Preliminary positive results seen for microbiome-based C. diff treatment
A new microbiome-based treatment for Clostridioides difficile infection showed success in reducing recurrence of the infection at 8 weeks, according to preliminary results released by the manufacturer.
“With RBX2660 and other microbiome restoration therapies, the things that are most exciting about these therapies is that we will finally be able to offer a standardized product and therapy to our patients,” Sahil Khanna, MBBS, of Mayo Clinic, told Healio Gastroenterology and Liver Disease. “RBX2660 is distinct from other therapies in several ways. One, it’s standardized. ... Two, it’s a non-invasive, enema-based therapy so patients don’t need a bowel preparation. Patients don’t need to have anesthesia, no need for sedation or a colonoscopy.”
RBX2660 (Rebiotix/Ferring Pharmaceuticals) is a live biotherapeutic that is designed to “help restore the gut microbiome community,” according to the press release.
The primary endpoint of the phase 3 randomized, multicenter, double-blinded, placebo-controlled study, which is still ongoing, is recurrence of CDI at 8 weeks. According to the manufacturer, “RBX2660 showed statistically significant success over placebo meeting the preliminary primary efficacy endpoint.”
“What is most exciting is that RBX2660 is the first FMT product used to prevent recurrence of C. difficile to meet its primary clinical end-point in both phase 2 and phase 3 clinical trials. This speaks to the efficacy of this product and the robust nature of the data to support its usage, if approved by the FDA,” Paul Feuerstadt, MD, FACG, AGAF, of Gastroenterology Center of Connecticut, told Healio via email. “If RBX2660 is reviewed by the FDA and approved, this treatment will be much more widely available to many practitioners who did not have access to FMT previously or did not feel comfortable with the data to support FMT when there was not an FDA-approved formulation. With epidemiologic trends showing more and more patients having multiple recurrences of C. difficile, RBX2660, as a form of fecal transplantation, will likely move earlier in the treatment algorithm for many more providers. This should prevent patients from having multiple recurrences thereby decreasing the massive burden of this infection on our healthcare system.”
The data are not yet unblinded while the safety follow-up is conducted, but the finalized data are expected in the second half of the year, a Rebiotix and Ferring Pharmaceuticals representative said.
“C. diff infection is a significant public health threat that has limited treatment options. These positive preliminary findings represent a major step forward toward bringing an innovative, non-antibiotic option to patients that may help restore their gut microbiome,” Per Falk, Ferring’s President and Chief Science Officer, said in the press release. “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 company plans to present the data to the FDA this year. – by Katrina Altersitz
Reference: Rebiotix press release.
Disclosures: Khanna reports financial relationships with Facile Therapeutics, Ferring Pharmaceuticals, Premier Inc, Probio Tech LLC, Shire Pharmaceuticals and Vedanta. Feurstadt reports serving on advisory committees or review panels and consulting for Ferring Pharmaceuticals, speaking and teaching for Merck and consulting for Roche Pharmaceuticals.