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Vibrant's Novel Drug-Free Treatment Demonstrates Positive Efficacy and Safety Results in Adults with Chronic Idiopathic Constipation in Pivotal Phase 3 Study
News provided byVibrant
May 22, 2022, 7:54 PM ET
- The Phase 3 data met all primary endpoints for complete spontaneous bowel movements (CSBMs) per week and showed significant improvement in secondary outcomes versus placebo
- Data validates Vibrant as a safe and well-tolerated option to address unmet treatment needs in chronic idiopathic constipation (CIC)
- Company submitted Phase 3 data to the U.S. Food and Drug Administration for clearance
NANTUCKET, Mass., May 22, 2022 /PRNewswire/ -- Vibrant Gastro, a medical technology company that developed a proprietary, drug-free treatment for chronic idiopathic constipation (CIC) in adults, today presented data results from its positive Phase 3 study at the 2022 Digestive Disease Week Conference. The data shows that Vibrant significantly improved complete bowel movement frequency, constipation symptoms, and quality of life in adults with CIC while providing a safe and well-tolerated safety profile.
"This research demonstrates that Vibrant's unique drug-free mechanism of action significantly improves patients' overall constipation symptoms and quality of life," said Lior Ben-Tsur, CEO, Vibrant. "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."
The Phase 3 trial evaluated the safety and efficacy of Vibrant System in 312 CIC patients at over 90 clinical centers across the U.S., including Harvard Medical School, Augusta University, Georgia Health Sciences University, University of Michigan, and Houston Methodist Hospital.
Highlights from Phase 3 Data
- The trial met all primary endpoints for complete spontaneous bowel movements (CSBMs) per week and showed significant improvement in secondary outcomes versus placebo.
- 39.26% of patients receiving Vibrant System had one or more additional CSBMs per week, compared to baseline vs. 22.15% in the placebo group (p<0.0001).
- 22.7% of patients receiving Vibrant System had two or more additional CSBMs per week, compared to baseline vs. 11.41% in the placebo group (p<0.0006).
- Data showed significant improvement in secondary outcomes vs. placebo for stool consistency (p<0.001), quality of life (p=0.0020), and straining (p<0.0139).
- No severe adverse events or treatment-related diarrhea or nausea were recorded.
"The goal of Vibrant is to address a significant unmet treatment problem in chronic constipation, which has made life very challenging for those who suffer from it. We believe Vibrant presents a meaningful step toward achieving that goal," said Satish Rao, M.D., Ph.D., professor of medicine, and one of the primary study investigators.
Vibrant's drug-free mechanism of action is based on the scientific understanding that the circadian rhythm, otherwise known as "the biological clock," plays an important role in our biological digestive process. When the biological clock is out of synch, people are more likely to experience constipation. Vibrant's technology resynchronizes the biological clock through mechanical stimulation of the colon, likely leveraging the Gut-Brain connection, resulting in improved bowel movements, constipation symptoms relief, and better quality of life.
"Additionally, as we innovate in the gastroenterology space, we have the opportunity to help millions of CIC patients gain access to novel drug-free treatments that offer predictable, affordable, and effective choices to manage their frequent and bothersome symptoms," shared Catherine Collis, Vibrant's CCO.
Based on the Phase 3 results, Vibrant has submitted its system to the U.S. Food and Drug Administration for clearance.
Vibrant is the pioneer of a unique mechanism of action for the treatment of chronic idiopathic constipation (CIC), based on the scientific understanding that when the biological clock is out of synch, people are more likely to experience constipation.
The orally administered drug-free disposable capsule is directed by a pod, which activates and sends the operating instructions to the capsule. The capsule, once ingested, resynchronizes the biological clock through mechanical stimulation of the colon, resulting in improved bowel movements, constipation symptoms relief, and better quality of life.
The treatment's companion app, assisting patients to self-track their treatment progress, helps obtain a better state of health.
The Vibrant capsule is an investigational device limited to investigational use in the United States. It is currently under FDA review and is not available for sale.
To learn more about Vibrant, visit www.vibrantgastro.com.
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