SolasCure Ltd has announced the enrollment of the first patient in CLEANVLU2, a new Phase II clinical trial for its investigational product Aurase Wound Gel. This milestone advances the development of a novel treatment aimed at transforming chronic wound healing, particularly for patients with venous leg ulcers.
Aurase Wound Gel utilizes Tarumase, a recombinant enzyme originally cloned from medical maggots, which selectively targets fibrin, collagen, and elastin in wounds. This selective targeting promotes healing through debridement and wound bed preparation, addressing a critical need in chronic wound management.
Building on Previous Clinical Success
The new randomized controlled trial builds upon SolasCure's successful Phase IIa clinical study, CLEANVLU, which established proof-of-concept, demonstrated a strong safety profile, and confirmed pain-free application. CLEANVLU2 will specifically explore the efficacy of Tarumase at a higher concentration in patients with venous leg ulcers.
"This trial is pivotal for fully demonstrating proof-of-concept of efficacy for Aurase Wound Gel with a stronger concentration of the enzyme Tarumase," said Andy Weymann MD, MBA, Chairman of the Board at SolasCure. "This will help us to establish that the product can achieve complete debridement in 6-9 applications aligned with standard of care and have a positive influence on the rate of healing."
Addressing a Global Healthcare Challenge
Chronic wounds represent a significant healthcare burden, affecting approximately 100 million people worldwide. Current treatment options are limited in terms of safety, comfort, and effectiveness. Clinical data indicate that after six weeks of standard care treatment, overall wound closure is achieved in as little as 41% of chronic or hard-to-heal wounds.
The CLEANVLU2 trial aims to generate key efficacy data to further demonstrate Aurase Wound Gel's potential as the first treatment to comprehensively address all aspects of wound bed preparation, including debridement. These results will be valuable for informing investors and potential strategic partners about the product's capabilities.
Trial Design and Future Plans
The trial is being conducted in association with South Leicestershire Medical Group in the UK as part of its community service. Following the completion of CLEANVLU2, SolasCure plans to conduct an additional Phase II study over a longer period. This extended study will include stratification for factors that may affect debridement and wound healing, before advancing to confirmatory Phase III clinical trials required for regulatory approval.
Innovative Mechanism of Action
What sets Aurase Wound Gel apart is its innovative approach to wound healing. The Tarumase enzyme's ability to selectively target specific proteins in wounds represents a significant advancement in debridement technology. Unlike traditional methods, which can be painful and non-selective, Aurase Wound Gel offers the potential for a pain-free application with targeted action.
The development of Aurase Wound Gel addresses a critical unmet need in wound care management, potentially offering new hope to millions of patients suffering from chronic wounds worldwide. If successful in clinical development, this biotechnology innovation could transform the standard of care for chronic wound treatment, particularly for venous leg ulcers that are often resistant to current therapies.
