A panel of an FDA committee voted in favor of Ferring Pharmaceuticals' Rebyota fecal transplant-based therapy to minimize the recurrence of the bacterial infection Clostridioides difficile infection (CDI), which occurs in adult patients.
Laboratory Analysis Chemistry
Ferring Pharmaceutical's Rebyota
According to Reuters, Rebyota (RBX2660) works by replenishing beneficial gut bacteria using microbe samples purified from healthy donors' feces and administered through an enema. Rebyota targets CDI, a superbug that causes infections that can lead to serious and life-threatening diarrhea.
According to Paul Feuerstadt, assistant clinical professor of medicine at Yale University School of Medicine, RBX2660 is consistently safe and effective irrespective of the patient's medical history or demographics. He stated that it applies to the idea that individuals can be treated broadly with this and have very effective symptomatic relief of their recurrent CDI in a sustained manner.
The clinical professor was optimistic about it, believing that the future is truly bright for patients with recurrent CDI as more data is gathered and demonstrating the broad applicability of medications such as RBX2660.
FDA Votes and Points of View on the Therapy
The Advisory Committee on Vaccines and Related Biological Products voted 13-4 in favor of adequate data proving effectiveness. The vote is 12-4, with one abstention, for the provision of appropriate data supporting safety.
Despite the information offered, several committee members felt the data was insufficient for the proposed vote questions.
After reviewing all of the information before the meeting, Henry Bernstein, professor of pediatrics at Hofstra University and Cohen Children's Medical Center, indicated he was leaning toward two (no votes). However, listening to both the presentations and the conversations around the table convinced him that, while there is a minor benefit in terms of safety, there is a significant need for patients to have this alternative.
Trials, Analysis of Rebyota RBX2660
Representatives from Rebiotix submitted evidence in support of the ruling, reporting on data from 978 people who received at least one dosage of Rebyota in six clinical trials. To support its efficacy, they emphasized outcomes from phase 2 and phase 3 randomized, double-blind, placebo-controlled trials.
In the phase 2 trial, 128 people were randomly assigned to receive two enema doses of RBX2660, two enema doses of placebo, or a combination of RBX2660 and placebo.
Researchers assessed the safety and efficacy of RBX2660 in the prevention of recurrent CDI in 289 people in the phase 3 trial.
In the intent-to-treat analysis, participants dosed with RBX2660 had a 70% success rate compared to 60.9% for those given placebo. Data from pooled assessments of all people exposed to at least one study treatment were included in the consolidated summary of safety. Adverse events occurred in 66.4% of people who took one dose of RBX2660, 80.3% of people who received two doses, 78.6% of people who got three doses, 91.7% of people who got four doses, and 72.5% of people who got any dose of RBX2660.
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Antibiotics, Fecal Microbiota Transplantation
According to Helio, antibiotics are the first-line treatment for CDI, which causes over 500,000 infections in the US each year; but they can also destroy the healthy gut bacteria that prevent recurrences.
Nonetheless, firms other than Switzerland's Ferring make an effort to use fecal microbiota transplantation (FMT). Seres Therapeutics (MCRB.O) is one of these firms, and it is developing an oral therapy based on FMT.
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