Vibrant Gastro has announced positive Phase III study results of its drug-free treatment for chronic idiopathic constipation (CIC) in adult patients.
The trial of the company’s Vibrant System enrolled 312 CIC patients at more than 90 clinical centres across the US, including Harvard Medical School, Augusta University, University of Michigan, Georgia Health Sciences University and Houston Methodist Hospital.
Evaluating the Vibrant System’s safety and efficacy, the trial found that the system significantly improved adult CIC patients’ constipation symptoms and quality of life, as well as the frequency of complete bowel movements.
Furthermore, the treatment provided a safe and well-tolerated safety profile.
Vibrant CEO Lior Ben-Tsur said: “This research demonstrates that Vibrant’s unique drug-free mechanism of action significantly improves patients’ overall constipation symptoms and quality of life.
“Vibrant offers healthcare providers a new tool to expand chronic constipation treatment options and may provide a cost-effective solution for chronic constipation for health systems and insurance companies.”
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The pivotal Phase III study met all primary endpoints for complete spontaneous bowel movements (CSBMs) per week.
Significant improvement was also observed in secondary outcomes versus placebo.
Neither severe adverse events nor diarrhoea or nausea related to the treatment were recorded in the trial.
Vibrant has been validated as a safe and well-tolerated option for addressing unmet treatment needs in CIC.
Vibrant Gastro submitted the Phase III results to the US Food and Drug Administration (FDA) to obtain clearance for the system.
The company’s orally administered drug-free disposable capsule is currently limited to investigational use in the US.
Activated by a pod and featuring a companion app, the device allows patients to track their treatment progress and obtain an improved state of health.