New First-in-Class Clinical Candidate to Tackle Enterobacteriaceae Infections

Nosopharm, a company dedicated to the research and development of new anti-infective drugs, was selected to present its first-in-class clinical candidate, NOSO-502, at the New Agents Discovery Summary Session at ASM Microbe 2018.

NOSO-502 is the first clinical candidate of the novel antibiotic class called Odilhorhabdins (ODLs). It inhibits the bacterial ribosome with a new mechanism of action. NOSO-502 is intended primarily for the treatment of nosocomial infections caused by Enterobacteriaceae, including polymyxin- and carbapenem-resistant Enterobacteriaceae (CRE). No novel class of antibiotics against those pathogens has been introduced into clinics since the 1980s. Enterobacteriaceae are at the top of the WHO’s list of priority pathogens for the development of new antibiotics, classed as critical.

NOSO-502 has proven to be effective in vivo in several Enterobacteriaceae infection models, such as peritonitis/sepsis, urinary tract infection and respiratory tract infection. It has also demonstrated antibacterial activity in vitro against multi-drug resistant clinical isolates (KPC, NDM, and OXA among others). NOSO-502 therefore has significant potential for the treatment of serious nosocomial infections.

"We are honored to have been asked to present the promising results of our pre-clinical studies with our prime candidate, NOSO-502, at ASM Microbe. This selection highlights the fact that we are one of the very few biotech companies developing high potential first-in-class antibiotics and one of the most advanced to enter clinical trials,” said Philippe Villain-Guillot co-founder and chief executive officer of Nosopharm. “There is an urgent need to introduce a new class of antibiotics, especially to address life-threatening CRE infections. We are excited that our novel antimicrobial agent class, ODLs, could bring a much-needed revolution in the field of antimicrobial resistance.”

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“The infectious disease community is excited by the discovery and development of new antimicrobial agents to treat drug-resistant infections,” said Prof. Karen Bush, Antimicrobial Agents and Resistance (AAR) track leader of the steering committee of ASM Microbe 2018. “We are especially encouraged by reports of agents from novel classes not represented by our traditional antibiotics.”

Nosopharm expects IND-enabling studies to start in 2019 and to launch first-in-human studies with NOSO-502 in 2020.

Hospital pathogens with multiple antibiotic resistances are responsible for at least 380,000 infections and 25,000 directly related deaths in the European Union every year. The annual treatment and social costs have been estimated at some €1.5 billion ($1.59bn). From a global perspective, antimicrobial resistance could kill up to ten million people every year by 2050, which could cost up to €94 trillion ($100tn).