NosoPharm, an innovative company dedicated to the research and development of new anti-infective drugs, has announced the positive results of regulatory toxicology studies of NOSO-502, a first-class antibiotic drug candidate for the treatment of multidrug-resistant nosocomial infections. Nosopharm is developing NOSO-502 in partnership with GNA NOW, a European consortium funded by the Innovative Medicine Initiative 2 (IMI2).
NOSO-502 is the first clinical-stage candidate from the new class of Odilorhabdines antibiotics, from the bacterium Xenorhabdus discovered by Nosoform. NOSO-502 is intended for the treatment of major nosocomial infections caused by multi-resistant enterobacteriaceae: Escherichia coli, Klebsiella pneumoniae and Enterobacter spp.
NOSO-502 inhibits bacterial ribosomes through an innovative mechanism of action: it activates against carbapenem-resistant enterobacteriaceae with their carbapenemase production profile, including polymyxin-resistant isolates.
These pathogens are responsible for serious and potentially fatal nosocomial infections. The World Health Organization (WHO) classifies them as important priority pathogens for which new antibiotics are urgently needed. The results of the GLP (Good Laboratory Practice) toxicology study, combined with other results from the study of clinical microbiology, efficacy, and pharmacodynamic pharmacokinetics, make it possible to prepare an application for approval of clinical trials. If the latter is approved, NOSO-502 will be able to enter clinical trials in humans.
“The results of this GLP toxicology study are very encouraging. Combined with other findings from the GNA NOW consortium, they allow us to continue developing the program up to Phase 1 subject to regulatory approval. This is an important step for NosoPharm: the quality of these results is NOSO-502.” And demonstrates the innovative nature that can treat life-threatening multidrug-resistant infections, “said Philip Villain-Guillot, co-founder and CEO of Nosopharm. .
One of the top ten global public health threats announced by the WHO, antibiotic resistance – a silent epidemic – claimed 1.27 million lives in 2019. Multi-resistant Gram-negative pathogens are responsible for 59% of these deaths, and are widely considered the main culprits, the most dangerous for patients. Indeed, there is currently a lack of new agents capable of treating antibiotic resistance in Gram-negative bacteria, especially in compounds with a new mechanism of action. Finding and developing such compounds represents a huge scientific challenge, which requires the collaboration of actors with different skills.
Created in 2019, the GNA NOW (Gram-Negative Antibacterials Now) consortium, led by Evotec as a representative of the European Federation of Pharmaceutical Industries and Associations (EFPIA), seeks to advance this new class of antibiotic prevention targets. Gram-negative agents, from lead optimization to completion of Phase 1 clinical trials.
For more than 40 years, no new antibiotic clinic has been launched that works against these pathogens. In addition, according to a recent analysis of the antibacterial drug pipeline, there are no first-class Gram-negative antibiotics with fancy goals or modes of action in clinical development. If successful, the clinical use of NOSO-502 will provide physicians with a new option for treating patients with life-threatening bacterial infections, thus avoiding a therapeutic dead end. NOSO-502 may strengthen the therapeutic arsenal against Gram-negative infections.
Source and visual: Nosopharm