Aurase® is a new enzymatic active ingredient developed by BRAIN for the biological treatment of open wounds. Blickwinkel interviewed Dr Bela Kelety and Dr Alexander Pelzer.
BRAIN: What is the special challenge involved in the treatment of open wounds?
Bela Kelety: Our skin acts as a barrier that protects us from pathogens. If this barrier is destroyed, there is a risk of contamination and infection that adds to the task of wound healing. Open wounds therefore require regular cleaning. To allow new tissue to grow, dead tissue has to be continually removed. This procedure is called debridement, and can be performed surgically under anaesthetic or as autolytic debridement. A third option is maggot therapy, in which fly maggots feed on the dead tissue. The choice of suitable debridement procedure depends on the type and size of the wound.
BRAIN: What was the starting point of your research into the Aurase® enzyme?
Alexander Pelzer: It is known that therapies using the maggots of the common green bottle or “golden” fly rely on the action of a number of enzymes. Enzymes are proteins (biocatalysts) that speed up biochemical reactions. Nature offers a rich collection of these biomolecules that are essential to life.
BRAIN: How do enzymes act in maggot therapy?
Alexander Pelzer: Maggots use the wound debris as a source of nutrients and export enzymes that break down a protein called fibrin, among others, which is one of the main constituents of the wound debris that impedes wound healing. Before we carried out our work, it was not known which enzyme plays a key role in this biological process. We knew that maggot therapies are very unpleasant for many patients. This knowledge spurred us on to decode the process involved.
BRAIN: What were the essential steps in this research?
Alexander Pelzer: We have managed to develop a gentle biological option for wound treatment that unites nature and biotechnology. First of all, we succeeded in identifying which enzyme breaks down fibrin without attacking the surrounding healthy tissue. We characterised this enzyme, which we later termed Aurase®, and then developed a biotechnological process to produce it in large volumes with a high degree of purity. The microorganism Pichia pastoris is the production organism here. This represents a safe expression system that is already being used widely in biotechnology.
BRAIN: How did people discover that the maggots of the common green bottle fly have medical properties?
Bela Kelety: It has been known since the Middle Ages that open wounds infected with maggots often heal better. Some even say that the Maya, the indigenous people of America, and the aborigines in Australia used maggots for wound care. The first scientific foundations were laid in the 1920s. This form of treatment fell into oblivion due to the development of antibiotics, and only regained popularity in the 1990s. Its current applications in hospitals are based on this ancient knowledge, and make use of specially bred sterile maggots.
BRAIN: What advantages does the Aurase® enzyme offer as compared with other enzymatic active substances?
Alexander Pelzer: The Aurase® developed by BRAIN is an enzyme derived from the serin protease family that can break down proteins or peptides. Aurase® acts very specifically on the protein fibrin. This is not always the case with other enzymes. Some wound treatment enzymes are obtained from pineapple plants or pathogens. Such enzymes act unspecifically and not only break down fibrin, but may also damage healthy tissue. They are therefore used in low concentrations or only applied for short periods of time. That makes nursing more time-consuming and / or lengthens the wound cleaning process.
BRAIN: What positive effects do you expect from the Aurase® products?
Bela Kelety: Our interest focuses on wound patients whom we would like to offer a well-tolerated, effective alternative to the sometimes very painful and unpleasant forms of therapy available at present. While both surgical debridement and maggot therapy are effective, they are also time-consuming and cost-intensive forms of treatment, which call for a specialised infrastructure and detailed medical knowledge. We hope the Aurase® products will reduce the need to train nursing staff and the overall healing outlay. Aurase® will be easy to use and fit smoothly into existing wound management processes at hospitals, nursing homes or nursing care at home.
BRAIN: What form will the final Aurase® products take?
Alexander Pelzer: Various forms are conceivable in theory. A wound gel containing Aurase® as an active ingredient has proved to be favourable, and has been shown to be effective and well-tolerated in pre-clinical trials.
BRAIN: Can we expect BRAIN to focus on pharmaceutical biotechnology as well in future?
Bela Kelety: Our focus is and remains industrial biotechnology. In this context, we concentrate on developing new enzymes, natural active ingredients and high-performance microorganisms. However, our expertise in these three areas also enables us to address a variety of tasks. Aurase® is a medical product, and this is admittedly an unusual market segment for BRAIN. But when we realised the benefits we could harness with our know-how for patients and nursing staff, we couldn’t just ignore it. Apart from that, this offers attractive market opportunities.
BRAIN: What are the next steps in realising Aurase® products?
Bela Kelety: On the one hand, we are presently working to optimise the yield of the biotechnological production system for the Aurase® enzyme. Parallel to this, we are taking steps to extend patent coverage. We are also in touch with experts to prepare clinical studies for our first Aurase® products and to obtain marketing authorisation.
BRAIN: When do you intend to launch Aurase® products on the market, and what business model will you use?
Bela Kelety: We will continue to drive development forward until we receive marketing authorisation and make the products available on the market. We intend to show that Aurase® products work under real-life nursing conditions and offer clear advantages for patients, nursing staff and doctors. We expect our first sales in few years, and are currently examining various options for business models to grow this business in future. Experts estimate the annual sales volume of the market that BRAIN can address for Aurase®-based products at more than EUR 100 million in Europe alone. We intend to take part in this development.
Dr Bela Kelety
Dr Bela Kelety studied Chemistry at the Technical University of Darmstadt und completed his doctoral studies at the Max Planck Institute for Biophysics in Frankfurt/Main. In 2010 Kelety joined BRAIN AG, where he currently acts as Unit Head New Business Development.
Dr Alexander Pelzer
Dr Alexander Pelzer studied biology at Düsselsorf Heinrich-Heine-University and completed his doctoral studies at the Institute of Molecular Enzyme Technology at Jülich Research Center. He has been working at BRAIN since 2014, where he currently is Project Manager and Platform Coordinator Tailor-made Biocatalysts.