Home Medizin SolasCure veröffentlicht Bericht über klinische Studien der Phase IIa in der führenden Fachzeitschrift für Wundversorgung

SolasCure veröffentlicht Bericht über klinische Studien der Phase IIa in der führenden Fachzeitschrift für Wundversorgung

von NFI Redaktion

SolasCure Ltd (SolasCure), a biotechnology company developing a novel treatment to transform the care of chronic wounds, has announced the publication of its Phase IIa clinical trial report, CLEANVLU, in the International Wound Journal, a leading wound care publication.

SolasCure’s first investigational product, Aurase Wound Gel, is a hydrogel that releases Tarumase (provisional INN), a recombinant enzyme derived from medicinal maggots, aimed at promoting wound healing through debridement and wound bed preparation.

The Phase IIa data demonstrating the efficacy and safety of Aurase Wound Gel in humans have now been peer-reviewed and published, providing strong validation as SolasCure advances into further clinical trials and marking an important milestone for the company.

Chronic wounds pose a significant challenge to healthcare, with approximately 100 million people worldwide suffering from these wounds. This represents a substantial unmet need as patients and healthcare systems lack safe, painless, and effective treatment solutions.

Current clinical data suggests that only 25-50% of chronic or hard-to-heal wounds achieve complete wound closure after 20 weeks of current standard care. Aurase Wound Gel aims to address this global challenge by considering all elements of wound bed preparation: debridement, moisture management, infection control, and overall healing promotion.

SolasCure’s Phase IIa study, CLEANVLU, was conducted on patients with venous leg ulcers (VLU) at centers in the USA, UK, and Hungary. The study compared five escalating dose concentrations with baseline use of Tarumase for enzymatic debridement and wound bed preparation, treating patients three times a week for four weeks.

The study demonstrated proof-of-concept that Tarumase successfully debrides wounds, with higher enzyme concentrations showing quicker and more complete debridement and improved healing. The study also showed a strong safety profile with no evidence of systemic absorption, antibody formation, or systemic effects on coagulation.

Notably, the application of Aurase Wound Gel was painless, did not increase existing pain burden of patients, and showed no signs of local tolerability issues.

Further Phase II studies are planned to use randomized controlled groups over a longer period with stratification based on factors that may influence debridement and wound healing to investigate the efficacy of Tarumase at higher concentrations.

„The opportunity for Aurase Wound Gel to truly change chronic wound care is very exciting, as no other treatment has aimed to cover all elements of wound care in a single product. The peer-reviewed publication of our Phase IIa data not only provides important validation to enable further Phase II studies but also underscores the clinical potential of Aurase Wound Gel to safely and effectively treat millions of patients worldwide, addressing an urgent and unmet medical need. With these outstanding data, we are now raising funds to support SolasCure’s next phase of clinical and product development.“

Andy Weymann MD, MBA, Chairman, SolasCure

„Debridement is a crucial first step in successful wound bed preparation and a prerequisite for wound healing. Timely, complete, and painless debridement, regardless of the patient’s situation, is an urgent, unmet medical need. SolasCure’s Aurase Wound Gel has shown positive safety and proof-of-concept results in this publication, bringing relief for chronic wounds worldwide one step closer.“

Rob Kirsner, MD, Ph.D., Chair of the Medical Advisory Board at SolasCure, Chairman and Harvey Blank Professor of Dermatology at the University of Miami

For more information on SolasCure, visit: https://solascure.com/.

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