Immune System
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Production of Corallopyronin A clinical trial material – delivery of a formulated IMP

Institution: Institut für Medizinische Mikrobiologie, Immunologie und Parasitologie, Universitätsklinikum Bonn
Applicant: Prof. Dr. Achim Hoerauf
Funding line:
Translational Research
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To activate the active ingredient, corallopyronin A is embedded in polymers using a spraying process. The resulting fine powder is granulated and filled into capsules.
(© Prof. Dr. Karl Wagner (Institut für Pharmazeutische Technologie und Biopharmazie, Universität Bonn))

Project partner:

Prof. Dr. Karl Wagner (Institut für Pharmazeutische Technologie und Biopharmazie, Rheinische Friedrich-Wilhelms-Universität Bonn)
Prof. Dr. Marc Stadler (Abteilung für mikrobielle Wirkstoffe, Helmholtz-Zentrum für Infektionsforschung, Braunschweig)
 

Project:

In tropical and subtropical regions around 72 million people worldwide suffer from filariasis. River blindness or lymphatic filariasis are caused by worms transmitted by mosquitoes. To fight filariasis, scientists from Bonn and Braunschweig are investigating the natural compound corallopyronin A (CorA), an antibiotic that inhibits the bacterial RNA polymerase of bacteria, including the essential Wolbachia endosymbionts of worms. Killing of Wolbachia results in the death of the worms as well. In addition, CorA is active against several other bacteria and could also be used to treat chlamydial and gonococcal infections as well as multi-resistant Staphylococcus aureus infections. Thus, CorA is an antibiotic candidate with several Global Health targets in the WHO Priority Pathogen List that prioritizes the targets of urgently required new antibiotics.
 
The consortium, led by Prof. Achim Hoerauf, is developing CorA with the aim of obtaining product approval in one or more of the indications mentioned above. For this purpose, a clinical phase I study must be carried out to show safety in humans. For this purpose, the working group of Prof. Karl Wagner has developed oral formulations that have a higher oral bioavailability and stability compared to the raw substance. For CorA to be effective as a capsule, it needs to be embedded into water soluble polymers that enhance CorA solubility. CorA is currently being produced as  research-grade material with a purity of 90-95%, with a fermentation and down-stream process that was established in the lab of Prof. Marc Stadler.The team has engaged a contract manufacturing organization to produce the CorA drug substance under Good Manufacturing Practice (GMP) conditions that will be used to conduct the preclinical GLP studies and to obtain substance for the manufacture of the investigational medicinal product (capsules) for the clinical phase I trial. The funding from ForTra enables the group to produce the capsules for clinical testing according to GMP guidelines.

Here you can find further information and through this website.

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Prof. Dr. med. Achim Hoerauf, Director of the Institute for Medical Microbiology, Immunology and Parasitology at Bonn University Hospital
(© Prof. Dr. med. Achim Hoerauf (Institut für Medizinische Mikrobiologie, Immunologie und Parasitologie, Universitätsklinikum Bonn))