A high-level debate in the EU Parliament this week highlighted the potential of bacteriophages in tackling antimicrobial resistance (AMR).
The discussions illustrated the role those additives could play across multiple sectors. There was a particular focus on Bafasal, a salmonella-targeting phage product for poultry production.
Professor Jarosław Dastych, CEO of Proteon Pharmaceuticals, updated delegates on the EU regulatory status of that product, a liquid feed additive comprising four bacteriophages.
It is designed to prevent salmonella infections and associated productivity losses without disrupting the microbiome.
“Bafasal is at a quite advanced stage of registration in the EU,” he reported.
Regulatory journey
Proteon initiated the EU approval process for Bafasal in 2017 by submitting a dossier to the European Food Safety Authority (EFSA) to evaluate the additive’s safety and efficacy.
“In March 2021, EFSA issued a positive scientific opinion on the product’s safety but found the data on efficacy inconclusive,” said Professor Dastych.
Additional studies and data were provided, resulting in a second EFSA opinion in 2023.
That opinion acknowledged the product’s potential to reduce salmonella levels and emissions but raised concerns about its host range, specifically whether its efficacy was limited to a single strain of salmonella.
Proteon, he said, addressed these concerns with extensive organ studies and complementary evidence.
A third EFSA opinion, focusing on the host range issue, has been adopted but remains under embargo, according to Rosella Brozzi, scientific officer at EFSA’s FEEDCO unit.
From a scientific perspective, Professor Dastych is hopeful that the registration process is essentially complete.
The final decision will be made by the Standing Committee on Plants, Animals, Food, and Feed (SCoPAFF).
Broader implications for phage regulation
The debate also highlighted advancements in regulatory guidelines for phage products.
Brozzi reported that 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.
Tackling AMR with phages
The event, hosted by Tiemo Wölken, MEP from the S&D Group, brought together stakeholders from the phage research community, regulatory bodies, and EU agencies, including EFSA and the European Medicines Agency (EMA).
Speakers discussed the applications of bacteriophages in human health, veterinary medicine, and food safety. While emphasizing their potential to combat AMR, regulators called for more well-designed randomized clinical trials to strengthen the efficacy data for phage-based products in human health.
Additionally, the EMA was urged to provide further scientific advice and guidance to support the development of phage products.
