Basel Switzerland, Kuopio Finland – April 26th 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 CEO Juha Yrjänheikki and CMO Dirk Weber will attend and discuss the company´s progress at the Swiss Biotech Day in Basel on May 3rd 2018.
The Swiss Biotech Day has long become the standard annual get-together of the Swiss biopharmaceutical industry. It includes company presentations, partnering, exhibition, lectures and General Assembly of Swiss Biotech Association.
“AUP-16 hits all the key points for the patients with chronic wounds – anti-inflammation, angiogenesis induction and granulation tissue promotion. For that reason, the leading wound care clinical opinion leaders support us and believe that this therapy can make a difference in this devastating disease” stated CMO Dirk Weber, MD, PhD.
“We are pleased to attend and update the investors, pharma and biotech community of our diabetic foot and vascular leg ulcer product AUP-16, which is scheduled to start our first-in-human study in patients this year. AUP-16 is the first ever three-in-one multitherapy option for chronic wound sufferers” said CEO Yrjänheikki.
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.