It might look like a drug, but a new weight loss pill under development by a Wellesley, Massachusetts startup is actually a device in disguise.
Allurion Technologies has created what’s essentially an intragastric balloon — like the ones marketed overseas by Allergan (NYSE:AGN) and Reshape Medical — that fills up the stomach with the intention of inducing a feeling of satiety that would help overweight and obese patients eat less and lose weight. But the twist for Allurion is that its device isn’t inserted via endoscopy while the patient is under sedation — it’s condensed in the form of a capsule and swallowed by the patient along with a glass of water.
When the pill reaches the stomach, Allurion’s proprietary hydrogel technology goes to work and the device swells up to 200 times its starting mass, taking up room and exerting pressure on the walls of the stomach to create a feeling of fullness. In combination with diet and exercise, and under the supervision of a physician, the device could help overweight patients drop some extra pounds.
At least that’s what the company hopes — it has yet to test the technology in humans. But prototypes have been placed in four animals, and those studies will continue over the next several months leading up to a clinical trial intended to begin in Europe in the first half of 2013, said Allurion co-founder Samuel Levy.
There are still parts of the technology that need to be refined, like how it will be removed from the stomach. Levy said the company is working on two potential mechanisms for removal of the device after a period of a few months, both of which are noninvasive.
If the device can be placed and removed without the need for an endoscopist and a procedure that requires sedation, it will serve an unmet market need, he said. “Our goal in starting this company really was to focus on an intervention that could be administered simply and inexpensively such that it could really make an impact at large and not be so expensive that it was only available to a small subpopulation,” he explained.
Levy and a former Harvard Medical School classmate, Shantanu Gaur, founded Allurion in 2009 after being inspired by the CEO of an Israeli medical device firm they did consulting work for, who told them to make a list of unmet medical needs and try to change the world. Taking his words to heart, Levy and Gaur came up with the idea to target the world’s 1.4 billion overweight adult population. They connected with the director of Beth Israel Deaconess Medical Center’s Center for Interventional Endoscopy, Dr. Ram Chuttani, who became the company’s chief medical officer, and Jonathan Wecker, a former healthcare investor with Bain Capital who was also previously CEO of American Institute of Gastric Banding, who became Allurion’s CEO.
If the idea of a pill that swells up in the stomach sounds familiar, it’s because others have tried, or are trying, to show clinical results with similar technology. Boston-based Gelesis has raised more than $16 million in its quest to commercialize a hydrogel pill that swells in the stomach. In the spring of 2010, the company presented clinical trial data indicating that its product was safe and well-tolerated, and significantly increased the feeling of satiety between meals in obese patients. But it’s been more than a year since we’ve heard anything from the company. An Internet search also turned up an animal study published in 2007 of a similar device called Ullorex, linked to stealthy Obalon Therapeutics, who MedCity News wrote about in April. The challenge for these companies is proving in trials that the minimally invasive devices don’t just cause satiety, but also induce significant, sustainable weight loss.
In the path to commercialization, Allurion will follow its predecessors and go after CE Mark first, as regulatory agencies overseas have been keener on approving these types of devices for obesity than the U.S. Food and Drug Administration (since the product isn’t absorbed into the bloodstream, Allurion believes it can follow the device pathway for approval). While an FDA panel earlier this year recommended upping the ante for clinical results of risky medical devices to treat obesity, the regulatory agency has also shown some signs of warming up to new treatments by clearing expanded use of Allergan’s Lap-Band in less overweight patients last year and approving two new weight loss drugs this year.
So far, Allurion has propelled itself forward with a $750,000 loan from the Massachusetts Life Science Center and $1.7 million in capital raised from a tech-focused venture capitalist, some Harvard Medical School professors and a group of angel investors, Levy said.
“We’re still in the process of finalizing exactly what CE Mark we’re going to pursue and what length of treatment we think is most appropriate — part of that will be determined during clinical trials that we’re planning,” he added. “But given the noninvasive procedure and lower cost, we think that our device will cost substantially less than endoscopically placed balloons and it will be more feasible for patients to use our device multiple times.”
what if the pill is not properly digested and ends up in the esophagus or throat. How will it be removed.? How will food get past it and not block the airway from buildup or does the person have to go on a liquid diet similar to those after bypass surgery is done. How will it work for people with excessive acid reflux ?