TRACK RECORD: Reducing inflammation in Crohn’s disease and ulcerative colitis
In collaboration with specialists from Austin Health and the University of Melbourne, researchers at the Bionics Institute have developed a vagus nerve stimulation device, which will soon go into clinical trials to reduce inflammation in Crohn’s disease.
In 2015, the Bionics Institute responded to a call for submissions from the US based Defense Advanced Research Projects Agency (DARPA) to develop a treatment for inflammatory bowel disease, which is a common issue among service personnel.
Ideation, design and prototyping
A research team led by A/Professor James Fallon and Professor Rob Shepherd was established with DARPA funding to develop a novel vagus nerve stimulation device, positioned in the abdominal cavity. The team works closely with academic collaborators from the University of Melbourne led by Professor John Furness and clinical collaborators from Austin Health, led by A/Professor Peter de Cruz.
Proof of principle efficacy trials
Between 2015 and 2019, the Bionics Institute team developed a vagus nerve electrode cuff and with colorectal surgeon Mr David Proud at Austin Health refined surgical approaches to reduce inflammation in inflammatory bowel disease. They carried out preclinical validation in ‘proof of principle’ animal model safety and efficacy trials.
Regulatory pathways and intellectual property
The team has filed a number of patents to protect both the design of the electrode array and the methodology of treatment. Each of these patents have progressed to filing in the US, Europe and Australia. Clinical trial data will support the regulatory submissions to the FDA and European authorities.
First-in-human clinical trials
The first-in-human prototype devices were manufactured in the US with clinical trials in humans commencing when COVID restrictions allow. The device will be implanted during bowel resection surgery to prevent inflammation and recurrence of the disease.
A/Professor de Cruz says: “I feel incredibly privileged to be part of such a fantastic team that has taken a ‘proof of concept’ from pre-clinical research, to a world first-in-human clinical trial to assist Crohn’s disease patients.”