When the Swiss company files RBX2660 in the US later this year to reduce recurrences of Clostridioides difficile infection, it will be the first time any firm has tried to get a non-antibiotic product approved to address an infectious disease. Ferring president Per Falk tells Scrip about the 35-year journey to get to this stage and why standardization is key when it comes to microbiome-based therapy.

The promise of microbiome-based therapeutics to treat a variety of diseases has become a hot topic and the first to get to market will be targeting Clostridioides difficile infection. Ferring and its subsidiary Rebiotix are in pole position.

Competing with several other firms to bring the first microbiome-derived therapy to market, Seres says the magnitude of its Phase III efficacy compared to placebo may enough for registrational filing.

Preliminary efficacy findings from an ongoing pivotal study of Ferring's RBX2660 showed that the first-in-class microbiota-based therapy helped restore the gut microbiome and break the cycle of recurrence of C diff. infection.