Milestone Achievement for Consortium seeking Solutions against AMR

The European-funded GNA NOW Consortium and Nosopharm, a biotechnology company exploring unconventional sources of antibiotics with potential in the fight against antimicrobial resistance, have announced a milestone development following completion and positive results of toxicology studies for a first-in-class antibiotic for the treatment of multidrug-resistant infections.

NOSO-502, discovered by Nosopharm from a Xenorhabdus bacteria, is intended for the treatment of the main hospital-acquired infections caused by the multidrug-resistant Enterobacterales: Escherichia coli, Klebsiella pneumoniae and Enterobacter spp. Inhibiting the bacterial ribosome with a new mechanism of action, NOSO-502 was found to be active against the Carbapenem-Resistant Enterobacterales (CRE), regardless of the profile of carbapenemase production, including polymyxin-resistant isolates. As these have been classified by the World Health Organisation (WHO) as critical priority pathogens, the results of the GLP toxicology studies, combined with other results in clinical microbiology, efficacy and pharmacokinetics/pharmacodynamics studies, enable preparation of a Clinical Trial Authorisation application, which if granted would see the entry of this candidate into first-in-human clinical studies.

“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.

Established in 2019, 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 1 clinical trials.

Commenting on this milestone, Lynn Silver, an expert in antibacterial drug discovery and preclinical development, also a member of the general project review group for the Innovative Medicines Initiative (IMI) said: “The positive results of the NOSO-502 program 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.”

GNA NOW is a joint initiative of 11 partners from industry and academia, coordinated by Lygature, with the goal of developing novel antibacterial agents. The Consortium hopes to bring one of the three simultaneously developed compounds through completion of Phase I studies, with the aim of one compound reaching Investigational New Drug (IND) stage and/or up to two compounds reaching clinical development candidate stage, by 2024.

The project received funding from the IMI 2 Joint Undertaking (JU) under grant agreement No 853979. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and the EFPIA.

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