Clinical development of two antimicrobial agents funded by Else Kröner-Fresenius Foundation
Bioreactors for the production of corallopyronin A in the biotech centre of the Helmholtz Centre for Infection Research (HZI) in Braunschweig.
The Else Kröner-Fresenius Foundation's ForTra gGmbH for Research Transfer—the largest medicine-funding foundation in Germany—supports the legally compliant production of new drug candidates for direct use in first-in-human clinical trials. Five projects—including two antimicrobial drug discovery projects of the German Center for Infection Research (DZIF)—are now being funded with a total of three million euros.
On the way to clinical application, a potential drug must overcome high and cost-intensive hurdles. To enable individual innovative projects that address an important medical need to carry out the legally required clinical trials, the Else Kröner-Fresenius Foundation's ForTra gGmbH für Forschungstransfer (ForTra) supports the expensive and time-consuming production of the necessary study material under GMP conditions. Financial support is provided for the entire production process or individual parts thereof for various classes of active agents. Of the total of 34 applications submitted by researchers at scientific research institutions, five projects—including two from the DZIF—were successful.
Production of Corallopyronin A clinical trial samples
Corallopyronin A is an antibiotic derived from marine soil bacteria by biotechnological means. The spectrum of activity of the antibiotic, which was developed under the leadership of Prof. Dr Achim Hörauf at the University Hospital Bonn, Prof. Dr Karl Wagner at the University of Bonn and Prof. Dr Marc Stadler at the Helmholtz Centre for Infection Research in Braunschweig, includes tropical worm diseases and multi-resistant bacteria. For corallopyronin A to be effective as a capsule, it needs to be embedded in edible polymers that improve solubility. Clinical trials require certified manufacturing, which is now made possible by the ForTra grant.
"For a project as large as the development of an antibiotic, there has to be collaboration between different funding agencies, as the financial volumes required are usually beyond the capacity of individual funders. We are very pleased that ForTra gGmbH, with its programmatic orientation, is filling a gap in this funding call and enabling us to proceed with the project," emphasises Prof. Hörauf.
ForTra funding enables the certified production of the corallopyronin A formulation: to activate the active agent, corallopyronin A is embedded in polymers via a spray process, and the resulting fine powder is granulated and filled into capsules.
Nasal application of Staphylococcus lugdunensis for eradication of Staphylococcus aureus—first microbiome intervention study in humans
To prevent serious infections caused by methicillin-resistant Staphylococcus aureus (MRSA) pathogens, a research team at the University of Tübingen led by Prof. Dr Andreas Peschel developed a probiotic bacterial strain that displaces MRSA from the nose, the natural MRSA habitat. In collaboration with Dr Meral Esen's team, the Staphylococcus lugdunensis-named bacteria have been prepared for GMP-compliant production and, under her leadership, will be tested for their efficacy in a first clinical trial on volunteers to prevent dangerous infections in high-risk patients in the future.
Can Staphylococcus lugdunensis protect at-risk patients from dangerous infections caused by Staphylococcus areus in the future? The ForTra funding allows to answer this question faster than planned.
"This is a new innovative approach with the hope of avoiding many MRSA infections in the future and reducing the use of antibiotics of last resort," explains Prof. Peschel.
"In GMP-compliant production of live bacteria, many factors—including time and financial considerations—have to be taken into account," adds Dr Esen. "We are very happy about the support of the Else Kröner-Fresenius Foundation, which now enables us to reach our goal—the first clinical trial in humans—much faster."
ForTra gGmbH for Research Transfer of the Else Kröner-Fresenius-Foundation
ForTra is a non-profit subsidiary of the Else Kröner-Fresenius Foundation. The purpose of the company is to promote medical science and research and to advance public health by transferring medical research results into clinical application for the benefit of patients and public health care.
The non-profit Else Kröner-Fresenius Foundation is dedicated to promoting medical research and supporting humanitarian projects. To date, it has funded around 2,400 projects. With an annual funding volume of currently more than 60 million euros, it is the largest foundation in Germany that promotes medicine. For further information, please visit: www.ekfs.de/en
Source: Press release of the Else Kröner-Fresenius-Stiftung
