Wound care clinicians are in urgent need of high impact, safe, pain-free and easy-to-use therapeutic treatments to help chronic wounds to heal faster. Despite the ever-increasing choice of new treatments to debride these wounds (a critical prerequisite to healing) and the hard work of the dedicated clinicians using them, healing rates have hardly improved. Existing debridement treatments are either typically rapid, but painful for patients or alternatively, painfree, but slow and ineffective. Importantly, most of these debridement treatments are not fundamentally therapeutic. This means that they only address the symptoms of the wound to “manage” it, rather than treating the underlying tissue which is needed for the wound to actually heal.

Enzymes present a major opportunity to provide clinicians with the treatments they’ve been seeking to improve healing rates, as they offer a compelling range of potential benefits which lend themselves to effective debridement and wound bed preparation. The use of a topical enzyme, especially one that has evolved over millennia for this exact use, provides wound care clinicians with an opportunity to leverage rapid, effective, painless and inexpensive clinical debridement of chronic wounds, whilst simultaneously disrupting the formation of bacterial biofilms in the wound. Moreover, by combining the effects of an enzyme with a source of moisture (which simultaneously optimises the wound environment), newer enzyme formulations have the potential to unlock the potential holy grail of faster chronic wound healing.

Over the last decade, several clinical papers have espoused the benefits of achieving complete debridement, and many of these reports have indicated that more improved healing outcomes can be achieved by debriding the wound more often - at least twice weekly. Simply put, a single debridement procedure, whilst removing the immediate barriers to healing, does not remove the underlying pathology that causes the slough and eschar in the first place. Experience dictates that within hours of surgical debridement, the wound is re-colonised, bacterial biofilms begin to form again and in several days the wound begins to re-slough. Thus the cycle of delayed healing begins once again. To achieve better wound outcomes, clinicians currently face an unenviable task - either initiating repeated painful debridements or employing less painful but less effective autolytic techniques.

At SolasCure we are developing Aurase Wound Gel, which contains the active enzyme tarumase - a protease originally isolated from maggot saliva that selectively targets fibrin and fibronectin in wounds. By combining tarumase with a proprietary hydrogel,  SolasCure harnesses an enzyme that nature has evolved over millennia to optimally digest non-viable tissue in wounds. Tarumase has now been sequenced, cloned and is manufactured by SolasCure through recombinant technology. Our preclinical and clinical testing has demonstrated that this enzyme is not only effective in liquifying non-viable tissue, but also can be applied pain-free, and disrupts biofilm to help control infection. It has no adverse enzymatic action on intact skin, nor does it pose a risk for causing systemic side effects. Importantly, we believe this enzyme product can be used throughout the wound healing process, to not only remove initial slough but to prevent its recurrence in the wound. As the wound begins to heal, the pH of the wound falls from chronic wound pH 7-9 to that more akin to intact skin (pH 4-5) at which point the enzyme becomes deactivated.

There is huge potential for enzymes to treat chronic wounds and improve clinical outcomes for patients, especially as we shift more towards wound therapy (treating the underlying tissue), and away from wound care (treating the symptoms). Aurase Wound Gel aims to provide the best of both enzymatic debridement (rapid debridement over multiple applications) with painless action and a hydrogel that provides moisture to the wound bed. This not only provides for synergistic enzymatic and autolytic debridement effects, but also optimises the wound environment for healing. Clinicians should not be forced to choose between painful but effective debridement and painless but less effective options, and we believe that enzymes offer a solution to unlock better clinical outcomes for patients.

Author: David Fairlamb, Chief Development Officer

David has 30+ years working in drug and medical device industries (Smith & Nephew, Merck KgA, Renovo plc) and in private consultancy (ProTherax Ltd), specialising in supporting the development and regulatory approval of biotechnology, new chemical entities, drug re-purposing and drug/device borderline products, most notably in wound care and dermatology indications. At SolasCure, David ensures all development studies are designed to meet the expectations of regulators, potential partners and investors, so that SolasCure can demonstrate that Aurase Wound Gel is of the required quality for its intended use, is safe for use in patients and that it will be clinically effective for wound debridement and wound bed preparation.