BaroNova late last week released the primary results from the pivotal ENDObesityII study of its TransPyloric Shuttle device intended to treat obesity.
Results from the trial were presented at the Obesity Week 2018 conference’s scientific sessions, the San Carlos, Calif.-based company said.
“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,” ENDObesity II lead investigator Dr. Richard Rothstein of the Dartmouth Geisel School of Medicine, who presented the results, said in a prepared statement.
Investigators in the 302-patient ENDObesity II trial analyzed the safety and effectiveness of the TransPyloric Shuttle Device in treating obesity in patients with a body mass index of between 30-40kg/m2.
The trial had primary endpoints of the percent of total body weight loss at one year follow-up post-procedure and the proportion of people in the treatment group who achieved 5% total body weight loss or more at one year, BaroNova said.
Results indicated that patients treated with the investigational TPS device lost an average of three times more weight compared to the sham-control group at 9.5% versus 2.8%, respectively, at twelve months. Data also indicated that 67% of patients treated with the TPS system lost 5% or more of their body weight, which exceeded the pre-specified 50% target for the trial, BaroNova said.
A total of 40% of people treated with TPS lost 10% or more weight, the company said, and those in the TPS arm of the study showed greater improvement in blood pressure and other cardiometabolic factors and improvements in their quality of life as compared with the control group.
The most common adverse events in the trial were gastrointestinal events including stomach pain, nausea, vomiting and dyspepsia.
“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. 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,” clinical & regulatory affairs senior VP Dr. Lian Cunningham said in a press release.