BOSTON–(BUSINESS WIRE)–Gelesis, a biotechnology firm creating a novel hydrogel platform expertise to deal with chubby, weight problems and different power metabolic illnesses, publicizes the discharge of three poster displays at ObesityWeek® 2020, the annual congress of The Weight problems Society, together with:
- For the primary time, to the authors’ data, new information exhibits that impaired beta cell perform was related to a dysfunctional intestine barrier, a possible precursor to metabolic illness;
- Put up-hoc evaluation, using a novel statistical method, of Gelesis’ pivotal GLOW examine suggests a connection between weight reduction and glycemic biomarkers; and
- An examination of the interplay between a wide range of drinks and Plenity, an oral, non-systemic remedy cleared by the FDA as an assist for weight administration in adults with a BMI of 25–40 kg/m2, when used along side weight loss program and train.
“This work introduced at ObesityWeek highlights the interaction between the lack of intestinal barrier integrity and early beta-cell perform, including to the elevated focus of the gut-pancreatic axis and its important position on metabolic well being,” mentioned Paresh Dandona, MD, PhD, Distinguished Professor within the Division of Medication, Jacobs College of Medication and Biomedical Sciences at SUNY Buffalo. “Gelesis is main the sector of analysis for intestinal barrier well being with its hydrogel expertise, with the objective of turning into a frontline remedy method that targets the advanced gut-host interplay.”
The main points of the displays are as follows.
Poster Presentation (EP-234): Impaired Beta Cell Operate is Related to Proof of Dysfunctional Intestine Barrier; Husam Ghanim, PhD; State College of New York, Buffalo, NY
Impaired small intestinal permeability has been linked to metabolic illnesses, together with weight problems, diabetes, and fatty liver illness. Intestinal permeability will be measured by ingesting an answer containing varied sugars which are usually too massive to be absorbed via the intestine barrier. The presence of those sugars (e.g. cellobiose) within the urine recommend an impairment in intestine barrier perform. This evaluation is the primary, to the authors’ data, to explain an affiliation between elevated small gut permeability and a discount in insulin-secreting pancreatic beta-cell perform, as indicated by a decreased insulin response to a glucose stimulus. Diabetes is already recognized to have an affiliation with impaired intestine barrier. This new analysis additionally urged a correlation between fasting plasma glucose (FPG) and intestine permeability, proposing that pre-diabetes is doubtlessly related to impaired intestine barrier as properly. These information additionally recommend that intestinal barrier integrity could play an vital position within the remedy of metabolic illnesses.
Poster Presentation (EP-174): Evaluating Glucose and Insulin as Predictors of Weight Loss in GLOW: A Novel Statistical Strategy; Mads Fiil Hjorth, PhD; College of Copenhagen, Frederiksberg, Denmark
On this post-hoc evaluation of the Gelesis Lack of Weight (GLOW) examine, researchers evaluated fasting plasma glucose (FPG) and fasting plasma insulin (FPI) ranges as biomarker predictors for weight reduction with Plenity. The outcomes of this evaluation recommend that for every 1mg/dL enhance in FPG, individuals utilizing Plenity misplaced 0.10kg extra weight than these on placebo. Comparable associations to weight reduction had been noticed for fasting FPI and HOMA-IR for these people with elevated FPG. The authors conclude that FPG could also be a predictor of weight reduction with Plenity remedy, and FPI can also be an efficient predictor, significantly in sufferers with an elevated FPG. The outcomes of this evaluation are in step with the beforehand reported evaluation of the FLOW pilot examine, in addition to research which have demonstrated that sufferers with impaired FPG misplaced extra weight than these with regular glycemia when uncovered to diets larger in greens, fruits, and entire grains.
Poster Presentation (EP-175): Evaluating the Interplay of an Oral Superabsorbent Hydrogel with Alcohol and Acidic Drinks; Damian Bialonczyk, PharmD; Gelesis, Inc., Boston, MA
This presentation particulars the interplay of Plenity and the consumption of alcohol and acidic drinks throughout meals. Plenity is meant to be taken with 16 ounces of water 20-Half-hour previous to lunch and dinner. Nevertheless, some sufferers could elect to eat drinks aside from water with their meals (after consuming the beneficial 16 oz of water with their Plenity capsules earlier than the meal). The outcomes of this in-vitro evaluation recommend that the Plenity hydrogel maintains its firmness and water absorption capability within the presence of a meal and varied alcoholic and acidic drinks.
In regards to the Gelesis Loss Of Weight (GLOW) scientific examine
The Gelesis Loss Of Weight (GLOW) Research was a randomized, double-blind, placebo-controlled, parallel-group examine enrolling 436 adults with a physique mass index (BMI) ≥ 27 and ≤ 40 kg/m2, together with these with prediabetes or kind 2 diabetes. The 6-month examine in contrast a 2.25 g dose of Plenity, administered twice every day, to placebo and was carried out at 33 websites throughout the USA and several other European nations. Each the energetic and placebo arms additionally included a decreased calorie weight loss program and every day bodily exercise. The examine had two predefined co-primary endpoints: no less than 35% of sufferers taking Plenity reaching ≥ 5% weight reduction (categorical endpoint) and placebo-adjusted weight reduction with a super-superiority margin of three%. As well as, a prespecified evaluation of easy superiority was additionally carried out. The examine met and exceeded the predefined categorical endpoint, with 59% of adults within the remedy group reaching weight lack of 5% or higher. The examine didn’t meet the three% super-superiority endpoint however demonstrated superiority of the Plenity remedy over the placebo group (–6.4% vs. –4.4%, P=0.0007). Plenity-treated people had twice the percentages of reaching no less than 5% weight reduction vs. placebo (adjusted odds ratio [OR]: 2.0,P=0.0008). As well as, 26% of the adults who accomplished the remedy with Plenity had been “super-responders,” outlined as reaching no less than 10% weight reduction. These super-responders achieved a median of about 14% weight reduction or roughly 30 kilos. The general incidence of opposed occasions (AEs) within the Plenity remedy group was no completely different from placebo. The commonest treatment-related opposed occasions (TRAEs) had been gastrointestinal problems (158 TRAEs in 84 [38%] topics within the Plenity arm, in comparison with 105 occasions in 58 [28%] topics receiving placebo), infections and infestations (2 occasions in 2 [1%] topics with Plenity and 1 occasions in 1 [1%] topics with placebo), and musculoskeletal and connective tissue problems (3 occasions in 2 [1%] topics with Plenity and 0 in 0 [0%] topics with placebo). There have been no critical opposed occasions (SAE) within the Plenity remedy group, whereas there was one (1) SAE within the placebo remedy group.
Plenity is an oral, non-systemic, superabsorbent hydrogel which has obtained FDA clearance as an assist in weight administration in chubby and overweight adults with a BMI of 25–40 kg/m2, when used along side weight loss program and train. Gelesis has additionally obtained approval to market Plenity within the European Financial Space. Plenity is made by cross-linking two naturally derived constructing blocks, modified cellulose and citric acid, that create a three-dimensional matrix. Plenity particles quickly soak up water within the abdomen and homogenously combine with ingested meals. Moderately than forming one massive mass, it creates hundreds of small particular person gel items with the elasticity and firmness of stable plant-based meals (e.g., greens) with out caloric worth. The Plenity hydrogel will increase the amount and elasticity of the abdomen and small gut contents and induces a sense of fullness and satiety. As soon as it arrives within the massive gut, the hydrogel is partially damaged down by enzymes and loses its three-dimensional construction together with most of its absorption capability. The launched water is reabsorbed within the massive gut, and the remaining cellulosic materials is eradicated via the physique’s pure digestive processes. Plenity is taken into account a medical system as a result of it achieves its main supposed goal via mechanical modes of motion in step with mechanobiology constructs. For extra info, go to myplenity.com.
Vital Security Info
- Plenity is contraindicated in sufferers who’re pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide
- Plenity could alter the absorption of medicines. Learn Sections 6 and eight.3 of the Directions for Use fastidiously
- Keep away from use in sufferers with: esophageal anatomic anomalies, together with webs, diverticuli, and rings; suspected strictures (resembling sufferers with Crohn’s illness); and problems from prior gastrointestinal (GI) surgical procedure that would have an effect on GI transit and motility
- Use with warning in sufferers with energetic gastrointestinal situations resembling gastro-esophageal reflux illness (GERD), ulcers, or heartburn
- The general incidence of AEs within the Plenity group was no completely different than the placebo group
- The commonest negative effects had been diarrhea, distended stomach, rare bowel actions, and flatulence.
Gelesis is creating a novel hydrogel platform expertise to deal with chubby and weight problems and power illnesses associated to the GI pathway. Gelesis’ proprietary method is designed to behave mechanically within the GI pathway to doubtlessly alter the course of sure power illnesses. In April 2019, Gelesis obtained FDA clearance for its lead product candidate, Plenity®, as an assist for weight administration in chubby and overweight adults with a Physique Mass Index (BMI) of 25-40 kg/m2, when used along side weight loss program and train. It was additionally granted a CE Mark, which permits Gelesis to market Plenity within the European Financial Space. Plenity is presently obtainable in restricted launch within the U.S. Moreover, Gelesis is creating further investigational candidates resembling Gelesis200, a hydrogel optimized for weight reduction and glycemic management in sufferers with kind 2 diabetes and prediabetes. Novel hydrogel mechanotherapeutics primarily based on the Gelesis platform expertise are additionally being superior in different GI inflammatory situations, resembling non-alcoholic steatohepatitis (NASH) and practical constipation. For extra info, go to gelesis.com or join with us on Twitter @GelesisInc.