Swiss-based Non-profit GARDP Supports the Development of Debiopharm’s New Potential Treatment for Gonorrhoea

The Global Antibiotic Research & Development Partnership (GARDP) and the Swiss-based global biopharmaceutical company Debiopharm have signed a memorandum of understanding to develop Debio 1453, a novel compound representing a new antibiotic class that targets Neisseria gonorrhoeae. Multidrug-resistant strains of N. gonorrhoeae have emerged globally, limiting treatment options and elevating this pathogen to the high-priority category on the World Health Organization’s Bacterial Priority Pathogen List. Such pathogens present distinct public health challenges that urgently require new treatments.

“Antibiotic-resistant gonorrhoea represents a serious threat to sexual and reproductive health,” said Morgane Vanbiervliet, Manager of Market Intelligence & Business Development, Infectious Diseases, Debiopharm. “Debio 1453 shows encouraging pre-clinical efficacy against resistant strains of N. gonorrhoeae. We are eager to continue to develop this compound in collaboration with GARDP.”

Debiopharm has completed the preclinical development of Debio 1453 with ongoing support from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). The MOU between Debiopharm and GARDP now sets the stage for a new partnership to develop the compound for regulatory approval and help make the final product available and affordable to treat patients worldwide.

“We are very pleased to lay the groundwork for a future partnership with Debiopharm,” said Yann Ferrisse, Director of Business Development at GARDP. “In line with our 2024-2028 strategy, we will continue to identify new opportunities like Debio 1453 to develop and make available treatments for gonorrhoea and other public health threats.”

Innovative approaches are necessary to treat N. gonorrhoeae, which has gradually developed resistance to many classes of antibiotics used to treat gonorrhoea infections. A single muscular injection of ceftriaxone is now the last available recommended treatment globally. Recent reports of outbreaks of ceftriaxone-resistant “super gonorrhoea” have heightened the urgency for new antibiotic treatments.

Debio 1453 shows promising activity against ceftriaxone-resistant and other multidrug-resistant strains of N. gonorrhoeae. The compound uses a unique and novel mechanism of action to target the FabI enzyme, on which N. gonorrhoeae relies for its growth and survival. In studies thus far, no cross-resistance to any antibiotic class has been observed.

With more than 82 million new gonorrhoea infections occurring globally each year, gonorrhoea is the third most common sexually transmitted infection. It can cause serious, lifelong consequences in men and women, and can amplify the spread of HIV in high-prevalence settings. When left untreated in women, gonorrhoea can lead to pelvic inflammatory disease that elevates the risk of complications in pregnancy, including the likelihood of ectopic pregnancies and infertility. Gonorrhoea can also be transmitted during birth to babies, who in turn can have health problems like gonococcal conjunctivitis.

Debiopharm

Debiopharm aims to develop innovative therapies that target high unmet medical needs primarily in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then hand stewardship to large pharmaceutical commercialization partners to maximize patient access globally.

For more information, please visit www.debiopharm.com

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GARDP

We are a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them. We receive vital support from the governments of Canada, Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as the Bill & Melinda Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. We are GARDP, the Global Antibiotic Research & Development Partnership. www.gardp.org

*CARB-X is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. Research reported in this press release is supported by CARB-X. CARB-X funding for this research is supported by federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number: 75A50122C00028, and by awards from Wellcome (WT224842), and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views CARB-X or its funders.

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