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RBX2660 showed similar efficacy and safety in treating patients with and without immunocompromised conditions.
Since it has been a few months since the US Food and Drug Administration (FDA) approved RBX2660 (Rebyota) for the prevention of recurrent Clostridioides difficile infections (rCDI), it is now important to focus research on the efficacy and safety of the treatment in different patient subgroups.
In data presented during the 2023 Digestive Disease Week (DDW) in Chicago, investigators found RBX2660 resulted in no new safety signals, while sustaining efficacy in a subgroup of immunocompromised patients.
The data was part of the PUNCH CD3 trial, which was the main source of data that led to the 2022 FDA approval of RBX2660.
In the latest iteration of data, 18.8% (n = 91) of patients had an immunocompromising conditions, the majority of which were secondary to medication use.
There were similar rates of treatment-emergent adverse events in patients with and without immunocompromising conditions (64.8% vs. 62.0%). The majority of these were mild or moderate and related to CDI or a preexisting condition.
In addition, treatment success rates were comparable between the 2 groups (79.5% vs. 73.5%).
In an interview with HCPLive® Glenn S. Tillotson, PhD, FIDSA, FCCP, Senior Consultant GST Micro, explained why it was important that investigators test RBX2660 in this patient population.
“I think it is very important because phase 3 studies are a very select bunch of patients,” Tillotson said. “I think knowing you have the ability to restore the microbiota with a good success rate not just in your phase 3 population, but it works very well in a heterogenous population as well.”