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In early-stage study data presented Monday at a joint meeting of the International Congress of Endocrinology and The Endocrine Society(ICE/ENDO), Gelesis reported that its oral capsulated device Gelesis100 led to significant weight loss in overweight and obese subjects, with "particularly dramatic" results seen in people with pre-diabetes. Lead investigator Arne Astrup said the therapy, which consists of thousands of particles of a superabsorbent biocompatible hydrogel, "represents an entirely new approach to treating obesity," and that the findings suggest Gelesis100 may be able to provide a weight-loss alternative "that does not involve surgery, injections, or systemically absorbed drugs."
The FLOW study assessed the effect of chronic oral administration of Gelesis100 on 128 non-diabetic patients who were overweight or obese. The participants, who had a mean body mass index of 31.7, were randomised to receive placebo or twice-daily treatment with one of two doses of Gelesis100. The company said at least one post-baseline weight assessment was conducted in the 125 people making up the intention-to-treat population.
Results at 12 weeks showed that the mean body weight percent changes from baseline for the lower- and higher-dose Gelesis100 arms were -6.1 and -4.5, respectively, versus -4.1 for the placebo group. The company noted that those given the lower-dose who had elevated fasting blood glucose before treatment lost 8.2 percent of their body weight. Gelesis reported that participants with pre-diabetes whose initial fasting blood glucose levels ranged from 100 mg/dL to 125.9 mg/dL achieved the greatest weight loss, losing an average of 10.9 percent of their body weight in three months. Further, researchers said they found a significant inverse correlation between fasting glucose at baseline and change in body weight in the lower-dose Gelesis100 arm.
Gelesis suggested "lower tolerability leading to reduced compliance may explain the…lower weight loss observed" in the higher-dose group. Dropout rates for the lower- and higher-dose Gelesis100 arms were 5 percent and 24 percent, respectively, versus 21 percent for placebo. The company noted that of the two dropouts in the lower-dose arm, neither reported side effects, while all of the nine dropouts treated with the higher-dose therapy did report side effects. Gelesis also pointed out that the placebo capsules used in the trial contained microcrystalline cellulose "with low water-absorption capacity and potential weight-loss properties."
Meanwhile, the company said conversion from an obese status at baseline to an overweight status at the end of the study occurred in 39 percent of the lower-dose Gelesis100 group, 24 percent of those in the higher-dose group and 17 percent of the placebo group. Conversions from overweight to normal-weight status occurred in 29 percent and 8 percent of participants in the lower- and higher-dose arms, respectively, while none were observed in the placebo group. Moreover, the company said 56 percent of people on lower-dose Gelesis100, 78 percent of subjects in the higher-dose group and 27 percent of those given placebo shifted from having pre-diabetes at baseline to a normal glucose status by the study's end.
CEO Yishai Zohar explained that Gelesis100 "is designed to increase the volume and elasticity of the stomach and small-intestine contents, delaying gastric emptying, and leading to longer post-meal satiety with subsequent weight loss." He added that, if approved, the product would be regulated as a medical device, "but is anticipated to be prescribed and administered like a drug." The company indicated that it would initiate a larger study next year aimed at winning approval for the product.
Last week, an FDA advisory panel voted in favour of recommending US approval for another obesity device, EnteroMedics' Maestro Rechargeable System, which is designed to control hunger and fullness through Vbloc neuroblocking technology.
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