GARDP and Debiopharm Partner to Advance Development of Novel Gonorrhea Drug

The GARDP Foundation (known as GARDP) and the privately-owned, global biopharmaceutical company Debiopharm today announced that they have entered into a collaboration and license agreement to pursue the development of Debio1453, a novel, first-in-class antibiotic targeting Neisseria gonorrhoeae. With 82 million new cases each year, and the continued spread of multidrug-resistant N. gonorrhoeae strains, gonorrhea represents a global health crisis. This new partnership will help ensure that gonorrhea continues to be a treatable disease and will alleviate the risk of the emergence of future resistance, by ensuring that the antibiotic pipeline continues to be replenished.

Gonorrhea caused by N. gonorrhoeae is currently in danger of becoming untreatable because of antimicrobial resistance (AMR). Having developed resistance to almost all antibiotics used to treat it, only one last recommended treatment, ceftriaxone, remains effective, and now we are seeing a growing number of cases that are resistant to this. Even with the recent approval in late 2025 of two new first-in-class treatments for N. gonorrhoeae, there is growing concern that without ongoing development of innovative new treatments, like Debio1453, the rapid emergence of resistance will see this “super gonorrhea” outpace antibiotic development.

“As a private company aligning our efforts with a not-for-profit organization, we see this collaboration with GARDP as a pioneering public-private model to expand global access to this innovative new drug candidate. The confirmation of this partnership is a powerful indicator of Debio1453’s potential to replenish a critically depleted antibacterial pipeline, addressing a severe therapeutic gap,” said Morgane Vanbiervliet, Director, Global Development and Licensing, Debiopharm. “For those struggling with multidrug-resistant gonorrhea, this agreement signals a decisive step toward restoring effective treatment options and ensuring long-term antibiotic sustainability.”

With crucial funding from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), the development of Debio1453 successfully progressed from a preclinical candidate to a clinical stage asset. As part of this new collaboration and license agreement, Debiopharm remains in charge of the completion of the Debio1453 Phase I clinical trial, while GARDP will lead other non-clinical and clinical development activities, as well as chemistry, manufacturing and controls (CMC) activities. Both organizations aim to ensure that the global development and future access strategies of Debio1453 are aligned with country-specific regulatory requirements, health system realities and local economic constraints. Debiopharm has granted GARDP manufacturing and commercialization rights in relation to Debio1453 across more than 160 countries to ensure future global access.

“GARDP is committed to bringing new classes of antibiotics to market to tackle the rise and spread of AMR,” said Dr Manica Balasegaram, Executive Director of GARDP. “This new partnership demonstrates the flexibility of GARDP’s public-private partnership model. It is great to see a Swiss for-profit and a Swiss non-profit working together to develop an innovative new solution to address gonorrhea and explore opportunities in other areas.”

The novel drug candidate Debio1453 offers significant hope, demonstrating strong activity against multidrug-resistant strains by targeting the essential FabI enzyme for bacterial survival, with the added crucial advantage of showing no cross-resistance to currently available antibiotic classes.

Untreated gonorrhea can have a devastating impact on both men and women’s health, including infertility, ectopic pregnancy and pelvic inflammatory disease in women. It can also impact partners and increase HIV transmission risk. Babies born while a mother is infected with gonorrhea are at risk of severe eye infections that can result in blindness.

The high financial and social costs of these effects are compounded by rapidly spreading antimicrobial resistance in N. gonorrhoeae, which prolongs infections and increases the long-term health burden globally. Because resistance spreads quickly and surveillance is often lacking, especially in resource-limited settings, the actual level of treatment failure is likely far higher than current reports indicate. This trend threatens health systems worldwide, including those in high-income countries.¹

Debiopharm’s commitment to patients

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.

Visit us: www.debiopharm.com/drug-development/

Follow us: https://www.linkedin.com/company/debiopharminternational/

About GARDP

GARDP (the Global Antibiotic Research & Development Partnership) is 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. Vital support for our work comes from the governments of Canada, Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Commission, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. GARDP is registered under the legal name GARDP Foundation in Switzerland. www.gardp.org

Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is provided in part with 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), Germany’s Federal Ministry of Research, Technology and Space (BMFTR), the UK Department of Health and Social Care as part of the Global Antimicrobial Resistance Innovation Fund (GAMRIF) and the Novo Nordisk Foundation. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders.

References

1. World Health Organization. Multi-drug-resistant gonorrhoeae. 2025 Oct 22 (https://www.who.int/news-room/fact-sheets/detail/multi-drug-resistant-gonorrhoea)

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