Aurealis Therapeutics Phase 1 clinical study for non-healing Diabetic Foot Ulcers (DFUs) had its last patient last visit on March 20, 2023. We are incredibly happy to share while 83% of the patients receiving the lead therapeutic dose achieved complete healing, no healed ulcer has recurred after 12 months follow-up. This was the first clinical study of our lead candidate AUP-16 in patients with non-healing DFUs.
Study AP-W-CLI-2018-8 was the first clinical study of AUP-16 in humans – in non-healing Diabetic Foot Ulcer (DFU) patients. This was a Phase 1-2A clinical study to evaluate the safety, tolerability and efficacy of single and repeated doses of AUP-16 as a topic treatment for DFUs. This was a Phase 1 multicenter, open-label, non-randomized, uncontrolled dose-finding clinical 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).
This clinical study was successfully completed in June 2022. The results showed that 83% of the patients receiving the lead therapeutic dose achieved complete healing, while no Dose Limiting Toxicity, no systemic or local safety nor tolerability issues were identified.
We are now initiating a multi-country, randomized, placebo-controlled Phase 2 study in non-healing DFUs, which was successfully submitted in December 2022.
About AUP-16
AUP-16 is a genetically engineered Lactococcus lactis, a non-pathogenic bacterium, 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 DFU, venous leg ulcers and pressure ulcers). In the wound AUP-16 acts as millions of immune activating bioreactors producing the therapeutic proteins, which are designed to i) halt the chronic inflammation in the wound and promote M2 inflammatory switch, ii) induce the growth of new blood vessels, and iii) promote the granulation tissue formation and skin re-epithelization – all in one product.
About Aurealis Therapeutics
Aurealis Therapeutics AG is a Swiss-Finnish private clinical-stage synthetic biology company focusing on the development of lactic acid bacteria -based GMO cell and gene therapies. The company’s lead clinical asset is AUP-16, the first-in-class four-in-one cell and gene therapy drug for chronic wounds and other inflammatory degenerative diseases. The product is based on proprietary technology involving genetically engineered lactic acid bacteria acting as millions of small immune activating bioreactors in the human tissue and producing multiple human therapeutic proteins into target tissue to effectively and safely re-educate the distorted host immune microenvironment to proper state.
For more information:
Laurent Décory, COO
Email: laurent(at)aurealistherapeutics.com
