Authors: Heather Jones, Future Science Group
Rebiotix (MN, USA) and Ferring (Saint-Prex, Switzerland) recently announced positive preliminary results from an ongoing clinical trial testing RBX2660, a non-antibiotic, microbiome-based therapy, which has been developed to reduce C. diff infection recurrences. The trial builds on nearly a decade of research and evaluation of the formulation, and further results are expected to provide insight into the potential of using microbes as a therapeutic intervention.
The search for treatments that reduce repeated C. diff infection is an urgent unmet need for patients and healthcare providers worldwide. The bacterium causes approximately 30,000 deaths each year in the US, while Europe is seeing a rise in the incidence of infection.
Antibiotics, the current standard of care, have been shown to disrupt the microbiome and increase the risk of C. diff infection recurrence.
“It is estimated that approximately 25% of patients who are treated with antimicrobials for C. difficile infection will recur, commented Paul Feuerstadt (Gastroenterology Center of Connecticut, USA). “Of those who recur, 40–50% will go on to recur after that resulting in a challenging cycle that some antimicrobial therapies have limited ability to break.”
In an attempt to break this problematic cycle, Rebiotix, a biotechnology company that forms part of the Ferring Pharmaceuticals Group, initiated a multicenter Phase III clinical trial, termed PUNCH CD3, earlier this year investigating the safety and efficacy of RBX2660 in treating C. diff infections.
This novel formulation is an investigational live biotherapeutic aiming to help restore the gut microbiome community.
The clinical development program for RBX2660 is said to be the most advanced in the world in evaluating the safety and efficacy of a standardized, non-antibiotic microbiome-based therapy. The company announced positive preliminary results from the trial last month, having met its primary efficacy endpoint.
Commenting on the significance of these results, Feuerstadt stated that “there has been a lot of data considering FMT and prevention of recurrence, but this is the first standardized form of fecal microbiota transplantation that has completed the rigors of a Phase III prospective clinical trial showing a positive effect on reducing recurrence.”
In order to monitor safety, the researchers will be following patients for several months after receiving the drug. The safety data will provide insight into the potential of using microbes as a therapeutic intervention, with the full data package anticipated in the second half of 2020.
“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,” commented Per Falk (Ferring). “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.”