Obesity Capsule From Gelesis, Made to Swell Up in the Stomach, Passes First Human Trial

Luke Timmerman4/22/10Follow @ldtimmerman

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2 grams of the Gelesis product in five oral tablets, with a glass of water before breakfast, lunch, and dinner. They were asked to fill out a questionnaire immediately after their meal, 30 minutes later, and an hour afterward.

The people reported that they felt an increasing sense of fullness (known formally as satiety) after each meal, and that when it was taken before lunch, people felt significantly less hungry at dinnertime. The feeling of hunger didn’t completely go away between breakfast and lunchtime, researchers posited, because people didn’t eat as much at breakfast to fill up their stomach and get the full benefit of the hydrogel.

The treatment was safe and well-tolerated, researchers said. About 16 percent of the people studied reported at least one symptom across the treatment and placebo group. About 7 percent reported nausea, about 4 percent complained of constipation or stomach ache, while just one person reported diarrhea. The incidence of side effects was similar to what overweight people often experience in placebo groups of similar trials.

Of course, this was just the first clinical trial for Gelesis, so it wasn’t really designed to measure the treatment’s effectiveness. Any treatment for weight loss is going to have to show it can help people lose weight over a yearlong period, according to the FDA’s current guidelines for obesity drugmakers. And that treatment aspires to help people who are moderately overweight—not the morbidly obese. Since overweight people have a less severe condition, the FDA is going to want to ensure any new therapy has a very clean safety profile. And there is at least one well-financed competitor, Lexington, MA-based GI Dynamics, which is also pursuing the promise of a device that’s a less-invasive alternative to gastric bypass surgery.

The Gelesis team knows all that, and is thinking hard about the next steps. The company has some government grants and partners providing non-dilutive sources of capital, and it is in strong enough financial shape that it doesn’t need to raise another venture round anytime soon, Zohar says. The company is considering the next steps in clinical development.

But these sound like heady times at Gelesis. The co-inventor, Sannino, said he has tried the product out himself, outside of the rigorous setting of a clinical trial. A few of the Gelesis investors have too, just, I suppose, as part of doing thorough due diligence. “It is quite surprising how you feel,” Sannino says. “It was like having eaten a plate full of spaghetti.”

Luke Timmerman is the National Biotech Editor of Xconomy. E-mail him at ltimmerman@xconomy.com Follow @ldtimmerman