Aurealis Therapeutics, a private clinical-stage biopharmaceutical company developing AUP-16, the three-in-one combination biologic drug for chronic non-healing wounds and regenerative diseases, announced today that the first diabetic foot ulcer (DFU) patient has been dosed with AUP-16. The trial is performed in non-healing DFU patients and is designed to evaluate the safety, tolerability and preliminary efficacy of a repeated, dose-escalating administration of AUP-16. The primary objective of the trial is to determine the safety and tolerability of AUP-16 and the recommended dose for the upcoming phase 2 study. In addition, preliminary efficacy data of AUP- 16 in patients with non-healing wounds will be available.

“The medical need in chronic non-healing wounds is already massive and is growing globally due to increasing incidence of diabetes, obesity, vascular disease and aging. Affected patients deserve new effective therapies to stop this devastating condition that, if untreated, can lead to infection, gangrene, amputation and death” said Professor Christoph Schindler from Medizinische Hochschule Hannover (MHH), who is serving as global coordinating investigator for this trial. “We are excited to be part of this Phase 1-2A study evaluating AUP-16, an ATMP gene therapy product that has demonstrated promising potential in preclinical studies”.

“We are extremely excited to dose the first patient in this trial with AUP-16. This is not only a major achievement for Aurealis Therapeutics, but also for synthetic biology based multitherapy drug products such as AUP-16. We are globally the first clinical stage company with a therapeutic product like this – a scalable, genetically engineered bacterial cell therapy that produce and secrete three human therapeutic proteins in the target tissue with an unparalleled low cost-of- goods” said Dr. Thomas Wirth, CSO and Chairman of the Board of Aurealis Therapeutics.

“Advanced wound care is today a 15 billion USD annual market and is expected to grow to a 25 billion USD market in 2026. A novel approach with demonstrated efficacy in this indication holds significant commercial potential. AUP-16 our three-in-one combination biologics product hitting the key wound healing targets - inflammation, proliferation and remodeling - is very different from the past single target therapies and has potential for superior clinical efficacy.

We are grateful to our investors, collaborators and team, and are looking forward to reporting the progress of this patient trial to the scientific community and industry as non-healing diabetic wounds remain a severe and complex disease with no effective therapies” continued Dr. Juha Yrjänheikki, CEO of Aurealis Therapeutics and Mr. Roger Meier, Board Director and a long-time advisor of the company.