On June 16, 2025, biotechnology company SolasCure Ltd (hereinafter referred to as "SolasCure") announced that its Aurase Wound Gel (AWG) under development has obtained the U.S. Food and Drug Administration (FDA) Fast Track qualification for the treatment of patients with calcific ulcers. This recognition not only highlights the potential of AWG in the treatment of calcific ulcers but also means that the therapy is expected to enter the market faster, bringing new treatment options to patients.

New hope for rare diseases

Calciphylaxis is a rare but serious disease characterized by calcification of small blood vessels in fat and skin tissue, which can lead to blood clots, painful skin ulcers, and may even develop into severe infection and sepsis. Although the disease is often associated with end-stage renal disease, patients with normal renal function are also susceptible to it. Due to the limited treatment options available and the high one-year mortality rate of patients, the emergence of AWG has brought new hope to patients. As an alternative debridement solution, AWG is expected to reduce the risk of infection and sepsis, providing a new treatment avenue for patients who are too fragile to receive existing standard treatments, thereby improving the prognosis of this vulnerable group.

Potential for innovative treatments

AWG is a hydrogel that releases Tarumase, an enzyme isolated and recombinant from medical maggots. It can selectively target fibrin, collagen, and elastin in wounds, promoting wound healing through debridement and wound bed preparation. Currently, AWG is in Phase II clinical trials for the treatment of venous leg ulcers, and has demonstrated good safety and painless application effects, and has obtained proof of concept. The FDA fast track qualification further demonstrates its potential in the treatment of calcific defense ulcers, expanding SolasCure's target market to a broader range, enabling it to help more patients.

The significance of the FDA fast track

Given the large number of unmet medical needs and poor prognosis of patients with calciphylaxis, the FDA's granting of Fast Track status to AWG is of great significance. This not only reflects the prospects of Aurase wound gel in the treatment of calciphylaxis ulcers, but also means that this therapy is expected to benefit patients more quickly, bringing new hope for improving patients' quality of life.

"The FDA's Fast Track designation is a recognition of the potential of Aurase Wound Gel and the hard work of our research and development team," said David Fairlamb, Chief Development Officer of SolasCure. "We will continue to advance the research and development of Aurase Wound Gel and strive to bring it to market as soon as possible to provide more effective treatment options for patients with calcific ulcers."

SolasCure is a biotechnology company dedicated to developing new therapies to improve the healing of chronic wounds. Driven by innovation, the company continues to explore new treatment pathways to provide patients with safer and more effective treatment options. The FDA's fast track designation for Aurase Wound Gel is another important progress made by the company in the field of chronic wound healing.

Source: SolasCure