Roche Advances Novel Antibiotic Targeting Superbug into Phase 3 Trials
Swiss pharmaceutical company Roche has announced plans to advance its experimental antibiotic, zosurabalpin, into Phase 3 clinical trials. Developed in collaboration with Harvard University, zosurabalpin targets Acinetobacter baumannii, a drug-resistant bacterium responsible for severe hospital-acquired infections. This development represents a significant step in addressing antimicrobial resistance (AMR).
Acinetobacter baumannii is classified as a “Priority 1: Critical” pathogen by the World Health Organization (WHO) and an “Urgent Threat” by the U.S. Centers for Disease Control and Prevention (CDC). It is known to cause serious infections such as pneumonia and sepsis, particularly in hospitalised patients. The bacterium’s resistance to existing antibiotics poses a significant challenge in clinical settings.
Zosurabalpin operates through a novel mechanism of action, inhibiting the transport of lipopolysaccharide (LPS) to the outer membrane of Gram-negative bacteria. This disruption compromises the integrity of the bacterial membrane, leading to cell death. Importantly, this pathway is distinct from those targeted by existing antibiotic classes, suggesting that A. baumannii may not have pre-existing resistance mechanisms against it.
“Drug-resistant Acinetobacter are present across the world and disproportionately impact patients who are in hospital, causing serious infections like pneumonia and sepsis,” Roche stated in a recent announcement. Reuters
The upcoming Phase 3 trial is expected to commence in late 2025 or early 2026, enrolling approximately 400 hospitalised patients with life-threatening invasive A. baumannii infections. Participants will receive either zosurabalpin or the current standard of care. Roche aims to achieve regulatory approval by the end of the decade.
This advancement underscores Roche’s commitment to combating AMR, a growing global health threat. The development of zosurabalpin, with its unique mechanism of action, holds promise in addressing infections caused by multidrug-resistant bacteria.
Sources:
- Reuters – Roche moves antibiotic against superbug into Phase 3 of testing
- Roche – Product Development Portfolio
- World Health Organization (WHO) – WHO publishes list of bacteria for which new antibiotics are urgently needed
- U.S. Centers for Disease Control and Prevention (CDC) – CRAB: An Urgent Public Health Threat
- CDC Overview on Acinetobacter Infections – About Acinetobacter
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