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CAESAREA, Israel, Jan. 16, 2024 /PRNewswire/ -- Epitomee® announces the successful completion of the RESET pivotal clinical trial, for its weight loss capsule. The randomized placebo controlled, double blind trial, investigated the safety and efficacy of Epitomee® capsule versus the sham capsule control, alongside lifestyle interventions, for reducing body weight, in overweight or obese adults, with BMI of 27-40 without comorbidities, The trial was conducted in 9 different centers across the United States.
The primary objective of the RESET trial was to collect data to support a planned FDA regulatory submission, paving the way for the marketing and distribution of the Epitomee® capsule in the USA. The RESET included 279 participants and was carried on for 24 weeks of treatment, followed by additional 4-week monitoring period. The study successfully met both co-primary endpoints: with Epitomee®, majority of patients, 56%, achieved 5% or greater weight loss from baseline, with a p-val<0.0001 relative to the required threshold of 35%. Additionally, patients using Epitomee® lost more of their baseline body weight than the control group, demonstrating the superior efficacy of Epitomee® over the control with a p-val <0.0001.
Notably, the majority of Epitomee® completers achieved, in 24 weeks, between 5% and 15% or greater weight loss. Noteworthy, 27% of participants lost at least 10% of their body weight and 11% achieved a 15% or more weight reduction.
Importantly, the study demonstrated a favourable safety profile of Epitomee®. There were no device-related serious adverse events (SAEs) and no differences in the incidence of treatment-emergent AEs between the study groups.
The RESET trial also evaluated the change in quality of life (QOL) from baseline to week 24, through the IWQOL-Lite-CT score, demonstrating an improvement in various aspects of QOL in the Epitomee® group, compared to the control group.
"The effectiveness and safety of Epitomee® capsules were clearly demonstrated in the RESET trial for individuals dealing with overweight and obesity. Epitomee® has also showcased its potential to enhance the quality of life for those on their wellness journey," says Dr. Shimon Eckhouse, Chairman of the Board of Epitomee®.
"Epitomee® is committed to delivering a premium product, tailored to health-conscious individuals, dedicated to sustainable weight loss. We are developing a valuable addition to the weight management toolbox and seeking further international commercial partnerships to build the market presence and facilitate the successful introduction of our products." says Dan Hashimshony, PhD, CEO of Epitomee®.
About Epitomee®:
Epitomee® is a pioneering health solutions company, committed to advancing innovative therapies. With focus on safety, efficacy, and improving quality of life, Epitomee® strives to be at the forefront of transformative healthcare solutions.
Epitomee® is a public company (TASE: EPIT)
The Epitomee® capsule is not yet available for sale in the United States.
For more information:
For inquiries and partnership opportunities, please contact:
Safi Landskroner VP BD & Marketing
safi@epitomeemedical.com