Biotechnology company Nosopharm has reported positive toxicology results for its first-in-class antibiotic for the treatment of multidrug-resistant hospital-acquired infections.
The company’s NOSO-502 is the first clinical candidate in the new class of antibiotics called Odilorhabdins and is being developed alongside GNA NOW, a European Consortium funded by the Innovative Medicines Initiative 2 (IMI2).
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 Enterobacterales: Escherichia coli, Klebsiella pneumoniae and Enterobacter spp.
Now, Nosopharm has reported positive GLP toxicology studies combined with other results in clinical microbiology, efficacy and pharmacokinetics/pharmacodynamics studies. Nosopharm will now prepare a Clinical Trial Authorisation application, which if granted, will enable the entry of NOSO-502 into first-in-human clinical studies.
Multidrug-resistant Gram-negative pathogens accounted for 59% of an estimated 1.27 million deaths in 20191. Antimicrobial resistance (AMR) has been described as one of the main threats facing global health, with Gram-negative bacterial widely regarded as the main culprit representing the gravest danger to patients. Currently, the pipeline for therapies addressing AMR in Gram-negative bacteria is lacking.
The GNA NOW Consortium (Gram-Negative Antibacterials NOW), led by Evotec as a European Federation of Pharmaceutical Industries and Associations (EFPIA) representative, is focused on addressing this gap in the AMR space by progressing new classes of Gram-negative antibiotics from lead optimisation to the completion of Phase I clinical trials.
The NOSO-502 programme received a unanimous recommendation from the internal and external experts of the GNA NOW Consortium to start preparing for clinical trials. This is of particular importance as novel classes of antibiotics with efficacy against the WHO critical priority Gram-negative pathogens are very rare. No novel class of antibiotics with efficacy against these pathogens has been introduced into clinical use for more than 40 years.
Official comments
Commenting on this milestone, Lynn Silver, an expert in antibacterial drug discovery and preclinical development, and a member of the general project review group for IMI said: “The positive results of the NOSO-502 programme demonstrate the importance of discovery and development partnerships like the GNA NOW Consortium. It proves that this kind of work can be done collaboratively by partners from academia, industry and big pharma. Together, it is possible to achieve positive results during the notoriously challenging early stages of antibiotic development.”
“The results of these GLP toxicology studies are very encouraging. Combined with the other results acquired with the GNA NOW Consortium, they allow us to carry out further development of the program to Phase 1, provided we receive regulatory authorisation. This is an important milestone. These results demonstrate the quality and the innovativeness of NOSO-502, which has the potential to treat life-threatening multidrug-resistant infections,” said Philippe Villain-Guillot, co-founder and CEO of Nosopharm.
References
1: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext
