SolasCure’s Aurase Wound Gel Earns FDA Fast Track Designation

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SolasCure Ltd.’s investigational Aurase Wound Gel (AWG) for treating calciphylaxis ulcers. The designation recognizes the potential of AWG in treating this new indication, widening its application in healing chronic wounds while expediting the product’s speed to market.

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 rate,¹²³ 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 that releases 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 treating venous leg ulcers, having established proof-of-concept, a strong safety profile, and pain-free application.⁴

“Given the unmet medical need and the poor outcomes for patients with calciphylaxis, the FDA’s granting Fast Track Designation is a significant milestone,” SolasCure Chief Development Officer David Fairlamb said. “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.”

SolasCure is a biologics company committed to addressing the issue of inadequate debridement and healing solutions for chronic wounds. Its product, Aurase Wound Gel, incorporates the biomimicry of medical maggots’ natural processes that clean wounds and promote healing. Cambridge, U.K.-based SolasCure was founded in 2017 as a spin-off from BRAIN Biotech AG, a leading German biotech company focused on harnessing biological diversity to develop innovative solutions.

References
¹ Nigwekar SU, Thadhani R, Brandenburg VM. Calciphylaxis. N Engl J Med. 2018;379:399-400.
² Udomkarnjananun S, Kongnatthasate K, Praditpornsilpa K, Eiam-Ong S, Jaber BL, Susantitaphong P. Treatment of Calciphylaxis in CKD: A Systematic Review and Meta-analysis. Kidney Int Rep. 2019;4:231-44.
³ Chinnadurai R, Huckle A, Hegarty J, Kalra PA, Sinha S. Calciphylaxis in end-stage kidney disease: outcome data from the United Kingdom Calciphylaxis Study. J Nephrol. 2021;34:1537-45.
⁴ Fairlamb, D. M., Szepeshazi, K., Goldsmith, D., Danos, P., Lev-Tov, H., Young, N., Hanft, J., & Zelen, C. (2024). First clinical evaluation of the safety and efficacy of tarumase for the debridement of venous leg ulcers. International wound journal, 21(3), e14805. https://doi.org/10.1111/iwj.14805