Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has granted fast track designation to SolasCure's investigational Aurase Wound Gel (AWG) for treating calciphylaxis ulcers.
The fast track status signifies the potential of the gel to broaden its therapeutic applications in chronic wound healing, accelerating its availability to patients. Credit: Diana Polekhina on Unsplash.
Subscribe to our email newsletter
This status signifies the potential of the gel to broaden its therapeutic applications in chronic wound healing, accelerating its availability to patients.
SolasCure noted that this hydrogel releases recombinant enzyme, Tarumase, that targets collagen, fibrin, and elastin in wounds, promoting healing via debridement and wound bed preparation.
At present, the gel is in Phase II trials to treat venous leg ulcers and has shown a pain-free application and safety profile.
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.”
According to the company, calciphylaxis is characterised by the calcification of small blood vessels in the fat and skin tissues, resulting in painful skin ulcers and blood clots, and the potential to advance to sepsis and severe infections.
While it is most often linked to end-stage renal disease, it can also affect people with normal kidney function.
AWG presents a new debridement solution that could minimise the infection and sepsis risk, offering a treatment option for patients who may be too fragile for the existing standard of care.
The fast track designation will enable drug development and accelerate the review process, addressing substantial unmet medical requirements, and promote close communication with the agency.
