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This extension of over $1 million will allow the completion of preliminary toxicology studies needed to determine the doses for pivotal toxicology research as well as optimize the production steps of the development candidate. This is a step towards the development of an affordable, quality product for human use and eventual clinical research. This funding succeeds the previous rounds over the last 4 years supporting earlier research, totaling up to $4 million since 2017. "CARB-X is taking a portfolio approach to tackling gonorrhea by investing across all pillars - preventatives, diagnostics, and therapeutics. New classes with oral options are much needed to treat gonorrhea; as such, we are pleased to support the progression of '1453 into preclinical studies," said Erin Duffy, PhD, Chief of R&D at CARB-X. Due to an alarming level of antimicrobial resistance and infection, N. gonorrhoeae represents a concerning global public health issue with a high unmet need for new treatments.1 In response to this urgent need, Debiopharm is developing Debio 1453, a novel narrow-spectrum antibiotic that inhibits FabI, an enzyme essential for fatty acid synthesis in this bacteria. A promising lead compound has emerged from previous development exhibiting strong efficacy in pre-clinical models. This compound has the potential to expand the range of treatments against N. gonorrhoeae and to be active against resistant strains. "We are thrilled and appreciative having been awarded an additional grant from CARB-X. This renewal of research funding demonstrates the promising capacity of our antibiotic program to make a revolutionary impact in the battle against drug-resistant N. gonorrhoeae," said Thierry Mauvernay, President of Debiopharm. Various formerly efficacious treatments have become ineffective attributable to N. gonorrhoeae's extensive history of microbial drug resistance.(1) According to the CDC, it is paramount to perpetually observe antibiotic resistance in N. gonorrhoeae as well as stimulate the research and development of new treatment practices.(2) The infection is transmitted to approximately 78 million people each year and can cause serious conditions such as pelvic inflammatory disease and in some cases, infertility in the absence of treatment.(3) "It is critical to act quickly in face of the skyrocketing amount of super-bugs indicating resistance to available antibiotics," said Bertrand Ducrey, CEO of Debiopharm. "In order for us to be equipped to evade an approaching epidemic of patients with N. gonorrhoeae vastly resistant to current therapies, we must continue to make strides in new treatment development." Research reported in this press release is supported by CARB-X. CARB-X's funding for this project is sponsored by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust. The content is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders. (continues)