SolasCure receives FDA Fast Track Designation for Aurase Wound Gel to treat calciphylaxis ulcers

• Recognises the potential of Aurase Wound Gel to improve outcomes for individuals with calciphylaxis ulcers, a rare and life-threatening condition
• Represents a new indication for Aurase Wound Gel, currently in Phase II Clinical Trials for treatment of venous leg ulcers
• Fast Track is designed to facilitate development and expedite review of drugs to treat significant unmet medical need, fostering closer collaboration with the FDA

SOLASCURE Ltd (SolasCure), a biotechnology company developing a novel treatment to transform chronic wound healing, today announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational Aurase Wound Gel (AWG), in the treatment of patients with calciphylaxis ulcers. The designation recognises the potential of AWG in the treatment of this new indication, widening its application in the healing of chronic wounds whilst expediting the speed at which the new therapy could be available to patients.

Calciphylaxis is a rare but serious condition involving the calcification of small blood vessels in the fat and skin tissues. It leads to blood clots, painful skin ulcers, and can progress to severe infections and sepsis. Although most commonly associated with end-stage renal disease, the condition can also occur in individuals with normal kidney function. With limited treatment options and a high one-year mortality rate¹²³, AWG offers an alternative debridement solution that potentially reduces the risk of infection and sepsis, opening up treatment options for patients previously considered too fragile to receive the current standard of care and improving outcomes in this vulnerable population.

AWG is a hydrogel releasing Tarumase, a recombinant enzyme originally isolated from medical maggots, which selectively targets fibrin, collagen and elastin in wounds to promote healing through debridement and wound bed preparation. It is currently in Phase II Clinical trials for the treatment of venous leg ulcers, having established proof-of-concept, a strong safety profile and pain-free application⁴

David Fairlamb, Chief Development Officer at SolasCure 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."

For more information about SolasCure, please visit: https://solascure.com/.

References

1. https://www.nejm.org/doi/10.1056/NEJMra1505292?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
2. https://pmc.ncbi.nlm.nih.gov/articles/PMC6365410/
3. https://pmc.ncbi.nlm.nih.gov/articles/PMC8494680/
4. https://pmc.ncbi.nlm.nih.gov/articles/PMC10883251/

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