RBX2660 was originally approved by the FDA in 2022 and came to market in January 2023.
With the US Food and Drug Administration (FDA) approval now complete and the drug already on the market, investigators are directing much of the energy in RBX2660 (REBYOTA) research on different subanalyses of patients.
In data presented during the 2023 Digestive Disease Week (DDW) in Chicago, a team led by Jessica Allegretti, MD, MPH, Brigham & Women’s Hospital, found that the live microbiota therapeutic resulted in no new safety signals for patients with inflammatory bowel disease (IBD) who were treated with RBX2660 for recurrent Clostridioides difficile infections (rCDI).
In the ad-hoc analysis of the ongoing Phase 3 PUNCH CD3-OLS trial, the investigators evaluated the safety of 547 total patients, 18 of which had Crohn’s disease and 38 had ulcerative colitis. Of this patient population, 69.6% (n = 39) received IBD-related medications when RBX2660 was administered.
The results show that 82.1% (n = 32) did not experience any IBD0-related medication changes after 8 weeks, while 7 patients stopped or initiated concomitant medication within 8 weeks of treatment. Treatment emergent adverse events were comparable in patients with or without IBD and mostly gastrointestinal in nature.
In an interview with HCPLive®, Allegretti explained the promising results and discuss what has been learned during the first few months of using RBX2660 in clinical practice.