Phase II Trial Enrollment Begins for Aurase Wound Gel

SolasCure Ltd. (SolasCure) has enrolled the first patient in a new Phase II clinical trial (CLEANVLU2), which will evaluate the efficacy of its Aurase Wound Gel in chronic wound treatment.

SolasCure’s Aurase hydrogel releases 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 randomized controlled trial will explore the efficacy of Tarumase at a 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 six weeks of the current standard 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 administered in association with South Leicestershire Medical Group, U.K., 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. 

“This trial is pivotal for fully demonstrating proof-of-concept of efficacy for Aurase Wound Gel with a stronger concentration of the enzyme Tarumase,” SolasCure Board Chairman Andy Weymann M.D., said. “This will help us establish that the product can achieve complete debridement in six to nine 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.”     

SolasCure is a biotechnology company developing chronic wound healing treatment technology.

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 Probst, S., Müller, M., Gerber, V., Weller, C. D., & Ademi, Z. (2023). Prevalence and incidence of venous leg ulcers—a systematic review and meta-analysis. International Wound Journal, 20(9), 3906–3921. https://doi.org/10.1111/iwj.14272