Aurealis Therapeutics has announced that the first diabetic foot ulcer (DFU) patient has been dosed with AUP-16, its three-in-one combination biologic drug for chronic non-healing wounds and regenerative diseases. The trial, currently being performed in non-healing DFU patients, is designed to evaluate the safety, tolerability and preliminary efficacy of a repeated, dose-escalating administration of AUP-16.
According to a statement, the primary objective of the trial is to determine the safety and tolerability of AUP-16 and the recommended dose for an 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 the increasing incidence of diabetes, obesity, vascular disease and ageing. Affected patients deserve new effective therapies to stop this devastating condition that, if untreated, can lead to infection, gangrene, amputation and death” said Christoph Schindler from Medizinische Hochschule Hannover (MHH), Hannover, Germany.
Schindler global coordinating investigator for this trial, added: “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.” said Thomas Wirth, CSO and chairman of the board of Aurealis Therapeutics.
“Advanced wound care is today a US$15 billion annual market and is expected to grow to a US$25 billion 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,” continued Juha Yrjänheikki, CEO of Aurealis Therapeutics and Roger Meier, board director and a long-time advisor of the company.