An Israeli startup, Epitomee, has successfully concluded clinical trials for its groundbreaking drug-free weight-loss pill, marking a significant step towards approval by the US Food and Drug Administration (FDA).
Epitomee, headquartered in Caesarea, has engineered an ingestible capsule designed to unfold within the stomach, exerting pressure on the stomach wall to induce a sense of satiety. CEO Dr. Dan Hashimshony emphasized the complexity of turning this concept into reality, stating, “That’s something that’s easy to say, but making it happen is very challenging,” in a previous interview with ISRAEL21c.
The Epitomee capsule incorporates polymers with opposing characteristics, absorbing stomach fluids and water, resulting in their separation and inflation. This process creates a temporary triangular device within the stomach, effectively deceiving the brain into perceiving fullness. After several hours, the triangular device disintegrates and exits the body through the digestive system.
In a US-based clinical trial involving 279 participants divided into two groups—one receiving the Epitomee pill and the other a placebo—the company observed noteworthy outcomes. Over a 24-week period, a majority of participants using the Epitomee pill experienced a weight loss ranging from 5 to 15 percent of their body weight, equating to approximately 10 to 30 pounds. Notably, the Epitomee group demonstrated significant weight loss within the initial four weeks, surpassing the control group.
Epitomee reported that 27 percent of participants taking their capsule shed at least 10% of their body weight, which is 2.5 times more than the control group. Additionally, over 10% of participants using the Epitomee pill achieved a weight loss exceeding 15% of their body weight.
Crucially, the company affirms the safety of its capsule, highlighting a complete absence of serious side effects during the trial. With regulatory approval secured in Israel and Europe, Epitomee is now gearing up to submit its application to the FDA, anticipating approval by 2024. The successful clinical trial positions Epitomee’s weight-loss solution as a promising development in the field of non-pharmaceutical interventions for weight management.
