New devices to combat obesity, from three Boston-area firms
Like many people who struggle to lose weight, Dalila Bahi tried plenty of diets. And like many people who go on diets, she always regained what she lost. By her own account, the 27-year-old nurse loves sweets, from chocolate cake to cheesecake, and lives in one of the world’s most tempting cities for desserts: Lyon, France.
In February, with her weight up to 227 pounds, she decided to try something new. Bahi’s doctor gave her a large capsule developed by a Natick biotech startup. It contained a deflated balloon attached to a thin catheter. After she swallowed the pill, the doctor filled the polyurethane balloon with about 2½ cups of water, then pulled the catheter out of her mouth. It all took about half an hour.
The balloon sat in her stomach for over four months, curbing her appetite. When it collapsed in July, as it was designed to do — and left her body the old-fashioned way — she weighed 30 pounds less. So far, she said, she hasn’t regained it.
“I feel so much better,” she said in a phone interview. “This program will change lives.”
The Elipse Balloon, created by Allurion Technologies, is part of a new wave of medical devices that have been developed in Greater Boston to combat the worsening obesity epidemic. Two rival biotechs hope to win approval of capsules that swell into a blob of gel in the stomach and a sleeve-like plastic barrier surgically inserted over part of the small intestine to limit food absorption.
The race to market new weight loss treatments comes as US obesity levels have become “alarmingly high,” according to a study released last month. The National Institutes of Health defines obesity as a body mass index of 30 or higher.
Some 39.6 percent of adults and 18.5 percent of children are obese, the highest rates ever documented, said the recent annual report, “State of Obesity 2018: Better Policies for a Healthier America,” published by the Trust for America’s Health and the Robert Wood Johnson Foundation.
Seven states now have adult obesity rates at or surpassing 35 percent, according to data from the Centers for Disease Control and Prevention: Alabama, Arkansas, Iowa, Louisiana, Mississippi, Oklahoma, and West Virginia.
Only two states, Colorado and Hawaii, and the District of Columbia, have adult obesity rates less than 25 percent. Massachusetts’s rate is 25.9 percent, ranking it the 44th most obese state. Although that’s relatively good news, Massachusetts was one of only six states whose adult obesity rates rose from 2016 to 2017.
Dr. Shantanu Gaur, chief executive of Allurion, said he and Dr. Samuel Levy, a classmate he befriended in their second year of Harvard Medical School, founded Allurion, the privately held Natick company, in 2009 after they realized that obesity was the common denominator in many diseases they studied.
“No matter what we did as medical students, it always came back to obesity,” Gaur, 32, said. “No matter if we were learning about hip and joint disease, infertility, diabetes, 13 different types of cancer — it seemed to impact every discipline.”
The balloon was approved in 2016 for use in Europe and in the Middle East, where regulatory hurdles are lower than in the United States. Allurion has begun testing it on 400 patients in the United States, and Gaur hopes to get it approved by the Food and Drug Administration in 2020.
Many people, of course, control their weight with exercise and a balanced diet. But some are unable or unwilling to do that and turn to more radical interventions, particularly if excess weight causes other health problems such as diabetes and high blood pressure.
Bariatric surgery, which involves reducing the size of the stomach to limit how much food it can hold, has been around for more than 50 years and over time has become less invasive. Although often effective, it’s also expensive, can pose serious risks, and isn’t always covered by insurance.
Five prescription weight-loss drugs have been approved by the FDA. They work by decreasing appetite or increasing feelings of fullness. But they, too, can cause side effects, be costly, and often aren’t reimbursed, medical experts say.
Gastric balloons aren’t new, but traditionally they are inserted through the esophagus and into the stomach in an endoscopic procedure after the patient receives anesthesia. Allurion says the Elipse is the first “procedureless” balloon that can be swallowed when the patient is fully awake in a doctor’s office.
“A patient can do it on his lunch break,” said Gaur.
A 12-year-old Boston biotech, Gelesis hopes to soon win approval of a different device to help fill a patient’s stomach: the Gelesis100 capsule.
The capsule contains small gel particles synthesized from cellulose — the principal component of plants — and citric acid. A patient swallows six capsules a day with water: three at lunch and three at dinner.
The particles rapidly absorb water and expand to 100 times their original size, producing a pudding-like blob similar to chewed vegetables that makes the patient feel full. The particles break down in the colon and leave the body the same way as digested food.
The capsules have been studied in more than 450 patients in five clinical studies in the United States, Canada, and Europe. Nearly 60 percent of adults who received them lost 5 percent or more of their weight over six months, and 20 percent lost at least 10 percent of their weight.
“This is meaningful weight loss, even if it’s not a hundred pounds,” said Harry Leider, who joined the company, an affiliate of publicly traded PureTech Health, in June as chief medical officer. Leider previously spent five years as chief medical officer of the giant drugstore chain Walgreens. In addition, there were no serious side effects, said Leider, who hopes the FDA clears the capsule for use by July.
A third company, GI Dynamics, founded in 2003 in Boston, has developed a device to treat type 2 diabetes and promote weight loss. This technology focuses on the small intestine, not the stomach.
Called the EndoBarrier, the device is installed through an endoscopy in the first 2 feet of the small intestine and stays in place for a year. It diverts food past that part of the intestine but allows nutrients to be absorbed by the rest of the organ, which is typically another 18 feet long.
The device appears to change the molecular signaling from the gut to the rest of the body. That in turn alters hormone levels that affect hunger, the feeling of fullness, and insulin sensitivity.
Scott Schorer, who was brought in as chief executive of publicly traded GI Dynamics in 2016 after a series of regulatory setbacks and leadership problems, said the one thing that has never been in doubt is the effectiveness of the device.
The EndoBarrier produces a “dramatic reduction in blood sugar and a dramatic reduction in weight,” he said.
The company hopes to begin a late-stage clinical trial next year and seek FDA approval in 2023.
No decision has been made on how much these products would cost consumers in the United States or whether insurance would cover them. The Elipse typically costs a European patient the equivalent of $3,500 and is not covered by insurance, Gaur said.
One point that several obesity specialists agreed on is that no treatment will work for long unless patients also try to eat healthier and exercise.
Dr. Yannis Raftopoulos, a bariatric surgeon who is helping to run a clinical trial of the Elipse Balloon at Holyoke Medical Center in Holyoke, said that even patients who have surgery to shrink their stomachs will regain weight unless they change their lifestyle.
“They need to do their part,” he said.