Ferring Pharmaceuticals and Rebiotix have presented Phase III results demonstrating superior efficacy of investigational RBX2660 in reducing recurrence of Clostridioides difficile (C. difficile) infection.
RBX2660 successfully met the primary endpoint in the Phase III trial in data presented at Digestive Disease Week.
RBX2660 is an investigational, potential first-in-class microbiota-based live biotherapeutic. The treatment demonstrated superior efficacy versus placebo (70.4% and 58.1%, respectively) at eight weeks post treatment, with a comparable safety profile to placebo.
RBX2660 results demonstrated statistical significance with a 98.6% posterior probability of superiority, which exceeded the 97.5% minimum threshold.
In addition to these outcomes, RBX2660 provided a relative reduction of recurrence of 29.4% compared to placebo.
Paul Feuerstadt, MD, and RBX2660 clinical trial investigator said: “C. difficile infection is a global public health threat that requires immediate action to halt the unrelenting cycle of recurrence. While necessary to treat initial infection, antibiotics are also a predominant risk factor for recurrence because they can disrupt the gut microbiome, leaving the current treatment paradigm for recurrent infection incomplete.
“These Phase III RBX2660 results, as part of the overall clinical development program, show consistent efficacy as early as a first recurrence of C. difficile infection by delivering a broad consortium of live microbes to the area of active infection.”
Christine Lee, MD, and RBX2660 clinical trial investigator who presented the data at DDW said: “People who suffer from C. difficile infection are devastated when they experience recurrence.
“Patients have told me that they felt hopeless when the infection returned again and again despite multiple courses of antibiotic treatment. They believed that the infection would never go away.
“The findings from this pivotal Phase III trial of RBX2660 are very encouraging to both patients and healthcare providers, providing hope this potential new treatment could make a meaningful difference in the lives of patients with recurrent C. difficile infection.”
C. difficile is a bacterium that causes debilitating symptoms such as severe diarrhoea, fever, stomach tenderness or pain, loss of appetite, nausea, and colitis.
It is estimated to cause up to half a million illnesses and thousands of deaths annually in the US alone every year, C. difficile infection is considered an urgent threat to public health by the Centres for Disease Control and Prevention and can lead to severe complications, including hospitalisation, surgery, sepsis, and death.
Lilly Subbotin
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