Microbiome company Rebiotix has reported a positive outcome for RBX2660 from the Phase II PUNCH clinical trial for the prevention of recurrent Clostridium difficile (C. diff.) infection.

RBX2660 is a broad-spectrum microbiota suspension being developed to deliver live microbes into the intestinal tract of a patient in order to restore the human microbiome.

The trial's top-line results showed that RBX2660 was well-tolerated and met the primary efficacy endpoint by preventing the recurrence of the infection.

The prospective, multi-centre, open-label, controlled Phase II trial was conducted at 31 active treatment sites and four control sites in the US and Canada.

The trial evaluated the efficacy and safety of RBX2660 in 132 patients. It also included 110 historical control participants.

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"The trial's top-line results showed that RBX2660 was well-tolerated and met the primary efficacy endpoint by preventing the recurrence of the infection."

Rebiotix president and chief executive officer Lee Jones said: "The 78.8% treatment success achieved in this open-label Phase II trial demonstrates the potential of RBX2660, a broad spectrum microbiota drug product, to rehabilitate the gut microbiome and break the cycle of C. diff. recurrence.

"These results, coupled with the safety and efficacy data observed in our prior Phase IIb and Phase II clinical trials, position Rebiotix to advance RBX2660 into Phase III clinical development, solidifying our standing as the most clinically advanced microbiome company in the industry."  

The trial's primary efficacy endpoint was a comparison of RBX2660 treated patients with subjects treated with antibiotic only historical controls over a period of 56 days.

RBX2660 was found to demonstrate a treatment success rate of 78.8% when compared to the 51.8% shown by historical control.

Image: Clostridium difficile colonies on a blood agar plate. Photo: CDC/Dr. Holdeman.