Gelesis has been radio silent for a few years after splashing onto the scene with an anti-obesity pill made out of little particles that swell in the stomach, making a person feel full. Today, the Boston-based startup is reemerging with a new round of cash and plans to reveal data soon that will finally show just what kind of weight loss the treatment can provide.
Gelesis has put together a new $12 million financing round from founding investment firm PureTech, the Pritzker/Vlock Family Office and a group of unspecified “senior leaders” in the pharmaceutical, biotech, and finance sectors. Rob Armstrong, Eli Lilly’s former vice president of global external R&D (and an entrepreneur-in-residence at PureTech), has also come aboard as Gelesis’ chief business officer. Gelesis has now raised a total of $42 million through five rounds since its inception, according to CEO Yishai Zohar.
Gelesis is grabbing the cash at a pivotal time. To date, the company has only done a clinical study showing that its treatment, Gelesis100, can make humans feel more full after meals and less hungry in between. But next month, it will reveal data from a clinical trial comparing the weight loss effects of the pill to a placebo, according to Zohar. That will mark the first time Gelesis will show hard data about its treatment’s safety and effectiveness and give an indication how it stacks up against competitors in a crowded field. The results of the trial will also guide a further study, according to Armstrong—Gelesis will pick out the subgroup of people who respond the best and gear the next trial towards them. The new cash will partly go towards that effort.
For those unfamiliar, Gelesis started up in 2006 based around technology out of the University of Saliento in Italy. The company packs sugar-grain-sized particles of a superabsorbent polymer into capsules designed to be taken with a glass or two of water. Inside the stomach, the particles are released from the capsule and sponge up the water, swelling to a hundred times their original size. The resulting pressure on the stomach’s walls sends signals to the brain that the stomach is full. The particles also mix with food, keeping it in the stomach longer and slowing the absorption of nutrients in the small intestine, Gelesis says. Enzymes in the large intestine break the particles down, releasing the water and allowing the polymer to pass out with the rest of the stool.
The concept of fooling the stomach into thinking it’s full isn’t novel—chia seeds and natural supplements like the seaweed pill Appesat similarly purport to work by expanding in the stomach, and some models are even known to eat tissue paper for the same type of effect. But Zohar says that Gelesis’s product is more effective than the ones made with natural fibers and, because it is made out of two components listed by the FDA as “generally recognized as safe” for use in foods, safer than competing synthetic polymers that are made with “highly toxic” materials.
Meanwhile, because Gelesis100 isn’t absorbed into the bloodstream, it should avoid the risks associated with other weight loss drugs, Zohar says. Diarrhea is one of the side effects commonly associated with orlistat (Xenical by prescription, Alli at a reduced dose over-the-counter), for instance, while branded weight loss pills phentermine/topiramate (Qsymia, sold by Vivus) and lorcaserin (Belviq, Arena Pharmaceuticals) can potentially cause dizziness, dry mouth, and constipation.
These safety and efficacy advantages are the type of thing Gelesis is hoping to prove in the trial it’s preparing to publish next month. Zohar wouldn’t reveal much about the study itself, or the side effects experienced by patients in the trial, only that the company is “very pleased” with the safety the treatment has shown.
Once Gelesis releases those study results, another, larger one will follow. Ultimately Gelesis is looking to get the treatment approved as a medical device, rather than as a drug, since it passes completely through the body. Gelesis has met with the FDA to discuss what would be required for approval, but the company isn’t disclosing what else it would have to do, other than to say another study is coming that will be populated by some of the types of responders in the current study. Gelesis may foot the bill all the way through that study and on to potential FDA approval, but the company is open to a partnership as well, Armstrong says.
Of course, there are many hurdles ahead for Gelesis. First is accruing the statistical proof that its product helps people lose weight, while backing up the company’s claims of a superior side effect profile. Then there’s not only winning FDA approval of the product, but successfully selling it. While there’s a huge potential market for obesity drugs, recently approved pills like Vivus’ phentermine/topiramate and Arena’s lorcaserin have been a commercial disappointment so far. And Big Pharma has tended to shy away from obesity drugs since the fen-phen debacle in the late 90s, when a fenfluramine/phentermine combo drug sold by Wyeth that was linked to damaged heart valves, leading to billions in legal liability.
For healthcare providers, “I think there’s a lot of concern around the balance of [safety and efficacy], I think that’s why that market has been a little bit slow on the uptake,” Armstrong says. “The challenge for us, that I think we can meet, is that we have a combination of those two parameters.”
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