Clinical development of drugs for antibiotic resistance begins
This is particularly evident in immunocompromised or pre-existing patients, highlighting the need to develop innovative therapeutic strategies. In this context, antibody-based therapeutics offer a promising alternative to conventional antibiotics, as they specifically target bacterial disease mechanisms without damaging the healthy microbiome. They are highly specific, remain in the bloodstream for a long time, and are generally well tolerated. These properties make them particularly suitable for both acute therapy and preventive use in high-risk patients.
“In the long term, this approach opens up the possibility of using antibodies not only therapeutically but also prophylactically, for example to prevent nosocomial infections in particularly vulnerable patient groups,” explains Dr. Alexander Simonis, former Career Advancement Program Awardee and researcher at the Center for Molecular Medicine Cologne (CMMC).
Pseudomonas aeruginosa is a significant pathogen with widespread antibiotic resistance. The bacterium is particularly responsible for difficult-to-treat pneumonia in hospital patients. In addition, the pathogen can cause long-lasting infections in chronic lung diseases such as cystic fibrosis, which significantly impair lung function and quality of life. To effectively address this medical challenge, an innovative therapeutic approach to combating P. aeruginosa is now entering its next phase: Following the successful preclinical development of an antibody that specifically neutralizes the pathogen's disease-causing type III secretion system (T3SS), the project team led by Prof. Dr. Dr. Jan Rybniker and Dr. Alexander Simonis, focusing on clinical infectiology at Clinic I for Internal Medicine at Cologne University Hospital, is currently preparing for its GMP-compliant (Good Manufacturing Practice) production.
“The clinical development of new drugs, i.e., the transfer of scientific discoveries to patient application, is extremely expensive and time-consuming. These funds bring us a giant step forward,” emphasizes Prof. Rybniker, principle investigator at the Center for Molecular Medicine Cologne (CMMC).
The total funding for the project now amounts to over €3.2 million. In addition to ongoing support from the German Center for Infection Research (DZIF) in the amount of €1.7 million, the Else Kröner-Fresenius-Stiftung (EKFS) is now providing a further €1.55 million. The EKFS subsidiary ForTra gGmbH für Forschungstransfer is contributing €1.2 million to finance the GMP-compliant production of the antibody candidate. In addition, the EKFS is providing €350,000 in funding through its “Translatorik” funding line to prepare for a subsequent Phase I study for the first clinical trial in humans. Thanks to the targeted support of the Else Kröner-Fresenius-Stiftung, the upcoming translational steps can now be taken, significantly advancing the project. The upcoming production of the antibody under GMP conditions represents a decisive milestone, as it paves the way for clinical application and opens up new perspectives in the fight against this highly relevant pathogen.
Who are Jan Rybniker and Alexander Simonis? - Learn more about their research activities.
This message has been modified by the CMMC (K. Heber & D. Grosskopf-Kroiher) and is based on the text by the press and communications team of the University Hospital Cologne (original German version here).