- Publication in the ‘International Wound Journal’ provides robust validation of the Phase IIa trial data that will enable further clinical studies
- Study demonstrates proof-of-concept and strong safety profile of Aurase Wound Gel in patients suffering from chronic wounds
Cambridge, UK 04 March 2024: SOLASCURE Ltd (SolasCure), a biotechnology company developing a novel treatment to transform chronic wound care, has today announced the publication of its CLEANVLU Phase IIa clinical trial report in the International Wound Journal, a leading wound care journal.1 SolasCure’s first investigational product, Aurase Wound Gel, is a hydrogel releasing tarumase (provisional INN), a recombinant enzyme derived from medical maggots, which aims to promote wound healing through debridement and wound bed preparation. The Phase IIa data, which demonstrates proof-of-concept and safety of Aurase Wound Gel in humans, has now been peer-reviewed and published, providing strong validation as SolasCure progresses into further clinical studies, and marks a significant milestone for the Company.
Chronic wounds are a major healthcare challenge, with around 100 million people suffering from these wounds globally. This represents a significant unmet need as patients and healthcare systems lack safe, pain-free, and effective treatment solutions. Recent clinical data suggest that, after 20 weeks of the current standard of care treatment, complete wound closure is achieved in as little as 25%–50% of chronic or hard-to-heal wounds.2 Aurase Wound Gel aims to address this global challenge by being the first treatment to target all elements of wound bed preparation: debridement, moisture provision, infection control and overall promotion of healing.
SolasCure’s CLEANVLU Phase IIa trial was performed in venous leg ulcer (VLU) patients across centers in the US, UK, and Hungary. The trial compared five escalating dose concentrations to baseline the use of tarumase for enzymatic debridement and wound bed preparation. Patients were treated three times per week, for four weeks. The study established proof-of-concept that tarumase successfully debrides wounds, with faster and more complete debridement and improved healing observed at increased enzyme concentrations. The trial also demonstrated a strong safety profile, with no indications of systemic absorption, antibody generation, or systemic effects on coagulation. Significantly, application of Aurase Wound Gel was shown to be pain-free, did not add to the patients’ existing pain burden, and had no evidence of local tolerability issues.
Further Phase II studies plan to use randomized controlled groups over a longer period, with stratification for factors that may affect debridement and wound healing, to explore the efficacy of tarumase at higher concentrations.
Andy Weymann MD, MBA, Chairman of the Board, SolasCure, commented: “The opportunity for Aurase Wound Gel to truly transform chronic wound care is very exciting, as no other treatment to date aims to target all elements of wound care management in a single product. The peer-review publication of our Phase IIa data not only provides important validation to enable further Phase II studies, but also highlights the clinical potential of Aurase Wound Gel to treat millions of patients globally safely and effectively, addressing an urgent and unmet medical need. With this excellent data we are now fundraising to support the next phase of SolasCure’s clinical and product development.”
Rob Kirsner, MD, PhD, Head of Medical Advisory Board at SolasCure, Chairman and Harvey Blank Professor of Dermatology at the University of Miami, said: “Debridement is a key first step of successful wound bed preparation, itself a prerequisite for wound healing. Achieving timely complete and pain-free debridement which is agnostic of the patient setting is an urgent unmet medical need. SolasCure’s Aurase Wound Gel has shown in this publication positive safety and proof-of-concept results, which bring this product a significant step closer to providing relief to those suffering from chronic wounds worldwide.”
For more information about SolasCure, please visit: https://solascure.com/.
References
- 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
- Falanga, V. et al. (2022) ‘Chronic wounds’, Nature Reviews Disease Primers, 8(1). doi:10.1038/s41572-022-00377-3
