Ingestible Shape-Shifting Capsule Prompts Weight Loss

A novel self-administered device induces weight loss and improves glycemic control in overweight and obese patients.

The Epitomee Medical (Caesarea; Israel) Epitomee capsule is a drug-free, ingestible capsule that contains a biodegradable shape-shifting gel scaffold, which mechanically resists peristaltic waves as they progress through the stomach wall after eating. Triggered by stomach pH level, the mechanical resistance stimulates mechanoreceptors that create a sense of satiety, stalling gastric emptying. The gel scaffold acts on the stomach tissue for a period of several hours before it dissolves, thus avoiding stomach adaptation.

The treatment, which is administered twice daily, is intended for overweight or slightly obese persons with a body mass index (BMI) of 25-35 kg/m2 who seeks effective and safe assistance in weight loss. In a recent phase 2 study involving 52 patients, the average excess body weight loss was -21.8%, average BMI declined from 33 to 31, and waist circumference was reduced by 4.41 cm. Moreover, 80% of those patients who were hypertensive became normalized at week 12, and in 53% of pre-diabetic patients, fasting glucose was reduced from 104 to 92 and HbA1C% was reduced from 6.03 to 5.6.

“This self-use concept of the Epitomee capsule could represent a new direction in the way we treat overweight and obesity and could be very encouraging to many of my patients,” said Professor Haim Shirin, MD, director of the Institute of Gastroenterology, Liver Diseases, and Nutrition at Assaf Harofeh Medical Center (Beer Yaakov; Israel), who presented the study at the IsraeLIVE Endoscopy International conference, held during October 2018 in Haifa (Israel). “We were happy to see that there were no serious treatment-related adverse events and that the treatment was well tolerated.”

“Our solution is unique, and the only one that can actually be scaled up to treat billions of people who can benefit from it. Our device can deliver a range of benefits that impact health, wellness and quality of life, from weight loss and glycemic control to body shaping and circumference reduction. We are now working on making it available to the relevant patients in the market,” said Dan Hashimshony, MD, CEO of Epitomee. “Thanks to this work we can now go further in our investigations and complete our advanced phase 2. This will bring the Capsule closer to people who seek a safe and simple clinical weight loss solution.”

Peristalsis is a radially symmetrical contraction and relaxation of muscles that propagate in a wave down a muscular tube, in an anterograde fashion. In much of the gastrointestinal (GI) tract, smooth muscle contracts in sequence to produce a peristaltic wave, which forces a bolus of food along it. Peristaltic movement is initiated by circular smooth muscles contracting behind the chewed material to prevent it from moving back into the mouth, followed by a contraction of longitudinal smooth muscles, which pushes the digested food forward.

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