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RBX2660 Could Heal Recurrent C Diff Patients, Physically and Psychologically

C diff patients live in fear of a recurrence, says gastroenterologist Paul Feuerstadt, MD. RBX2660 has entered the FDA pipeline and looks to end this vicious cycle.

Last week, a Food and Drug Administration (FDA) advisory committee voted to recommend a Biologics License Application (BLA) for RBX2660, a treatment for recurrent Clostridioides difficile infection (CDI).

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 13 to 4 in favor of the efficacy of RBX2660 and 12 to 4 in favor of the safety of RBX2660 (with 1 abstention).

Contagion spoke with Paul Feuerstadt, MD, about what the VRBPAC vote means and the promise of RBX2660 therapy for this vulnerable patient population.

RBX2660 is an investigational microbiota-based live therapy. It combats the dangerous cycle of C diff recurrence by restoring the gut microbiome.

Approximately half a million Americans are diagnosed with CDI each year. Of these patients, Feuerstadt says, 25-35% will have an initial recurrence, 40-50% will have a second recurrence, and up to 60% will have a third recurrence.

Feuerstadt says that the “rudimentary” solution for recurrent CDI is a fecal microbiota transplant (FMT). “RBX2660 is a much more sophisticated approach,” he explained, citing the broader screening approach for both the donor and donor specimen.

The RBX2660 administration takes the form of an enema, Feuerstadt says, and is a pre-packaged single dose of 150 mL microbiota suspension from individual human stool donation.

Feuerstadt describes how tragically easy it is for CDI patients to get trapped in the vicious cycle of recurrence. Not only are recurrences a drain on patient health and hospital resources, but there is psychological damage as well.

“The effect on patients is so profound,” said Feuerstadt. “Believe it or not, there’s a post-traumatic stress disorder that comes with this…We have seen that impact last years into the future.” Patients live in fear of an embarrassing and debilitating recurrence, he said, long after being cured.

“The future is incredibly bright for the treatment of C difficile,” Feuerstadt said, “and that’s something I can’t understate.”

RBX2660 is a biotherapeutic developed by Ferring Pharmaceuticals. Before the positive VRBPAC vote, RBX2660 was granted Fast Track, Orphan, and Breakthrough Therapy designations by the FDA.

Dr. Feuerstadt is an assistant clinical professor of medicine at the Yale School of Medicine in New Haven, Connecticut, and an attending gastroenterologist at the Physicians Alliance of Connecticut (PACT) gastroenterology center.