CAESAREA, Israel, Nov. 19, 2024 /PRNewswire/ — Epitomee Medical Ltd. (TASE: EPIT) announces that significant results from its RESET study on a novel oral hydrogel capsule for weight loss were presented at ObesityWeek® 2024. The prestigious event, organized by The Obesity Society (TOS), took place from November 2-6, 2024, in San Antonio, Texas.
The oral presentation, delivered by Professor Jamy D. Ard MD of Wake Forest University School of Medicine, highlighted the results of a randomized, double-blind, placebo-controlled study assessing the safety and efficacy of the Epitomee® Capsule. Professor Ard, an esteemed leader in obesity research and President of The Obesity Society, emphasized the potential impact of this innovative, drug-free capsule for weight loss. The Epitomee capsule works by expanding into a triangular shape in the stomach, enhancing satiety, reducing appetite and calorie intake through a non-pharmacological mechanism.
Results of the RESET Study: Patients were randomized 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% (CI; 46.1-64.6), significantly exceeding the threshold of >35% (P<0.0001).
~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.
Donna H. Ryan MD, Professor Emerita at Pennington Biomedical Research Center, shared her perspective on Epitomee capsule:
“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. 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.”
Reflecting on the study’s success, Professor Jamy Ard stated, “Epitomee capsule is a safe and effective, non-pharmacological option for weight management with broad application in patients with overweight or obesity. 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“
About The Obesity Society (TOS): As the world leading professional organization focused on obesity science and treatment, TOS’s annual ObesityWeek® conference brings together experts to discuss advancements in obesity care, including clinical applications, research, and policy initiatives.
About Epitomee Medical Ltd.: Epitomee Medical Ltd. is a pioneering technology based health solutions company, committed to advancing innovative therapies. The company is advancing two major fields: weight management and biologic drug delivery. In addition to its flagship weight management solution, Epitomee Medical is developing a cutting-edge platform focused on the oral delivery of biologics. This innovative platform is designed to transport drugs to the absorption site with enhanced bioavailability.
For partnership inquiries and more information about the weight-management capsule, please contact: Mr. Alon Heth
VP Sales and Marketing
[email protected]
For more information about Epitomee Medical Ltd., please visit Epitomee Medical at: www.epitomeemedical.com
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SOURCE Epitomee Medical
