Over the past year, Gelesis has made the turn from concept to clinic, building up the first data for an anti-obesity pill made out of little particles that swell in the stomach, making a person feel full. With more trials looming, and a second product on the way, the bills are growing—and the Boston startup just raised some more cash to cover them.
Gelesis said this morning that it’s raised $22 million in equity financing, $4 million of which came from Gelesis backers trading $4 million of convertible promissory notes for stock. CEO Yishai Zohar said in a statement that the funds come from “new and existing investors,” though he didn’t name them. PureTech is Gelesis’s founding investment firm; in the past, the company has said its backers include the Pritzker/Vlock Family Office and some “senior leaders” in the pharmaceutical, biotech, and finance sectors. Prior to this funding, the company had raised $42 million through five separate rounds since its inception in 2006.
Gelesis will use the cash to fund the trial work for its lead product, known as Gelesis100, and bring a follow-up candidate, Gelesis200, into clinical testing as well. The company has already completed a three-month proof-of-concept study for Gelesis100 in overweight and obese patients; it started a randomized, placebo-controlled, six-month trial for 168 of those patients, along with Type 2 diabetics (which weren’t in the earlier study), in November. The main goal is 5 percent weight loss over the course of the study; Gelesis is also testing how its pill affects diabetics’ blood sugar levels.
On its website, the company says that this study may support a regulatory filing in Europe “and certain other jurisdictions.” That’s because Gelesis isn’t taking the typical development route for a drugmaker—Phase I, II, and III trials to support a regulatory filing. Rather, the company wants to get Gelesis100 approved as a medical device, not a drug, because it’s made of two (undisclosed) ingredients that are “generally recognized as safe” by the FDA, and passes completely through the body without getting absorbed.
The concept is to pack sugar-grain-sized particles of a superabsorbent polymer into capsules taken with a glass or two of water. Once in the stomach, those particles are released from the capsule, sponge up the water, and swell to a hundred times their size, tricking the body into feeling full. The particles also mix with food, keeping it in the stomach longer and slowing digestion. But enzymes in the large intestine break down those particles, release the water, and enable the polymer to exit the body with stool.
One proposed advantage here over other treatments is weight loss without the safety/tolerability issues—like diarrhea, dizziness, or dry mouth, among other side effects—since Gelesis100 isn’t absorbed into the bloodstream. That hasn’t been proven yet, however—at least for patients on a high dose of Gelesis100. In its first three-month study, in 128 non-diabetic, overweight and obese patients, a lower dose (2.25g) of Gelesis100 helped people lose, on average, 6.1 percent of their body weight, compared to 4.5 percent for a higher dose (3.75g) and 4.1 percent for those on placebo. Gelesis surmised that “lower tolerability” was to blame for the higher-dose results, citing gastrointestinal side effects in nine patients from that group who dropped out of the study. By comparison, the lower-dose group had even fewer side effects than those on placebo, Gelesis said at the time. It also noted that people with higher blood sugar levels lost more weight, part of the reason it’s now testing Gelesis100 in pre-diabetics and type 2 diabetics.
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