy of tarumase for the debridement of venous leg ulcers. International wound journal, 21(3), e14805. https://doi.org/10.1111/iwj.14805  
² https://www.isrctn.com/ISRCTN59816814