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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
"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.