Epitomee Medical has reported that outcomes from the RESET study have revealed the total body weight for patients who received the Epitomee Capsule – an FDA approved ingestible medical device designed to support weight management in adults with a BMI25–40kg/m² alongside diet and exercise - was reduced by at least 5% at 24-weeks.
The Epitomee device is encased in a standard size, self-administered ingestible capsule. Once the Epitomee Capsule is swallowed and reaches the stomach it absorbs water in the stomach and creates a three-dimensional matrix designed to occupy volume in the stomach creating a sensation of fullness, enabling weight loss. The Epitomee Capsule mechanism of action is purely mechanical and does not involve any chemical activity. The capsule works directly in the gastrointestinal (GI) tract.
“Epitomee capsule is a safe and effective, non-pharmacological option for weight management with broad application in patients with overweight or obesity,” explained Professor Jamy D Ard, Wake Forest University School of Medicine and President of The Obesity Society, who presented the results at ObesityWeek 2024. “Because the Epitomee treatment was found to be safe and well-tolerated, it can be used for a wide variety of patients, even those who might not tolerate other medications or have contraindications for those medications"
The RESET study is a randomised, double-blind, placebo-controlled study assessing the safety and efficacy of the Epitomee Capsule. Patients were randomised to Epitomee (n=138) or placebo (n=141). The study demonstrated that both co-primary endpoints were successfully met. The RESET study demonstrated significantly better weight loss among the device group compared to the control group (p<0.0001). The co-primary endpoint of treatment responders was also achieved: the rate of Epitomee treatment group subjects whose total body weight was reduced by at least 5% at 24-weeks post randomization was 55.5%, significantly exceeding the threshold of >35% (p<0.0001).
The study also reported:
~60% of the Epitomee group were found to be early responders, identified as those losing at least 2% of body weight at week 8 achieving an average of ~10% weight loss at week 24.
Significant reductions of change from baseline in HOMA-IR (p<0.007) and in insulin levels (p<0.003) which were seen in Epitomee-treated patients with prediabetes versus placebo.
Epitomee treatment significantly improved all QOL domains and Total scores in comparison to baseline and significantly outperforms the placebo in improving Total QOL and Physical Function Scores.
There were no serious adverse device effects (SADEs) in the study and no difference between groups in overall and in gastrointestinal-related AEs.
"Epitomee offers a very safe approach that patients can use when they need help with appetite control – it's taken before meals. Epitomee is not absorbed – it acts in the stomach and thus, it has none of the side effects that we expect with the GLP-1 meds,” explained Dr Donna H Ryan, Professor Emerita at Pennington Biomedical Research Center. “Patients can eat healthy meals of real food and still lose weight by feeling fuller sooner. Epitomee is a good addition to our treatment toolbox – the safety, tolerability and efficacy profile make it a good fit for many patient types and for both weight loss and to aid in weight loss maintenance. We see a significant advantage in using Epitomee for individuals starting at a BMI of 25, a category where most anti-obesity medications are still not approved, regardless of whether additional health complications are present."
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