An important milestone has been reached for the GNA NOW Consortium with the completion of the GLP toxicology studies for the NOSO-502 program. The results allow for the further development of the program to Phase 1.
The department of Clinical Pharmacology is looking forward to starting their work on the program GNA Now, which has just marked a major milestone.
NOSO-502 is the first clinical candidate in the new class of antibiotics called Odilorhabdins and was discovered by Nosopharm from a Xenorhabdus bacteria. NOSO-502 is intended for the treatment of the main hospital-acquired infections caused by the multidrug-resistant Enterobacteriaceae: Escherichia coli, Klebsiella pneumoniae, and Enterobacter spp. NOSO-502 inhibits the bacterial ribosome with a new mechanism of action. It is active against the Carbapenem-Resistant Enterobacteriaceae (CRE), whatever their profile of carbapenemase production, including polymyxin-resistant isolates. These pathogens are responsible for severe and life-threatening hospital-acquired infections and the World Health Organization (WHO) classifies them as critical priority pathogens for which new antibiotics are urgently needed. The results of the GLP toxicology studies combined with other results in clinical microbiology, efficacy, and pharmacokinetics/pharmacodynamics studies enable the launch of the preparation of a Clinical Trial Authorization application, and, if granted, the entry of NOSO-502 in First-in-Human clinical studies.
“Our department is specialized in this kind of clinical studies,” says Markus Zeitlinger, Head of the Department of Clinical Pharmacology at the Medical University of Vienna, “and we are happy to contribute to this very important collaboration.” The department plays a crucial role in the design, performance and analysis of this First-in-Human clinical studies. At the labs in Vienna the pharmacokinetics of the development compound will be investigated. The clinical assessment will cover safety and tolerability, laboratory values, physical examination and electrocardiogram as well as PK analysis. All procedures will be done in full accordance with ICH-GCP and the Declaration of Helsinki.
“This kind of collaborative is getting more and more important – especially when it comes to issues like novel antibiotics. Bringing together expertise and knowledge from industry and academia is most efficient in the development of new treatments and drugs.” The Department of Clinical Pharmacology at the Medical University of Vienna has performed almost 1.000 drug studies in the past 25 years – from First-in-Man to special PK studies. “We are not only extremely well equipped and trained for this, we are also very interested in pushing the limits in this field of research.”
Find out more about the project on the official IHI-Link