Epitomee has submitted its weight loss capsule that offers an innovative, orally administered, drug free, and clinically proven as effective and safe solution, for adults, who are looking to lose weight, for FDA clearance in the US. The proposed indication covers the broadest Body Mass Index (BMI) range of 25 to 40 kg/m2, even without comorbidities, when used in conjunction with diet and exercise.
Epitomee’s platform technology is based on self-expanding hydro-gel scaffolds folded into a standard pharmaceutical capsule, produced from biocompatible excipients, food additives and food contact materials. The hydro-gel scaffolds can be engineered to be triggered by different zone-specific pH levels, allowing the allocation of an indication-specific deployment region for every product to enable an optimal therapeutic effect. The use of biodegradable, organic and pH sensitive polymers enables a pre-determined duration of activity and a mechanism for initiation of cessation, resulting in a safe and comfortable user experience.
The device is swallowed with 2 cups of water and the outer capsule dissolves when exposed to target site pH. The hydrogel particles absorb surrounding fluid and swell, expanding the device scaffolds into a semi rigid triangular shape as a reaction to stomach’s pH levels. The devices each have their unique expansion- disintegration profile and perform their therapeutic purpose for a pre-determined period of time. Once contact is achieved the biologic payload is released in a controlled manner for a predetermined period of time. After the elapsed deployment period, the scaffolds disintegrate and flow freely down the GI tract.
"The Epitomee capsule represents a significant enhancement to the arsenal for weight management" said Professor Donna Ryan, former president of the World Obesity Federation. "It is an effective and safe treatment for overweight & obesity, promoting weight loss and improvement in Quality of Life. It offers a promise in prevention of progression of diabetes in persons with pre-diabetes and is associated also with improvements in blood pressure, lipids and waist circumferences. Given its outstanding safety record, the favourable risk-to-benefit ratio underscores its importance as a viable option for broad application".
In January 2024, the company revealed it had successfully completed the RESET pivotal randomised clinical trial - a placebo controlled, double blind trial, that investigated the safety and efficacy of Epitomee capsule versus sham capsule control, alongside lifestyle interventions, for reducing body weight, in overweight or obese adults without comorbidities.
The trial was conducted in 9 different centres across the US. The RESET included 279 participants and was carried on for 24 weeks of treatment, followed by additional four-week monitoring period. The study successfully met both co-primary endpoints with a majority of Epitome patients (56%) achieving 5% or greater weight loss from baseline (p<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 group (p <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.
This submission is via the 510k regulatory pathway for medical devices. Notably, the Epitomee capsule has already received approval in the European Union and bears a CE mark. Upon FDA approval, the capsule will become available by prescription from healthcare professionals.