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RBX2660 was the first ever live microbiota therapeutic to gain approval from the FDA for rCDI.
In the latest iteration of data from the PUNCH-CD3 trial, investigators found a clonally-resolved metagenomic species (MSG)-based approach is the top choice for assessing engraftment among live biotherapeutic products bacterial populations.
In data presented during the 2023 Digestive Disease Week (DDW) in Chicago, a team of investigators led by Ken Blount, PhD, Chief Scientific Officer, Rebiotix and VP Microbiome Research, Ferring Pharmaceuticals, found that the live microbiota therapeutic RBX2660 (Reybota) was associated with clonal engraftment of RBX2660 microbiota into trial participants, with Bacteroidia- and Clostridia-class bacteria as the most effective engrafters.
In the study, the investigators examined adult patients enrolled in the PUNCH CD3 trial with at least 1 recurrent Clostridioides difficile infections (rCDI) episode. The patients were treated with a single blinded dose of RBX2660 or placebo.
The patients in the RBX2660 group who achieved 8-week treatment success showed gut microbiota restoration to a composition and diversity similar to the healthy control group as soon as 1 week following treatment.
In addition, successful outcomes were significantly associated with greater levels of clonal engraftment from RBX2660 (P <0.001).
In an interview with HCPLive®, Blount described the importance of the trial and what are some of the opportunities to study RBX2660 further in the future.