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ObesityWeek 2019

Plenity data show twice as many patients achieved BMI<27

The study met and exceeded the predefined categorical endpoint, with 59% of adults in the treatment group achieving weight loss of 5% or greater

Gelesis, a biotechnology company developing a novel hydrogel platform technology to treat obesity and other chronic diseases related to the gastrointestinal (GI) tract, announced results of a post-hoc analysis from the Gelesis Loss of Weight (GLOW) clinical trial for participants achieving a BMI<27. These data showed that twice as many adults (11%) lost enough weight to achieve a BMI<27 when treated with Plenity (Gelesis100) compared with those treated with placebo (5%). The results were shared in an oral session at ObesityWeek 2019, the annual combined congress of the American Society for Metabolic and Bariatric Surgery and The Obesity Society.

Plenity is an oral, non-systemic, superabsorbent hydrogel that rapidly absorbs water in the stomach and mixes homogeneously with ingested foods to increase the volume and elasticity of the stomach and small intestine contents. Plenity is made by cross-linking two naturally derived building blocks, modified cellulose and citric acid, that create a three-dimensional matrix.

Plenity particles rapidly absorb water in the stomach and homogenously mix with ingested foods. Rather than forming one large mass, it creates thousands of small individual gel pieces with the elasticity (firmness) of solid plant-based foods (e.g., vegetables) without caloric value. The Plenity hydrogel increases the volume and elasticity of the stomach and small intestine contents and induces a feeling of fullness and satiety.

Once it arrives in the large intestine, the hydrogel is partially broken down by enzymes and loses its three-dimensional structure along with most of its absorption capacity. The released water is reabsorbed in the large intestine, and the remaining cellulosic material is eliminated through the body’s natural digestive processes. Plenity is considered a medical device because it achieves its primary intended purpose through mechanical modes of action consistent with mechanobiology constructs.

“In order to break the cycle of adult obesity and have a meaningful impact on both individual and population health, we should shift the treatment paradigm to prevent obesity by treating patients when they are overweight and before they meet the clinical definition of obesity,” said Dr Ken Fujioka, a weight loss expert, endocrinology researcher at Scripps Clinic and scientific advisor to Gelesis. “This subgroup analysis provides clear and compelling insight into the safety and efficacy of Plenity treatment in overweight patients with a lower-BMI, and in conjunction with the exciting results from the overall study, provide a strong rationale for Plenity as an early therapeutic intervention for adults with excess weight.”

During an oral presentation at ObesityWeek 2019, study investigators delivered data from a new subgroup analysis of the Glow study assessing the safety and efficacy of Plenity in study participants reaching a BMI<27. The mean BMI at baseline for this Plenity-treated subgroup was 29.9 +/- 1.56 SD. Within this subgroup, adults treated with Plenity, on average, lost 13.5% of their total body weight in approximately 100 days with the rate of weight loss tapering as participants approached a healthy BMI. After achieving a BMI<27, participants continued Plenity treatment for an average of 60 days. The overall safety and tolerability profile of Plenity within this group was no different from placebo.

The Gelesis Loss Of Weight (GLOW) Study was a randomised, double-blind, placebo-controlled, parallel-group study enrolling 436 adults with a BMI≥27 and ≤40, including those with pre-diabetes or type 2 diabetes. The six-month study compared a 2.25g dose of Plenity, administered twice daily, to placebo and was conducted at 33 sites across the US and several European countries. Both the active and placebo arms also included a hypocaloric diet and daily physical activity.

The study had two predefined co-primary endpoints: at least 35% of patients taking Plenity achieving ≥5% weight loss (categorical endpoint) and placebo-adjusted weight loss with a super-superiority margin of 3%. In addition, a prespecified analysis of simple superiority was also performed.

The study met and exceeded the predefined categorical endpoint, with 59% of adults in the treatment group achieving weight loss of 5% or greater. As previously announced, the study did not meet the 3% super-superiority endpoint but demonstrated superiority of the Plenity treatment over the placebo group (–6.4% vs. –4.4%, p=0.0007). Plenity-treated individuals had twice the odds of achieving at least 5% weight loss vs. placebo (p=0.0008).

In addition, 26% of the adults who completed the treatment with Plenity were ‘super-responders’, defined as achieving at least 10% weight loss. These super-responders achieved an average of about 14% weight loss or approximately 30 pounds.

The overall incidence of AEs in the Plenity treatment group was no different from placebo. The most common treatment-related adverse events (TRAEs) were gastrointestinal disorders (158 TRAEs in 84 [38%] subjects in the Plenity arm, compared to 105 events in 58 [28%] subjects receiving placebo), infections and infestations (two events in two [1%] subjects with Plenity and one events in one [1%] subjects with placebo) and musculoskeletal and connective tissue disorders (three events in two [1%] subjects with Plenity and 0 in 0 [0%] subjects with placebo). There were no serious adverse events (SAE) in the Plenity treatment group, whereas there was one SAE in the placebo treatment group.

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