Carb-X Awards Debiopharm $12.3 Million for Gonorrhea Antibiotic Development

Debiopharm, a Swiss-based biopharmaceutical company, has recently received additional funding from CARB-X, a global non-profit organization that accelerates antibacterial research. This funding will support the clinical advancement of Debio 1453, an innovative antibiotic designed to combat Neisseria gonorrhoeae infections. The CARB-X grant, initially set at $7.9 million USD and now increased by $12.3 million USD, is divided into two stages. The first stage is dedicated to moving Debio 1453 into Phase I human trials, while the second stage depends on reaching specific developmental milestones. Overall, CARB-X's financial aid to Debiopharm is expected to exceed $20 million USD, facilitating the transition of Debio 1453 from preclinical to clinical use and aiming for a timely progression to Phase 2 trials.

Morgane Vanbiervliet, Debiopharm's Director of Global Development and Licensing, expressed satisfaction with CARB-X's ongoing support, highlighting the strong preclinical evidence for Debio 1453's effectiveness against gonorrhea. The company aims to establish a new standard for treating N. gonorrhoeae infections by offering an antibiotic with a unique mechanism of action, providing a crucial alternative against multi-drug-resistant strains.

Erin Duffy, R&D Chief of CARB-X, praised Debio 1453's novel approach to tackling antibiotic resistance. She emphasized the antibiotic's potential to offer a lasting solution for treating gonorrhea, a disease for which nearly all antibiotics have failed. Duffy expressed excitement about supporting the project's journey into human clinical trials, which is considered a critical step in providing new treatment options globally.

Debio 1453 works by inhibiting the FabI enzyme, essential for fatty acid synthesis in N. gonorrhoeae and a few other bacteria. This inhibition results in rapid bactericidal activity both in laboratory and real-world environments, presenting a promising solution for challenging gonorrhea infections.

The urgency for new treatments stems from N. gonorrhoeae's increasing resistance to current antibiotics, posing significant public health risks. Unaddressed, these infections can lead to severe health complications, including pelvic inflammatory disease, infertility, and heightened susceptibility to other infections. Gonorrhea can also be transmitted from mother to child during childbirth, potentially causing severe outcomes like sepsis or neonatal conjunctivitis, which can result in blindness if untreated.

In 2023, the United States reported 601,319 gonorrhea cases, ranking it as the second most common STI in the nation. Simultaneously, 28 EU/EEA countries reported 96,969 confirmed cases, marking a 31% increase from the previous year. The World Health Organization (WHO) and the United States Centers for Disease Control and Prevention (CDC) consider the development of new antibiotics against drug-resistant N. gonorrhoeae a high priority and an urgent health threat, respectively.

The research associated with this initiative is supported by CARB-X, funded in part by various governmental and philanthropic sources, including the U.S. Department of Health and Human Services, Wellcome Trust, Germany's Federal Ministry of Education and Research, the UK Department of Health, and the Novo Nordisk Foundation.

CARB-X is committed to supporting early-stage antibacterial research to combat the increasing threat of drug-resistant bacteria globally. The organization, led by Boston University, funds projects targeting the most severe and resistant bacteria. Debiopharm, for its part, strives to develop innovative therapies addressing unmet medical needs, focusing on oncology and bacterial infections. By bridging innovation and real-world application, Debiopharm aims to enhance patient access to groundbreaking treatments worldwide.