The European Food Safety Authority (EFSA) has published a positive scientific opinion on Proteon Pharmaceuticals' bacteriophage product, Bafasal.
Tackling salmonella in birds
A liquid feed additive comprising four bacteriophages, Bafasal is designed to prevent salmonella infections and associated productivity losses without disrupting the microbiome.
Reacting to the publication of the EFSA opinion, Proteon said the evaluation confirms the phage’s potential as a zootechnical additive in reducing Salmonella Enteritidis contamination in poultry production environments.
“This positive scientific assessment is a crucial milestone in our EU registration journey.
“The opinion will now serve as the foundation for discussions in the EU Commission and EU member states as part of the authorization process for feed additives in the EU.”
The Authority’s FEEDAP Panel concluded that Bafasal has the potential to be efficacious as a zootechnical additive in reducing environmental contamination with S. Enteritidis when used in water for drinking or liquid complementary feed for all poultry species.
No conclusions were drawn on the effects of the additive on other Salmonella serotypes.
Proteon initiated the EU approval process for Bafasal in 2017. The final decision on EU market authorization will be made by the Standing Committee on Plants, Animals, Food, and Feed (SCoPAFF).
EU application guidelines for phage products
EFSA has developed criteria for characterizing phages, drawing on its experience with Proteon’s applications. These criteria have been consolidated into a new guidance document currently open for public consultation until February 2025.
Last week saw a high-level debate in the EU Parliament that highlighted the potential of phage technology in tackling antimicrobial resistance (AMR) across multiple sectors.
Antibiotic-resistant bacteria are projected to cause more fatalities than cancer by 2050 and carry a $1.5 trillion economic impact.
At the Animal AgTech Innovation Summit in Amsterdam in October, Justyna Andrysiak, chief product and technology officer at Proteon, detailed her company’s pioneering research in bacteriophage applications over 15 years.
While bacteriophages have been known for more than a century, they were long overshadowed by antibiotics.
“What’s innovative in our approach,” Andrysiak explained, “is that today we have the tools to characterize and produce bacteriophages in a scalable, repeatable way.”
She highlighted the rapid progress in molecular biology and AI-driven genomic analysis, enabling Proteon to conduct in-house characterization of phages and tailor specific, synergistic cocktails to enhance product stability, specificity, and resistance resilience.
Proteon has built a comprehensive dataset on the safety and efficacy of phage products, including tolerance and mutagenicity data, she reported.
