Aurealis Therapeutics, a clinical-stage Swiss-Finnish company developing multi-target cell and gene therapies for chronic wounds and cancer, is proud to announce the publication of its AUP-16 Phase 1 clinical trial results in the peer-reviewed journal Therapeutic Advances in Endocrinology and Metabolism. The scientific paper, titled “Multi-target gene therapy AUP1602-C to improve healing and quality of life for diabetic foot ulcer patients: a phase 1, open-label, dose-finding study,” presents the exciting potential of AUP-16 as a novel treatment for non-healing diabetic foot ulcers (nhDFUs). The article is available online at https://doi.org/10.1177/20420188241294134.
“We are incredibly proud to share the publication of our Phase 1 study results for AUP-16 in Therapeutic Advances in Endocrinology and Metabolism,” said Juha Yrjänheikki, CEO of Aurealis Therapeutics. “This publication brings the promising data from our study to a wider audience within the global medical and scientific community while highlighting the potential of AUP-16 to meet the unmet medical need of diabetic foot ulcers.”
AUP-16: A Novel Multi-Target Gene Therapy for nhDFUs
Diabetic foot ulcers (DFUs) represent a significant unmet medical need, affecting millions of people worldwide and leading to severe complications, often resulting in reduced quality of life and in some cases even death. Conventional treatments frequently fail to promote effective healing for these types of chronic wounds. AUP-16 addresses this gap with its innovative four-in-one cell and gene therapy, designed to stimulate the tissue’s natural regenerative processes.
Unlike traditional treatments, AUP-16 is a topically administrated multi-target gene therapy developed from genetically engineered Lactococcus cremoris bacteria. Its unique mechanism enables it to locally produce human therapeutic proteins directly at the wound site, allowing for efficient and targeted healing.
Phase 1 Study Results: Safety, Tolerability, and Efficacy
The Phase 1 clinical trial (NCT04281992 / EudraCT 2018-003415-22) was designed to evaluate the safety, tolerability, and preliminary efficacy of AUP-16, as well as to determine the recommended dose for Phase 2 trials. Sixteen patients with nhDFUs participated in the study, receiving either a single dose or repeated doses of AUP-16 three times per week at different concentrations over a six-week period.
The results demonstrated that AUP-16 was well tolerated, with no reports of serious adverse reactions related to the treatment. Nearly 100% of doses were administered as planned, highlighting a high level of patient compliance. Most importantly, 83% of patients who received the recommended Phase 2 dose experienced complete wound healing, with no recurrence observed during the 12-month follow-up period. Game-changing treatments such as AUP-16 are critically needed, as up to 70% of patients with DFUs do not respond to standard treatment and 40% of those who heal recur within 1 year.
“The successful publication of AUP-16 Phase 1 clinical trial is an achievement resulting from the commitment and hard work of our team, partners, and clinical sites,” added Haritha Samaranayake, MD, PhD, Chief Medical Officer of Aurealis Therapeutics. “We celebrate the publication of these results and continue to progress the development of AUP-16, which has now reached the Last Patient Last Treatment milestone in its ongoing Phase 2 “DIAMEND” study (NCT06111183 / EudraCT 2022-502048-10-00).”
The Phase 1 study’s findings highlight AUP-16’s potential as a safe and effective treatment for DFUs and support its further clinical development. AUP-16 offers a cost-effective alternative to existing therapies, addressing an urgent medical need within the diabetic patient community.
About AUP-16
AUP-16 is a genetically engineered Lactococcus cremoris, a non-pathogenic lactic acid bacterium, expressing human basic fibroblast growth factor (FGF-2 / bFGF), interleukin-4 (IL-4) and macrophage colony stimulating factor (CSF-1 / mCSF). AUP–16 is an all-in-one live biotherapeutic product accepted as a single pharmaceutical entity from regulatory perspective and classified as GTMP (Gene Therapy Medicinal Product) in EU and MVGT (Microbial Vector for Gene Therapies) in USA. AUP-16 is topically applied on chronic wounds and covered by wound dressing (e.g. in diabetic foot ulcers, venous leg ulcers or other ulcer types). In the wound AUP-16 acts as millions of bioreactors producing the therapeutic proteins, which are designed to i) activate the local immune microenvironment, (ii) halt chronic inflammation in the wound, iii) induce growth of new blood vessels, and iv) promote granulation tissue formation and skin re-epithelization – all in one product.
About Aurealis Therapeutics
Aurealis Therapeutics AG is a Swiss-Finnish clinical-stage company developing scalable and low COGS multi-target cell and gene therapies allowing to modulate tissue microenvironment and tackle complex multi-factorial diseases such as chronic wounds, cancers, and inflammation. Aurealis modular gene therapy platform consists of non-pathogenic lactic acid bacterium Lactococcus cremoris, genetically engineered to produce and release multiple human therapeutic proteins in the body: cytokines, chemokines, growth factors, antibody fragments. These living bacterium act as millions of nanoscale bioreactors at the site of the disease, allowing multi-targeting as one product, to treat multifactorial diseases. Aurealis pipeline includes Chronic Wounds (AUP-16, ongoing Phase 2), Oncology (AUP-55, pre-clinical stage), Inflammation (AUP-60, discovery stage).
For more information:
Laurent Décory, COO
Email: laurent@aurealistherapeutics.com
