Belgian biotech AMR breakthrough as WHO warns antibiotic pipeline is failing

Belgian biotech AMR breakthrough as WHO warns antibiotic pipeline is failing

Race for new antibiotics intensifies as WHO warns drug pipeline remains thin, and remains structurally unfit to support antibiotic innovation

[Getty Images: pongvit]

A Belgian biotech company says it is advancing a novel approach to one of the world’s most dangerous drug‑resistant pathogens, as the World Health Organization issues new target product profiles for urgently needed antibiotics.

Obulytix, a Belgian biotechnology firm, has announced it’s developing a new class of antibacterial therapies aimed at multidrug‑resistant Gram‑negative bacteria, including Acinetobacter baumannii – one of the organisms highlighted in the WHO’s updated guidance.

The profiles set out desired characteristics for antibiotic candidates designed to treat three critical categories of infection: severe multidrug‑resistant Gram‑negative infections; resistant Gram‑positive infections in immunocompromised or critically ill patients; and bacterial meningitis.

Particular attention is given to carbapenem‑resistant A. baumannii, Pseudomonas aeruginosa and resistant Enterobacterales, which are responsible for some of the gravest hospital-acquired infections, including bloodstream infections and ventilator‑associated pneumonia.

Despite roughly 90 antibacterial agents currently in global preclinical or clinical development, the WHO said that relatively few agents target these high‑priority pathogens and even fewer represent “genuinely innovative” mechanisms of action.

“The scientific community has developed and approved new antibiotics in recent years. This is good, but unfortunately not sufficient to catch up with evolving drug-resistant bacteria, especially against those of greatest concern,” said Dr Yvan Hutin, director of antimicrobial resistance at the WHO. “We need a reliable pipeline with new antibacterial agents that are innovative, affordable, and accessible to all those who need them.”

Targeting a top‑priority threat

Obulytix says its lead programme is focused squarely on one of the WHO’s most urgent concerns. “Obulytix’s lead programme directly targets multidrug-resistant Acinetobacter baumannii, one of the WHO’s highest-priority Gram-negative pathogens,” chief executive Kristof Van Emelen told Euractiv.

The company is engineering Precision Lysin Therapeutics (PLTs), enzymes derived from bacteriophages designed to degrade bacterial cell walls.

“Lysin-based therapeutics represent a genuinely new antibacterial class,” the company said. “Unlike traditional antibiotics, our PLTs enzymatically degrade the bacterial cell wall with rapid and irreversible killing.”

According to Obulytix, the approach could bypass “classical resistance mechanisms such as β-lactamases, porin loss or efflux pumps,” offering what it calls “a fundamentally different way of treating multidrug-resistant infections.”

Long‑standing scientific challenge

Gram‑negative bacteria have long posed one of the toughest frontiers in antimicrobial research. Their outer membrane acts as a barrier that prevents many drugs from entering the cell, contributing to decades of stagnation in novel antibiotic classes that can act against them.

Engineering lysins to penetrate this barrier has historically proven difficult, with many attempts failing to demonstrate consistent activity under physiological conditions.

Obulytix says its engineered lysins have shown bactericidal activity in high‑serum environments characteristic of severe infections such as septicaemia. The company reports activity against A. baumannii in laboratory studies, as well as reductions in bacterial burden in mouse models of bloodstream infection.

The company argues that the likelihood of resistance emerging against lysins is lower than with traditional antibiotics and that the molecules can be used either with existing therapies or independently.

“PLTs show synergy with standard-of-care antibiotics, enabling their use as adjunctive therapy to enhance efficacy and potentially extend the clinical life cycle of existing regimens,” the company said. “They also hold potential as a standalone therapy in severe Gram-negative bloodstream or pulmonary infections.”

Innovation collides with economic constraints

The scientific progress comes against the backdrop of a market that health agencies warn remains structurally unfit to support antibiotic innovation. Because new antibiotics must be used sparingly to preserve their effectiveness, companies face weak commercial incentives even when addressing major societal needs.

European policymakers are seeking to correct this imbalance through mechanisms such as transferable exclusivity vouchers and through reforms to EU pharmaceutical legislation. But developers say further measures will be required to bring first‑in‑class agents through late‑stage trials.

“There is still a significant gap between early scientific excellence and late-stage development support,” Obulytix said. “For companies developing first-in-class therapeutics against priority pathogens such as multidrug-resistant A. baumannii, predictable pull incentives and coordinated EU-wide subscription models will be essential.”

In a press statement, it warned that Europe remains “mid-transition” in building a viable economic environment for antibiotic innovation. “Scientific readiness is high; economic readiness still needs strengthening,” it said, adding that “an updated European framework is needed to have a truly sustainable impact.”

Belgium seeks to tighten domestic response

The global push for new antibiotics coincides with Belgium’s efforts to strengthen its national strategy on antimicrobial resistance. A draft plan for 2026-2030 proposes tying a portion of hospital financing to performance on infection prevention and antibiotic stewardship — a shift towards incentive‑based accountability.

Authorities are now reviewing submissions from the public consultation before finalising the strategy for political approval. If adopted, the plan would introduce new performance indicators, benchmarking and transparency tools intended to alter prescribing habits and bolster infection‑control practices, as Belgium works to meet EU‑aligned targets on antibiotic use.

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