Fedora Pharmaceuticals is presenting new preclinical data at the IMARI conference demonstrating that its lead candidate, FPI-2119, shows strong activity against some of the most dangerous drug-resistant Gram-negative infections, supporting its advancement toward clinical trials.
Fedora Pharmaceuticals a biotechnology company focused on combating antibiotic-resistant infections, announced that it is presenting 4 scientific posters at the inaugural Interdisciplinary Meeting on Antimicrobial Resistance and Innovation (IMARI). The presentations detailed the mechanism of action, preclinical efficacy, and resistance profile of FPI-2119, the company’s lead investigational antibiotic.
FPI-2119 is a first-in-class, non-β-lactam antibiotic derived from lactivicin, a compound first identified in the 1980s but never fully developed. The investigational antibiotic targets penicillin-binding proteins (PBPs), which are essential for bacterial cell wall construction and survival. By disrupting this process, FPI-2119 demonstrates potent activity against antimicrobial-resistant (AMR) Gram-negative pathogens, a group of bacteria responsible for some of the most difficult-to-treat infections worldwide.
Preclinical studies presented at IMARI showed that FPI-2119 produced dose-dependent reductions of Klebsiella pneumoniae in mouse models of bacteremia and lung infection. K pneumoniae is a leading cause of Gram-negative bloodstream infections and hospital-acquired infections, and treatment is increasingly complicated by high rates of antibiotic resistance. In vitro data further demonstrated that FPI-2119 is active against multidrug-resistant strains of K pneumoniae, as well as other resistant Gram-negative pathogens including Escherichia coli and Enterobacter cloacae.
Notably, FPI-2119 also showed strong potency against carbapenem-resistant organisms such as Pseudomonas aeruginosa and Acinetobacter baumannii. Carbapenems are often considered antibiotics of last resort, yet resistance to this class continues to rise. In laboratory testing, FPI-2119 exhibited 8- to 16-fold greater activity against these life-threatening pathogens compared with current therapeutic options.
FPI-2119 is a first-in-class, non-β-lactam antibiotic with strong preclinical activity against multidrug-resistant Gram-negative pathogens.
The candidate demonstrated notable potency against carbapenem-resistant bacteria, outperforming existing therapies in vitro.
The IMARI data support advancing FPI-2119 into clinical development amid the growing global threat of antimicrobial resistance.
“Mortality rates for invasive infections are increasing as drug-resistant strains spread,” Fedora Pharmaceuticals CEO Christopher Micetich, said in a statement. “The encouraging preclinical results we are presenting at IMARI support advancing FPI-2119 into clinical trials and highlight the potential of responsibly developed novel antibiotic classes.”
“Despite improved awareness of antimicrobial stewardship, resistance continues to rise, underscoring the urgent need for new antibiotics,” Karen Bush, PhD, professor Emerita at Indiana University and a member of Fedora’s scientific advisory board, said in a statement. Bush, who has spent more than three decades researching antibiotic resistance, also introduced the IMARI session on emerging antimicrobial agents with a presentation on the historical evolution of the antibiotic development pipeline.
Look for more commentary about this investigational antibiotic in a future interview.
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