Basel Switzerland, Kuopio Finland – February 11th, 2020.
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.
AUP-16 Clinical Plan
Study AP-W-CLI-2018-8 (EudraCT number: 2018-003415-22) is the first clinical study of AUP-16 in humans. It is a Phase 1-2A clinical study to evaluate the safety, tolerability and efficacy of a single and repeated doses of AUP-16 as topical treatment of DFU. The Phase 1 part will be a multicenter, open-label, non-randomized, uncontrolled dose-finding study with sequential dose escalations performed in dose cohorts comparing three doses of AUP-16 administered three times per week (low, medium, and high dose cohorts).
The Phase 2A part, an extension of the Phase 1, will be a multi-center, open-label, randomized, placebo-controlled study of the recommended AUP-16 dose and administration schedule from Phase 1 to confirm safety and to assess efficacy of the selected recommended phase 2 dose and schedule in DFU patients.
AUP-16 is a genetically engineered Lactococcus lactis, a non-pathogenic, probiotic bacteria, expressing human basic fibroblast growth factor (FGF2, bFGF), interleukin-4 (IL4) and macrophage colony stimulating factor (CSF1, mCSF) – all in one product and accepted as one active pharmaceutical ingredient from regulatory perspective. AUP-16 is topically applied on chronic wounds and covered by wound dressing (e.g. in diabetic foot ulcers, venous leg ulcers and pressure ulcers). In the wound AUP-16 acts as millions of bioreactors producing the therapeutic proteins, which are designed to i) halt chronic inflammation in the wound, ii) induce growth of new blood vessels, and iii) promote granulation tissue formation and skin re-epithelization – all in one product.