The FDA has granted clearance to the Epitomee capsule, a novel ingestible device designed to aid in weight management for adults with a body mass index (BMI) between 25 and 40 kg/m2. This clearance allows the capsule to be used in conjunction with lifestyle modifications, offering a new approach to combating overweight and obesity.
The Epitomee capsule is self-administered and works by expanding within the stomach after ingestion, occupying space and inducing a sensation of fullness. This mechanism aims to reduce food intake and promote weight loss. After several hours, the device moves into the intestines, where it breaks down and is naturally eliminated from the body via the gastrointestinal tract.
The FDA's decision was supported by data from the RESET trial (NCT04222322), a randomized, double-blind, placebo-controlled study involving 279 overweight and obese adults, some of whom had prediabetes. Participants were randomly assigned to receive either the Epitomee capsule or a placebo twice daily, alongside a diet and exercise regimen. The results indicated a statistically significant difference in weight reduction among those who received Epitomee compared to the placebo group (P < .0001). Furthermore, 55.5% (95% CI, 46.1-64.6) of patients in the Epitomee group achieved a clinically meaningful weight loss of at least 5% of their baseline body weight after 24 weeks, meeting the criteria for treatment responders.
The safety profile of Epitomee for extended use was evaluated in the ELECT trial (NCT04994769), an open-label, single-arm study. This trial included patients who had completed the 24-week treatment period with Epitomee and experienced at least a 3% weight loss. The results demonstrated a favorable safety profile for participants who continued using the device for the entire 48-week treatment period.
"Our capsule offers a safe, effective, and drug-free solution to the many millions of individuals struggling with weight management," stated Dan Hashimshony PhD, CEO of Epitomee Medical Ltd. "As we move forward, we are eager to bring this groundbreaking product to the US market and seek strategic partnerships to fully realize its commercial potential."
