Aurealis Therapeutics, a synthetic biology company developing ground-breaking four-in-one cell and gene therapies, announced today that it has successfully completed its Phase 1 study of its lead therapeutic candidate AUP-16 in non-healing Diabetic Foot Ulcers patients, both in terms of patient recruitment and treatment. While patient observation period continues, collected data will be processed and consolidated for publication. The primary endpoint of this dose escalation study was to evidence the safety and tolerability of the product and to determine the recommended therapeutic dose for our coming Phase 2 study. The secondary endpoint of the study was the efficacy of the product, both in terms of wound size reduction and complete wound closure.
“AUP-16 demonstrated an excellent safety profile and very promising efficacy during this Phase 1 study, with no Dose Limiting Toxicity, or Systemic Toxicities, and no Serious Adverse Reactions. We are extremely delighted about the efficacy data, as 83% of the patients receiving the lead therapeutic dose reached complete healing” said Dr Haritha Samaranayake, CMO for Aurealis Therapeutics.
“Aurealis team has been extremely supportive, despite challenges related to COVID-19 pandemic. We have seen patients respond to AUP-16, even at low dose, and the healing rate observed for the high dose patient group is impressive” declared Dr Jacek Mikosiński, Vascular Surgeon, Principal Investigator of the study.
“We want to express our gratitude to the whole team, internal and external, for completing the trial so professionally and diligently during the challenging COVID-19 era. We are extremely happy about the study results, and we’re looking forward to consolidating these data during our Phase 2. DFU and other non-healing wounds are a massive unmet medical need and market opportunity. The patients, families and caregivers deserve new, curative treatment options” continued CEO Juha Yrjänheikki.
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