Aurealis Therapeutics, a synthetic biology company developing ground-breaking four-in-one cell and gene therapies, announced today the publication of the first study on its investigational product AUP-16, a four-in-one -combination therapy using live Lactococcus lactis expressing three human therapeutic proteins for the treatment of chronic non-healing wounds. This announcement comes as the company successfully completed an exclusive license and collaboration agreement with XBiome for the clinical development and commercialization of AUP-16 for Diabetic Foot Ulcer (DFU), other chronic wounds, and inflammatory diseases in Greater China.
“Diabetic ulcers are the leading cause of non-traumatic lower limb amputations, and dramatically increase patient mortality. Despite a huge unmet need, no pharmacological wound healing product has been approved for more than 10 years,” said Thomas Wirth, CSO of Aurealis Therapeutics. “We believe AUP-16 can be a game changer, and we are really happy to have this study published on reputable peer-reviewed journal such as PLOS ONE.”
Dr. Jere Kurkipuro, lead author of the study and Head of Non-Clinical Pharmacology at Aurealis Therapeutics said “Many DFU patients do not respond to standard treatments, and there is a lack of evidence for many of the advanced therapeutic approaches. AUP-16 is designed as a single pharmaceutical entity, based on non-pathogenic bacterium genetically engineered to address all aspects of wound healing. We’re really proud to see that this study shows how the combination of the individual components on the wound microenvironment initiates and improves healing in chronic wounds.”
The article is available on PLOS ONE website at the following address:
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.
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Laurent Décory, COO