SolasCure, a biotechnology company focused on developing novel treatments to improve the healing of chronic wounds, today announced the initiation of its Phase II clinical trial CLEANVLU2 and the successful recruitment of the first patient. This milestone marks an important step forward in the development of SolasCure's investigational product, Aurase Wound Gel, in the treatment of chronic wounds.

Aurase wound gel is an innovative hydrogel whose core ingredient, Tarumase, is a recombinant enzyme cloned from medical maggots. This enzyme is selective and can target fibrin, collagen, and elastin in wounds to promote healing through debridement and wound bed preparation. The previous Phase IIa clinical study, CLEANVLU, has established proof of concept and demonstrated the safety and painless application of Aurase wound gel, while the new CLEANVLU2 trial will further explore the efficacy of Tarumase at higher concentrations in patients with venous leg ulcers.

Globally, there are a large number of patients with chronic wounds, approximately 100 million people, which has become a major healthcare challenge. Due to the limited safe, painless, and effective treatments, many patients suffer from chronic wounds for a long time. Clinical data show that after 6 weeks of the current standard of care treatment, only 41% of chronic or difficult-to-heal wounds can achieve overall wound closure. Therefore, the CLEANVLU2 trial will generate key efficacy data, providing strong evidence for Aurase Wound Gel as the first treatment method that can comprehensively handle wound bed preparation (including debridement), and also provide an important reference for investors and potential strategic partners.

The trial was conducted in conjunction with the South Leicestershire Healthcare Group in the UK as part of the group's community services. After the trial is completed, SolasCure plans to conduct further Phase II studies over a longer period of time to conduct stratified analyses of factors that may affect debridement and wound healing. Subsequently, the company will enter a confirmatory Phase III clinical trial to seek regulatory approval.

"This trial is critical to fully demonstrate the effectiveness of Aurase Wound Gel, especially as we increase the concentration of the Tarumase enzyme," said Andy Weymann, M.D., M.B.A., Chairman of the Board of SolasCure. "This trial will determine if the product can achieve complete debridement in 6-9 applications, consistent withthe  standard of care, and positively impact healing rates. This is the result the market has been waiting for and will bring Aurase Wound Gel one step closer to providing relief to chronic wound patients around the world."

SolasCure is confident in the research and development of Aurase Wound Gel and looks forward to further verifying its efficacy and safety through this Phase II clinical trial, bringing new treatment hope to patients with chronic wounds.