Gelesis raised $22 million in equity financing to develop its weight loss capsule. Gelesis was founded by PureTech Ventures in 2006. Prior to this funding, the company had raised $42 million through five rounds.
Gelesis’ lead product candidate, Gelesis100, contains hydrogel which can rapidly absorb water and swell to 100 times their size in the stomach. After several hours, enzymes in the large intestine will break down those particles, enabling the polymer to release the absorbed water. The drug is designed to make obese patients feel more full after meals.
In June 2014, Gelesis presented results of a 12-week trial (FLOW study) at ICE/ENDO2014. In the intention-to-treat population, the efficacy was very modest, and it didn’t look like a game changer. The mean body weight changes from baseline to the end of treatment were -6.1%, -4.5%, and -4.1%, with Gelesis100 2.25 g, Gelesis100 3.75 g, and placebo, respectively. There was no difference between the high-dose group and the placebo.
In the trial, patients were required to drink 500 ml of water before lunch and dinner and were counseled to reduce their diet by 600 kcal/day below their daily requirements. Dropout rates were 5%, 24%, and 21%, with Gelesis100 2.25 g, Gelesis100 3.75 g, and placebo, respectively. In my opinion, lower dropout rate may explain the observed higher weight loss in the 2.25 g group.
Gelesis’ analysis revealed that the greatest weight loss occurred in prediabetic patients treated with Gelesis100 2.25 g. They lost an average of 10.9% of their body weight in three months. However, there were only 9 prediabetic patients in the 2.25 g group. Again, there was no difference between the high-dose group and the placebo.
In January 2015, Gelesis initiated a 6-month trial (GLOW study) to assess the effect of Gelesis100 in 168 obese patients including prediabetics and type 2 diabetics. The GLOW results are expected in 2016H1.