Rebiotix and Ferring Pharmaceuticals have unveiled positive preliminary findings from an ongoing pivotal late-stage trial of the investigational microbiome-based treatment RBX2660, which is being developed to reduce C. diff infection recurrences.

According to the firms, the clinical development programme for RBX2660 is ‘the most advanced in the world’ in evaluating the safety and efficacy of a standardised, non-antibiotic microbiome-based therapy.

They note that antibiotics, the current standard of care, have been shown to disrupt the microbiome and increase the risk of C. diff recurrence, highlighting the need for alternative treatment options.

C. diff causes nearly 30,000 deaths a year in the US, while in Europe, the number of cases is increasing, with recurrent bouts of infection representing 10%-15% of all healthcare-related infections in hospitals annually.

‘As a live biotherapeutic, aiming to help restore the gut microbiome community, RBX2660 may bring an innovative therapeutic option to patients suffering from this potentially deadly infection,’ the companies note in a press release.

“C. diff infection is a significant public health threat that has limited treatment options. These positive preliminary findings represent a major step forward towards bringing an innovative, non-antibiotic option to patients that may help restore their gut microbiome,” said Per Falk, Ferring’s president and chief science officer.

“With health systems under increasing pressure due to viruses like COVID-19 and the rising threat of antimicrobial resistance, the need for new therapies is greater than ever. We believe the power of the microbiome has great potential and we look forward to bringing RBX2660 to patients soon.”

The ongoing Phase III trial is a randomized, multicenter, double-blinded, placebo-controlled study, from which a full data package is anticipated in the second half of 2020.