OUR PRODUCT PIPELINE
IS ORGANIZED AROUND THREE THERAPY AREAS:
1. CHRONIC WOUNDS
Lead product: AUP-16
Phase 1 clinical study in Diabetic Foot Ulcer (DFU) patients was completed with excellent results. We received approval for Phase 2 clinical study in DFUs in May 2023; patient recruitment was completed in August 2024; last patient completed treatment in October 2024. Clinical trials in Venous Ulcer and Pressure Ulcer will follow.
2. ONCOLOGY
Lead candidate: AUP-55
We have obtained pre-clinical results in ovarian cancer and other secondary peritoneal carcinomatosis. Our first abstract was accepted and published at ASCO website.
3. INFLAMMATION
Lead candidate: AUP-60
At the discovery stage.
| Modality | Product | Discovery | In vivo POC | GLP, S&T, CMC | IND/CTA | Phase 1 | Phase 2 | Phase 3 | NDA/MAA |
|---|
THE PROBLEM
No effective treatment that can hit multiple targets as one product.
We believe that when treating complex diseases like chronic inflammation and cancer, one needs to hit multiple targets to be disease-modifying. Very few companies or products can claim to truly target multiple biological targets. With our 4-in-1 technology, we can.
The wound healing process, for example, involves multiple steps: inflammation, proliferation, angiogenesis, and epithelialization. This process occurs naturally in normal circumstances. However, in chronic non-healing wounds, this process is impaired — wounds remain in the inflammation stage. To successfully restart wound healing in chronic non-healing wounds, it is essential to activate different biologic targets.
AUREALIS THERAPEUTICS 4-IN-1 PRODUCT AUP-16
Even though many different treatments exist today – traditional or moist wound dressings, negative pressure wound therapy, cell and tissue-based products, skin substitutes, and growth factors – most existing products only tackle one target with a single mode of action.
That is why we created Aurealis Therapeutics 4-in-1 platform.
OUR SOLUTION: AUREALIS THERAPEUTICS 4-IN-1 PLATFORM
A synthetic biology, cell and gene therapy platform based on modified food-grade lactic acid bacteria. These bacteria are genetically modified to include 90 copies of a plasmid, allowing them to synthesize multiple human therapeutic proteins, acting as millions of bioreactors in the body.
We are the only company in the world to have genetically engineered bacteria expressing three human therapeutic proteins.
This novel cell and gene therapy platform is backed by pre-clinical and clinical results in wide-ranging applications from diabetic foot ulcers, other non-healing wounds, oncology and inflammatory diseases.
A synthetic biology, cell and gene therapy platform based on modified food-grade lactic acid bacteria. These bacteria are genetically modified to include 90 copies of a plasmid, allowing them to synthesize multiple human therapeutic proteins, acting as millions of bioreactors in the body.
We are the only company in the world to have genetically engineered bacteria expressing three human therapeutic proteins.
This novel cell and gene therapy platform is backed by pre-clinical and clinical results in wide-ranging applications from diabetic foot ulcers, other non-healing wounds, oncology and inflammatory diseases.
LEARN MORE ABOUT:
PUBLICATIONS
Aurealis Therapeutics had an abstract published and an e-poster presented at the European Wound Management Association (EWMA) Conference Barcelona 2025 titled: A randomized controlled Phase 2 trial to evaluate multi-factorial gene therapy AUP1602-C in the management of non-healing Diabetic Foot Ulcer. Access the abstract here and the e-poster here.
Aurealis Therapeutics published a scientific article in the Therapeutic Advances in Endocrinology and Metabolism peer-reviewed journal titled: Multi-target gene therapy AUP1602-C to improve healing and quality of life for diabetic foot ulcer patients: a phase I, open-label, dose-finding study. Access the scientific article here.
Aurealis Therapeutics presented an abstract and a poster at ISPOR Health Economic Conference titled: A Markov model to determine the cost-effectiveness of a multi-targeting bacterial gene therapy (AUP-16) at healing a Diabetic Foot Ulcer when compared to the current standard of care. Access the poster and the abstract here.
Aurealis Therapeutics presented a poster at the 14th International Symposium on Lactic Acid Bacteria titled: Multi-target bacterial gene therapy for chronic wounds and cancer. Access the poster here.
Aurealis Therapeutics’ abstract titled Effect of multi-targeting bacterial gene therapy on tumour regression and survival in mouse models of ovarian and intraperitoneal cancer was accepted for publication at the Journal of Clinical Oncology, an American Society of Clinical Oncology (ASCO) Journal.
Access the abstract here.
Aurealis Therapeutics gave an oral presentation at the European Wound Management Association (EWMA) Conference Milan 2023 titled: 4-in-1 live biotherapeutic Gene Therapy Medicinal Product (GTMP) accelerates healing of Diabetic Foot Ulcers (DFUs): a first-in-human, phase 1 clinical study. Access the oral presentation here.
Aurealis Therapeutics published a scientific article in the PLOS-One journal titled: 4-in-1 Combination therapy using Lactococcus lactis expressing three therapeutic proteins for the treatment of chronic non-healing wounds. Access the article here.
Aurealis Therapeutics presented a poster at the European Wound Management Association (EWMA) Conference Krakow 2018 titled: Therapeutic use of Lactococcus lactis bacteria to produce proteins locally in diseased tissues of chronic wounds. Access the oral presentation here.