Gelesis Holdings Inc. announced that it released a poster presentation at the International Congress of Endocrinology in Singapore. The LIGHT-UP study evaluated the safety and efficacy of GS200, an investigational oral hydrogel, which was designed to emulate the properties of ingested raw vegetables, with slightly different mechanical properties compared to Plenity (GS100). The LIGHT-UP study was conducted over 25 weeks in 254 participants with prediabetes or type 2 diabetes and a BMI of 27-40 kg/m2.

It met its primary endpoints and GS200 reported a highly favorable categorial weight loss response and tolerability in a population that often struggles to lose weight and is at high risk for obesity-related complications. One out of three GS200-treated adults were “super responders,” losing at least 10% of their body weight and on average losing 13% (30 pounds), or 7 inches off their waist circumference in only 25 weeks. The study also investigated meal-time insulin release in people with prediabetes using a two-hour oral glucose tolerance test.

Participants with prediabetes treated with GS200 had significantly less total mealtime insulin release, compared to placebo, the mean difference was -22.0%, P=0.04. The peak level of mealtime insulin was also significantly lower for people that used GS200 when compared to placebo with a mean difference of 47.3µU/mL, P=0.03. The multicenter, double-blind, randomized, placebo-controlled study enrolled 254 subjects and was designed to assess the change in body weight in adults with overweight or obesity, who have prediabetes or diabetes, after 25 weeks of treatment with a new oral superabsorbent hydrogel (GS200) or placebo.

The study met both of its primary endpoints: the proportion of participants who achieved at least 5% body weight loss and the change in body weight after six months of therapy. A highly binary effect was observed with the GS200 treatment group, with a clear separation between responders and non-responders as early as after 6 weeks of treatment. Among the adults who completed the study protocol requirements (PP population), 64% of GS200-treated adults were Responders vs.

41% in the placebo group (p=0.001). In the analysis which also included data from the participants who didn't fully complete the study (ITT-MI), 55% of GS200-treated adults were Responders vs. 34% in the placebo group (p=0.0004).

The average body weight loss of the Responders was 11% (approximately 23 pounds) and their waist circumference was reduced by 5.5 inches on average. Importantly, Gelesis treated individuals had 2.8 higher odds compared with placebo to become Responders (adjusted odds ratio = 2.83, P=0.0004), achieving the first primary endpoint of the study. With respect to average total weight loss, the complete GS200 treatment group (including both Responders and Non-Responders) demonstrated superiority over placebo after 25 weeks of treatment (body weight loss of 7.1% vs.

4.6%, P=0.0029 in the PP population or 6.9% vs. 4.3%, P=0.0011 in the ITT population), thereby achieving the second primary endpoint. GS200 demonstrated a highly favorable safety and tolerability profile as the overall incidence of adverse events (AEs) in adults treated with GSP200 was similar to the incidence of AEs in the placebo group.