SolasCure Receives FDA Fast Track Designation for Aurase Wound Gel in Treatment of Calciphylaxis Ulcers

SolasCure Ltd, a UK-based biotechnology firm focused on advancing chronic wound care, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational drug Aurase Wound Gel (AWG) for the treatment of calciphylaxis ulcers, a severe and life-threatening condition with limited treatment options.

The Fast Track status is a significant regulatory milestone, aimed at accelerating the development and review process of therapies that address serious conditions with unmet medical needs. It paves the way for closer collaboration between SolasCure and the FDA, potentially expediting AWG’s path to market and increasing access for patients facing this rare condition.

A Rare and Devastating Disease

Calciphylaxis is a rare disorder marked by the calcification of small blood vessels in the skin and fat, leading to blood clots, painful ulcers, and high risk of infection or sepsis. It most frequently affects patients with end-stage renal disease but can also occur in others without kidney dysfunction. The one-year mortality rate remains alarmingly high, and effective treatment options are scarce.

SolasCure’s Aurase Wound Gel offers a promising alternative. The hydrogel contains Tarumase, a recombinant enzyme inspired by compounds found in medical maggots, known for their ability to break down necrotic tissue. AWG targets proteins like fibrin, collagen, and elastin to gently debride wounds and prepare them for healing, with the goal of reducing the risk of infection and improving outcomes for patients too fragile to tolerate conventional debridement methods.

Expanding Clinical Promise

Already in Phase II clinical trials for venous leg ulcers, Aurase Wound Gel has demonstrated a strong safety profile, effective debridement, and pain-free application. The new Fast Track Designation represents an expansion of AWG’s potential indications, supporting its use in the treatment of more complex and life-threatening wounds such as calciphylaxis ulcers.

“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. “Not only does it reflect the promise of Aurase Wound Gel in the treatment of calciphylaxis ulcers, but it also adds a new indication, increasing its potential to help more patients, therefore opening up an even larger target market for SolasCure.”

This designation could accelerate development timelines, making Aurase Wound Gel available sooner to those most in need. The company plans to work closely with the FDA to advance the product through clinical development and regulatory review.

About SolasCure

SolasCure is a biotechnology company dedicated to developing innovative solutions to advance wound care. Its lead candidate, Aurase Wound Gel, leverages biomimicry to enable selective, enzymatic debridement that is safe, effective, and patient-friendly.