Rebiotix delivers a gut bug PUNCH in C. diff trial
pharmafile | April 13, 2017 | News story | Research and Development | C diff, C. diff, Rebiotix, microbiome
Rebiotix is one a new breed of companies that aims to use the human body’s microbiome to treat illnesses and conditions caused by an imbalance within this system. It recently announced that this method of treatment, in recurrent clostridium difficile (C. diff), had proved to be particularly effective in a Phase 2 trial.
The trial, PUNCH Open Label, was able to display a treatment success rate of 78.8%, with its RBX2660 treatment – a broad-spectrum microbiota suspension designed to rehabilitate the human microbiome. The treatment works by delivering live microbes directly into a patient’s intestinal tract to treat the disease, in this case via enema.
The treatment has already shown enough promise to gain Orphan Drug status, Fast Track status and to be given Breakthrough Therapy Designation from the FDA. This partially due to the fact that C.diff infections are associated with 29,000 deaths per year, in the US, and the infection, after standard treatment through antibiotics, returns in a quarter of cases.
Lee Jones, President and CEO of Rebiotix, stated, “The 78.8% treatment success achieved in this open-label Phase 2 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 2b and Phase 2 clinical trials, position Rebiotix to advance RBX2660 into Phase 3 clinical development, solidifying our standing as the most clinically advanced microbiome company in the industry.”
The next step for the treatment, as mentioned by Jones, is to advance to Phase 3 trials, which is reported to be planned to begin enrolment in June. The Phase 2 trial reported that the treatment was generally ‘well-tolerated’, with adverse events reported to be gastrointestinal issues, such as diarrhoea and abdominal pain.
The company is also conducting a Phase 1 trial into oral formulation of the same drug, as more convenient form of treatment.
Ben Hargreaves
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