Phase II trial for SolasCure wound gel

SolasCure has initiated a new Phase II clinical trial, CLEANVLU2, to further the development of its investigational product, Aurase Wound Gel, for the treatment of chronic wounds.

Aurase Wound Gel is a hydrogel releasing 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.

The new randomised controlled CLEANVLU2 trial will explore the efficacy of Tarumase at higher concentration, in patients with venous leg ulcers.

The trial is being run in association with South Leicestershire Medical Group, UK, 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.

At that point the gel starts to become an effective treatment for the 100 million people globally affected by chronic wounds.

These wounds represent a significant healthcare challenge with limited safe, pain-free, and effective treatments.

Clinical data suggests that, after six weeks of the current standard of care treatment, overall wound closure is achieved in as little as 41 per cent of chronic or hard-to-heal wounds.

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.

SolasCure is headquartered in Wellington House on East Road. The private healthcare technology company, which focuses on chronic wound treatments, was founded in 2017 by Rached Bakri.

The company currently has 22 staff and to date has raised $34.2m in funding from 13 investors.

This fundraising success story includes a £15million Series A round in 2021 and a £10.9m Series B round in 2023.

In November 2024, SolasCure began a research collaboration with the US Army Institute of Surgical Research to evaluate Aurase Wound Gel as a means for managing combat wounds.

The collaboration resulted in two non-clinical development projects being initiated to assess the potential for the enzymatic debridement properties of Aurase Wound Gel to reduce wound biofilm production and/or bioburden in conjunction with standard-of-care in prolonged field care scenarios.

Andy Weymann, chairman of the board, SolasCure, said of the Phase II trial announced this week: “This trial is pivotal for fully demonstrating proof-of-concept of efficacy for Aurase Wound Gel with a stronger concentration of the enzyme Tarumase.

“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.

“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.”