Basel Switzerland, Kuopio Finland – April 30th 2018.
Aurealis Pharma, a private biopharmaceutical company developing novel three-in-one combination biologics for chronic non-healing wounds, cancer and osteoarthritis announced today that CMO Dirk Weber will attend and discuss the company´s progress and clinical development plans for lead development product AUP-16 indicated for chronic wounds at the European Wound Management Association congress in Krakow, Poland on 9th – 11th May, 2018.
The EWMA annual meeting is Europe`s largest congress to present scientific and clinical data in wound healing and from development products studied for treatment of various chronic wounds. Aurealis is proud to have a scientific poster presented with an overview on the Aurealis technology and a summary of the available non-clinical study data for AUP-16, the lead development product candidate to progress into a first-in-human phase 1 clinical study in patients with chronic wounds (diabetic foot ulcer, vascular leg ulcer) during 2018.
“We are pleased to present for the first time our non-clinical study results from our lead candidate AUP-16 for treatment of chronic wounds. We look very much forward to update and discuss our clinical plans for the planned development in patients with chronic wounds with clinical experts in the field and with experienced investigators interested in potentially joining our currently prepared phase 1 study, which is scheduled to be initiated by the end of this year. AUP-16 is the first ever three-in-one multitherapy option for chronic wound sufferers and has shown promising in vivo data on wound healing in a diabetic wound mouse model” said CMO Dirk Weber, MD, PhD.
“AUP-16 hits all the key pathophysiological aspects for the patients with chronic wounds – anti-inflammation, angiogenesis induction and granulation tissue promotion. For that reason, the leading wound care scientific opinion leaders support us and believe that this therapy can make a difference in this devastating disease. It is a great opportunity to present our clinical approach and the non-clinical data we have collected for AUP-16 at this prestigious event in Krakow” stated CSO Thomas Wirth, PhD.
AUP-16 is the lead product from Aurealis Pharma “combination biologics in one product” technology platform. It is a genetically engineered Lactococcus lactis, a non-pathogenic, probiotic bacteria, expressing human basic fibroblast growth factor (FGF2, bFGF), interleukin-4 (IL-4) and macrophage colony stimulating factor (CSF-1, 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 diabetic foot ulcers, venous leg ulcers and pressure ulcers). In the wound AUP-16 acts as millions of bioreactors producing the therapeutic proteins, which are designed to i) halt chronic inflammation in the wound, ii) induce growth of new blood vessels, and iii) promote granulation tissue formation and skin re-epithelization – all in one product.
AUP-16 is at clinical trial application submission stage in Europe. It is produced and scaled-up at GMP level with low cost-of-goods, has passed GLP safety and toxicity studies, and is planned to enter phase 1 clinical trial in 2018. It has passed EU regulatory authority scientific advice and is showing superior efficacy in non-clinical efficacy studies in non-healing diabetic wounds.