SolasCure has received the US Food and Drug Administration (FDA) Fast Track Designation for its investigational Aurase Wound Gel (AWG) for treating calciphylaxis ulcers.

The Fast Track designation highlights AWG’s potential in addressing chronic wounds and accelerates its availability to patients suffering from this condition.

Calciphylaxis is a severe condition characterised by the calcification of small blood vessels in fat and skin tissues, resulting in blood clots and painful skin ulcers.

It is commonly linked to end-stage renal disease and can also affect individuals with normal kidney function.

AWG offers an alternative debridement solution, reducing infection and sepsis risks.

It provides new treatment options for patients too fragile for the current standard of care, thereby improving outcomes for this vulnerable group.

The gel is a hydrogel that releases Tarumase, a recombinant enzyme derived from medical maggots, which targets fibrin, collagen, and elastin to promote healing.

SolasCure chief development officer David Fairlamb said: “Given the unmet medical need and the poor outcomes for patients with calciphylaxis, the FDA’s granting Fast Track Designation is a significant milestone.

“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.”

Currently, AWG is in Phase 2 clinical trials for venous leg ulcers, having shown proof-of-concept, a strong safety profile, and pain-free application.

The Phase 2 trial, dubbed CLEANVLU2, evaluated the effectiveness of higher concentrations of Tarumase in people with venous leg ulcers.

The study results indicate faster and more complete debridement, improved healing at higher enzyme concentrations, and no systemic absorption or antibody generation.

In addition, the trial showed that AWG does not affect coagulation or increase patients’ pain burden, with no local tolerability issues observed.