US-based biotechnology firm Rebiotix has started treatment for patients with recurrent Clostridium difficile-associated diarrhoea (CDAD) as part of its PUNCH CD Phase II clinical trial of RBX2660 (microbiota suspension), a drug preparation containing live human-derived microbes.
The main aim of the multi-centre, open-label trial is to evaluate the safety of RBX2660, which represents the first drug product in the company’s Microbiota Restoration Therapy (MRT) platform.
Secondary objectives of the trial include gathering data on the efficacy and cost-effectiveness of the therapy.
Around 40 patients will participate in the study, which will be carried out at some 20 sites in the US and Canada, while they will also be followed for six months after treatment.
RBX2660 is designed to reverse pathogenic processes and restore the normal microbiota through the transplantation of live microorganisms.
Rebiotix CEO Lee Jones said: "RBX2660 has the potential to reduce dependence on antibiotics which have been shown to have limited effectiveness in treating multiply recurrent CDAD."
The RBX2660 clinical program had already received fast-track designation from the US Food and Drug Administration as it recognised the urgent need for a new therapy for recurrent Clostridium difficile infection (CDI).
The fast-track status will help in the development and speed-up the review of new drugs or biologic products to be used for treatment of serious or life-threatening conditions and that show the potential to address unmet medical needs.
MRT was developed following the failure of the faecal transplant therapy to be widely adopted due to challenges involved in donor screening and product preparation.
Rebiotix believes RBX2660, the first drug product in the company’s MRT platform, has the potential to treat disease by overwhelming the disease-causing bacteria and restoring a patient’s healthy gut microbial community.
If successful, RBX2660, has the potential to become the first FDA-approved drug based on the human microbiome.
More than 700,000 people in the US per annum are affected by CDI, a life-threatening intestinal infection that is usually hospital-acquired, with symptoms profuse watery diarrhea and abdominal pain.
Image: RBX2660 is intended for treatment of patients with recurrent Clostridium difficile-associated diarrhea (CDAD). Photo: courtesy of Angusmclellan.