May 22, 2015
Gelesis Presents Additional Data at European Congress on Obesity
Gelesis100 modified food selection of overweight and obese patients with high fasting glucose by significantly decreasing carbohydrate intake, resulting in more weight loss
BOSTON, Massachusetts, May 22, 2015: Gelesis, a clinical stage biotechnology company focused on the development of first-in-class products to induce weight loss and improve glycemic control, announced additional results from a three-month proof of concept study of one of its product candidates, Gelesis100. The results were presented at the 22nd European Congress on Obesity (ECO) in Prague, Czech Republic.
In the three-month study, Gelesis100, taken twice daily, demonstrated a statistically significant decrease in percent energy from carbohydrate intake, and a statistically significant increase in percent energy from protein intake, from baseline to the end of treatment in patients defined as having high fasting plasma glucose at baseline (>93 mg/dL, which was the median of all patients) when compared to placebo. Gelesis previously disclosed that, in the same study, Gelesis100 induced statistically significant weight loss, as well as improvement in glycemic control parameters, with a particularly dramatic effect in prediabetic patients, defined as those with baseline fasting blood glucose ≥100 mg/dL and <126 mg/dL.
Mean changes in percent energy from carbohydrate intake were decreases of 4.6% (p = 0.003) with Gelesis100 2.25 g and 2.9% (p = 0.043) with Gelesis100 3.75 g, in contrast with an increase of 4.7% with placebo. Mean changes in percent energy from protein intake were increases of 5.0% (p = 0.012) with Gelesis100 2.25 g, 5.6% (p = 0.045) with Gelesis100 3.75 g, and 2.5% with placebo.
The significant decrease in percent energy from carbohydrate following chronic administration of Gelesis100 in patients with high fasting plasma glucose at baseline aligns with the glucostatic theory of appetite control. According to this theory, an increase in blood glucose concentrations results in increased feelings of satiety, whereas a drop in blood glucose concentrations results in increased feelings of hunger. Hypoglycemia, or abnormally low blood glucose, and/or glucose instability (especially in patients with initial high fasting glucose) might induce excess caloric intake, with a particularly high percent of calories from carbohydrate, leading to subsequent weight gain. According to this hypothesis, by distributing the absorption of glucose over a longer period of time, Gelesis100 induces a reduction in carbohydrate consumption that leads to a more robust effect on body weight as well as glycemic control, especially in patients with prediabetes.
In addition, the shift to higher percent energy from protein observed in the Gelesis100 treatment arms may also contribute to greater weight loss because protein dose-dependently increases the feeling of satiety through post-meal increases in circulating satiety hormones such as GLP-1 and PYY, and also has a higher thermic effect of feeding, meaning more energy (calories) is expended during the digestion of protein.
“Increased energy intake and especially increased carbohydrate component of food, such as added sugars, are major drivers of the overweight and obesity epidemics,” said Arne Astrup, Head of the Department of Nutrition and Sport at the University of Copenhagen and study principal investigator. “The findings of this study may support the glucostatic theory of appetite control as an explanation for the substantial weight-loss results observed, particularly in prediabetic patients, in the FLOW study.”
Gelesis100 is an orally administered capsule containing small hydrogel particles designed to employ multiple mechanisms of action along the gastrointestinal (GI) tract to induce weight loss and improve glycemic control. The hydrogel particles are synthesized through Gelesis’ multi-step, proprietary process using starting materials which are considered Generally Recognized As Safe (GRAS) by the U.S. Food and Drug Administration (FDA) and commonly used in the food industry.
Gelesis100 capsules are taken with water prior to a meal, after which the hydrogel particles are released from the capsules in the stomach and rapidly absorb water, hydrating to approximately 100 times their original size. The hydrogel particles mix homogeneously with food and travel through the GI tract, inducing satiety and improving glycemic control. Once in the large intestine, the particles release most of the water, which is reabsorbed by the body. The microscopic degraded particles are then safely eliminated by the body in the same manner as food. Gelesis has completed its three-month proof of concept study, a 128-patient, randomized, double-blind, placebo-controlled, parallel-group, clinical trial for Gelesis100 that demonstrated statistically significant weight loss and improvement of glycemic control parameters in overweight and obese patients, including prediabetics. Gelesis has recently initiated a six-month proof of concept study, the GLOW study, to assess the effect of Gelesis100 on body weight and glycemic control.
Gelesis is a clinical stage biotechnology company focused on the development of novel therapies to induce weight loss and improve glycemic control in overweight and obese patients, including those with prediabetes and diabetes. Gelesis 100, one of the company’s product candidates and a first-in-class therapeutic, is currently being evaluated in the six-month proof of concept GLOW study. Gelesis is also developing Gelesis200, created from the same proprietary hydrogel technology platform as Gelesis100, as a product optimized to improve glycemic control in prediabetics and type 2 diabetics, who may or may not require weight loss. The Gelesis executive and advisory team includes leading experts in obesity and its related comorbidities, clinical research and development, and advanced biomaterials.