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Gelesis100 study

Gelesis completes patient enrolment in the Gelesis100 study

Company also expands second product candidate Gelesis200, European LIGHT-UP study

Gelesis has completed treatment in the pivotal GLOW (Gelesis Loss Of Weight) Study, a study designed to assess the long-term efficacy and safety of lead product candidate Gelesis100 over a six-month period across a broad patient population.

The company has also enrolled its first European patient in the ongoing LIGHT-UP study with its second product candidate, Gelesis200, for weight loss and glycaemic control. The study will enrol individuals who are overweight or have obesity and also have prediabetes or metformin-treated type 2 diabetes at more than 30 sites across the US, Canada, and Europe.

“We are learning a remarkable amount about the potential positive impact on local inflammation and glycaemic parameters through our unique hydrogel system that is at the forefront of mechanobiology,” said Dr Elaine Chiquette, Pharm, EVP Head of Science, Gelesis. “This emerging field at the interface of biology and engineering focuses on how cells sense and respond to mechanical stimuli and is helping us to unlock insights into the gut-brain-inflammation axis.”

Gelesis product candidates are designed to employ multiple mechanisms of action that leverage mechanotransduction along the gastrointestinal (GI) tract to induce weight loss and improve glycaemic control. The hydrogel particles swell and shrink in different parts of the GI system, mix homogeneously with food, travel through the GI tract, and once in the large intestines, release most of the water, which is reabsorbed by the body (Figure 1). The small hydrogel particles are then safely eliminated by the body in the same manner as food.

Figure 1: The hydrogel particles swell and shrink in different parts of the GI system

Gelesis100 is a pivotal-stage product candidate for weight loss and glycaemic control, which has demonstrated statistically significant weight loss, reduced hunger, increased satiety and strong safety in previous clinical studies.

Gelesis200 is a second product candidate that has been engineered for rapid hydration with significantly higher elasticity to enhance glycaemic control and weight loss for patients who have pre-diabetes or type 2 diabetes.

A proof-of-concept clinical study with Gelesis200 (LIGHT-UP) has been initiated for weight loss and glycaemic control in people with prediabetes or type 2 diabetes. The results from this study are expected mid-2018.

Both Gelesis100 and Gelesis200 are orally-administered capsules containing small hydrogel particles made by cross-linking two naturally occurring food ingredients to generate novel compositions that are expected to be safe and well tolerated.

 “We’re pleased to have reached these two milestones for Gelesis as we continue to progress our platform technology and expand our pipeline,” said Dr Hassan Heshmati, Chief Medical Officer of Gelesis. “We’re also continuing to establish a body of data around our platform technology, as we explore additional GI-related conditions such as nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH), and inflammatory bowel disease (IBD).”

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