CAMBRIDGE, England– SolasCure, a UK-based biotechnology company focused on advanced wound care, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its investigational therapy Aurase Wound Gel (AWG) in the treatment of calciphylaxis ulcers—a rare, life-threatening condition with limited treatment options.
The designation is a significant milestone for SolasCure, accelerating the development and review of AWG for a new clinical indication. The company is already conducting Phase II trials of AWG for venous leg ulcers, and this new approval could expand its application to patients suffering from calciphylaxis—a disease that causes painful skin ulcers due to the calcification of small blood vessels, and carries a high risk of infection and sepsis.
“Given the unmet medical need and the poor outcomes for patients with calciphylaxis, the FDA’s granting Fast Track Designation is a significant milestone,” said David Fairlamb, Chief Development Officer at SolasCure. “This not only highlights the promise of Aurase Wound Gel but expands its potential to help a broader patient population.”
Aurase Wound Gel works by releasing Tarumase, a recombinant enzyme derived from medical maggots. This enzyme targets key structural proteins—fibrin, collagen, and elastin—within the wound bed, promoting healing through gentle, selective debridement. Its non-invasive and pain-free application may prove especially valuable for calciphylaxis patients who are often too fragile for traditional wound care.
Calciphylaxis primarily affects individuals with end-stage kidney disease but can also appear in patients with normal kidney function. With no established treatment protocol and a high one-year mortality rate, the FDA’s designation signals a promising step toward improving outcomes for these high-risk patients.
The Fast Track status will enable closer collaboration between SolasCure and the FDA, potentially speeding the path to approval and ultimately helping more patients gain access to this novel therapy.
