An Israeli startup that has developed a drug-free pill for moderate weight loss recently completed its clinical trial ahead of US FDA approval with success.
Caesarea-based Epitomee developed an ingestible pill that opens up in the stomach to apply pressure on the stomach wall and produce a feeling of satiety.
“That’s something that’s easy to say, but making it happen is very challenging,” Epitomee CEO Dr. Dan Hashimshony previously told ISRAEL21c.
The Epitomee capsule incorporates polymers with opposing characteristics inside the pill that absorb water and other liquids from the stomach, leading to their separation and inflation. This results in a triangular-shaped device that sits in the stomach, tricking the brain into thinking that the stomach is full.
After a few hours, the triangular device disintegrates and leaves the body through the digestive system.
The US-based experiment saw 279 participants split into two groups – one taking the Epitomee pill and another a placebo.
Within 24 weeks, the company notes, most of the participants taking the Epitomee pill lost between five and 15 percent of their body weight, translating to some 10 to 30 pounds. Furthermore, those ingesting the Epitomee pill lost significant weight within the first four weeks, earlier than those in the control group.
Twenty-seven percent of those taking the Epitomee capsule lost at least 10% of their body weight – 2.5 times more than the control group – and over 10% lost at least 15% of their body weight, the company adds.
The capsule’s safety, the company notes, was also proven decisively, with zero serious side effects resulting from the device.
The company is now preparing its submission to the FDA and expects to receive approval in 2024. It has already received regulatory approval in Israel and Europe.