SAN CARLOS, Calif. /PRNewswire/ -- BAROnova, Inc., a clinical stage medical device company focused on the development of non-surgical solutions for the treatment of obesity, announced today the presentation of primary results of its pivotal trial, the ENDObesity II study, as a late-breaking clinical trial, at the scientific sessions of the 2018 Obesity Week conference.
The ENDObesity II study was a randomized, double-blinded, sham-controlled study that assessed the safety and effectiveness of the TransPyloric Shuttle Device for the treatment of obesity in patients with a body mass index of 30-40 kg/m2. Primary endpoints were percent total body weight loss (%TBL) at twelve months follow up after the procedure and the proportion of people in the treatment group who achieved 5% TBL or more after 12 months.
Individuals treated with the investigational TPS device on average lost three times (3x) more weight when compared to the sham-control group (9.5% for the TPS group and 2.8% for the Control, p<0.0001) at the 12-month follow up. Approximately 67% of people treated with TPS lost 5% or more of their body weight, exceeding the pre-specified performance target of 50% (p<0.0001). Forty percent (40%) of people treated with TPS lost 10% or more weight (vs. 14% in sham-treated controls). A weight loss of 5% or more is considered clinically meaningful for achieving health benefit. People in the TPS group also demonstrated greater improvement in their blood pressure and other cardiometabolic risk factors as well as a significant improvement in their quality of life when compared to those in the control group.
"Obesity is a worldwide epidemic with up to 40% of adult Americans suffering from obesity and its associated co-morbidities. We need effective solutions that are safe and acceptable by physicians and by people who live with this chronic condition. The TransPyloric Shuttle represents the next generation of intragastric devices that was designed to address some of the undesirable side effects with the first-generation devices and offer longer treatment duration. Based on the successful results from this study, this treatment will likely find a very meaningful role in clinical practice, if approved by the FDA," said Dr. Richard Rothstein, the Joseph M. Huber Professor and Chair of Medicine for the Dartmouth Geisel School of Medicine, and the lead investigator for the ENDObesity II study who presented the results.
The ENDObesity II study enrolled 302 patients from nine investigational centers across the United States. In the trial, the most common adverse events among people treated with the TPS device were gastrointestinal events, such as stomach pain, nausea, vomiting, and dyspepsia, as expected with an intragastric device designed to treat obesity through delay gastric emptying.
"We are pleased to see the magnitude of weight loss and significant clinical benefit demonstrated in the study. Based on the positive pivotal study results, we have submitted the PMA application to the FDA," said Lian Cunningham, M.D, PhD, Senior Vice President of Clinical Affairs and Regulatory Affairs of BAROnova Inc.. "We would like to thank all our clinical investigators and their staff for their contribution to the success of this trial. We look forward to bringing this new technology to patients and physicians if approved by the FDA."
Obesity is defined as a Body Mass Index (BMI) >30 kg/m2. Individuals with obesity are at increased risk of developing over 70 comorbid conditions including hypertension, hyperlipidemia, and type 2 diabetes. Obesity is a worldwide epidemic that has placed a major burden on healthcare systems globally. There are currently over 75 million adults in the United States with a BMI between 30-40 kg/m2 and over 600 million adults worldwide who are candidates for a safe and effective non-surgical therapy.
About the TransPyloric Shuttle
The TransPyloric Shuttle is a novel investigational device that is designed to be inserted and removed trans-orally using standard endoscopic techniques. It is mechanically constructed using solid silicone components and is not subject to inflation or deflation risks. The device is intended to reside in the stomach for 12 months. The TransPyloric Shuttle's primary mechanism of action is delayed gastric emptying which is a known mechanism of weight loss. If approved by the FDA, the TPS will be the first and only intragastric device with a 12-month treatment duration available in the United States.
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