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Tarumase for the Debridement of Venous Leg Ulcers: CLEANVLU Phase IIa

Published: 21 Mar 2024

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We are joined by Mr David Fairlamb (SolasCure) to discuss the findings of the CLEANVLU Phase IIa study, which investigated the use of a hydrogel containing the proteolytic enzyme tarumase (Aurase Wound Gel, SolasCure) for the debridement of venous leg ulcers in patients in the UK, United States, and Hungary.

This dose-escalated, first-in-human study enrolled 43 patients with sloughy venous leg ulcers, who received standard of care supplemented with increasing concentrations of wound gel. The patients were assessed for clinical tolerability at the wound site, as well as the safety and efficacy of the wound gel in practice over a period of 4 weeks.

Interview Questions:

  1. What are the unmet needs for venous leg ulcer patients in 2024?
  2. Could you tell us a bit more about tarumase and the experimental hydrogel?
  3. What was the study design and patient population?
  4. What are your key findings?
  5. What are the next steps?

Recorded remotely from Cambridge, 2024.

Editor: Jordan Rance
Video Specialist: Dan Brent, Oliver Miles

Transcript

"My name is David Fairlamb. I'm part of the clinical team at Solascure, director of regulatory affairs, developing Aurase wound gel for the treatment of debridement for venous leg ulcers.

What are the unmet needs for venous leg ulcer patients in 2024?

Debridement is crucial for wound healing, and without it, healing can be delayed. Unfortunately, there's no consistent standard of care worldwide. While surgical debridement is prevalent in certain markets, outside the US, most patients receive moist wound healing dressings utilizing autolytic debridement, which is slow, resulting in delayed healing.

This lack of standard care is a significant unmet need, particularly considering that these patients are primarily in the community. Hence, we need easily applicable products that nurses can use, not just in hospitals but also in clinics or patients' homes. These products should align with standard care dressing changes and not affect the viable wound bed, factors critical for venous leg ulcers, where patients lack consistent standard care.

Could you tell us a bit more about tarumase and the experimental hydrogel?

Our enzyme, Tarumase, is derived from maggot saliva and has been cloned and produced recombinantly. It's a fibrinolytic selective enzyme with action on collagen and elastin, making it suitable for chronic wound debridement. Unlike previous enzymes used for debridement, Tarumase isn't painful or immunogenic, addressing significant concerns in this domain.

Tarumase is incorporated into a hydrogel, commonly used for autolytic debridement, creating synergy between enzymatic activity and moisture, promoting faster and more effective debridement while aiding healing.

What was the study design and patient population?

Our first clinical trial primarily focused on safety, escalating the Tarumase concentration to assess safety and efficacy in venous leg ulcer patients with sloughy wounds. We monitored pharmacokinetics, systemic clotting effects, and local tolerability, finding no systemic issues or adverse local effects.

What are your key findings?

Though primarily a safety trial, we observed increased debridement rates and enhanced healing with higher Tarumase concentrations, prompting further investigation into higher doses and a randomized controlled trial to assess efficacy comprehensively.

What are the next steps?

We're open to discussing these trial results and ensuring patient access to our products. Please feel free to reach out if you'd like to learn more.”

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