Aurealis Therapeutics Receives Clinical Trial Application Approval for AUP-16 Diabetic Foot Ulcer Patient Trial

Aurealis Therapeutics, a private biopharmaceutical company developing AUP-16, the three-in-one combination biologic drug for chronic non-healing wounds and regenerative diseases, announced today clinical trial application (CTA) approval of the AUP-16 phase 1 diabetic foot ulcer (DFU) patient trial by the German Health Authority Paul-Ehrlich-Institute. The company plans to enroll the first patient to the phase 1 DFU patient trial in three months.

“This CTA approval is obviously a major milestone for the company and an exceptional moment for the synthetic biologics industry as this presents globally the first time ever to get an approval for a therapeutic product genetically modified to produce three human therapeutic proteins in the diseased tissue. We are looking forward to initiating the patient enrollment and committed to the clinical development in general as non-healing diabetic wounds remain a severe complex disease with no effective therapies” said Dr. Juha Yrjänheikki, CEO of Aurealis Therapeutics AG.

“It is far from trivial to develop a product like this from discovery lab to the patients in five and a half years. I am extremely proud of our team and all R&D, regulatory and quality control collaborators for developing a clinical grade and scalable ATMP gene therapy product with extremely competitive cost-of-goods” continued Dr. Thomas Wirth, CSO and Chairman of the Board of Aurealis Therapeutics AG.