PureTech Founded Entity Gelesis Presents Findings on Plenity®-Induced Weight Loss at the American Association of Clinical Endocrinology (AACE) 2021 Annual Virtual Meeting
PureTech Founded Entity Gelesis Presents Findings on Plenity®-Induced Weight Loss at the
Analysis showed that treatment for weight management with Plenity resulted in NALFD Fibrosis Score Improvement
These data support further clinical investigation using
First patient to enroll in a clinical trial leveraging this platform technology for treatment of NASH/NAFLD later this year
Plenity is a non-systemic oral superabsorbent hydrogel (OSH) that is FDA-cleared to aid in weight management in adults with excess weight or obesity, Body Mass Index (BMI) of 25 to 40 kg/m², when used in conjunction with diet and exercise.
This retrospective analysis of
The data presented today support the rationale for conducting further trials to evaluate OSH for the treatment of metabolic-related liver diseases.
The full text of the announcement from
Post-Hoc Analysis Showed Plenity®-Induced Weight Loss Resulted in NALFD Fibrosis Score Improvement
NAFLD Fibrosis Score (NFS) was developed to predict the presence of significant fibrosis using common clinical and laboratory values
The findings were presented today at the
These data support further clinical investigation using
Plenity is a non-systemic oral superabsorbent hydrogel (OSH) that is FDA-cleared to aid in weight management in adults with excess weight or obesity, Body Mass Index (BMI) of 25 to 40 kg/m², when used in conjunction with diet and exercise.
This retrospective analysis of
NFS was calculated at baseline and at 6 months for 317 study participants who had all available data at both timepoints. At baseline, 53.6% of patients receiving Plenity and 53.7% receiving placebo had a moderate or high NFS. At 6 months, fewer patients had moderate or high NFS in the Plenity group (45.2), while there was no change in the placebo group. The absolute numerical change in score was compared between baseline and 6 months, and a statistically significant reduction was observed in NFS within the Plenity group (-.15; p=0.030), but not the placebo group (+0.02; p=0.824). The difference between groups was statistically significant (p=0.043).
"These data further emphasize the need to address pre-obesity with and without comorbidities. Liver health is not always considered with a weight management plan, and yet early intervention may help prevent patients from developing metabolic-related liver disease," said presenting author Dr. Christopher Still, DO, FACP, Medical Director for the
The data presented today support further trials of OSH treatment for metabolic-related liver diseases.
About
Our portfolio includes Plenity, an FDA-cleared product to aid in weight management, as well as potential therapies in development for type 2 diabetes, Non-alcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic Steatohepatitis (NASH), and Functional Constipation.
For more information, visit gelesis.com, or connect with us on Twitter @GelesisInc.
About the Gelesis Loss of Weight (GLOW) Clinical Study
The Gelesis Loss of Weight (GLOW) Study was a randomized, double-blind, placebo-controlled, parallel-group study enrolling 436 adults with a body mass index (BMI) ≥ 27 and ≤ 40 kg/m2, including those with prediabetes or type 2 diabetes. The 6-month study compared a 2.25 g dose of Plenity, administered twice daily, to placebo and was conducted at 33 sites across
About Plenity®
Plenity is FDA-cleared to aid in weight management in adults with excess weight or obesity, Body Mass Index (BMI) of 25 to 40 kg/m², when used in conjunction with diet and exercise. Plenity is designed to help you feel full while eating less.
The capsules are taken 20-30 minutes before lunch and dinner with 16 oz of water, acting locally in the GI tract to make you feel fuller. Using a novel biomimetic approach, its structure and properties were inspired by vegetables. Plenity is available now in a limited release, with broad commercial availability later in 2021.
Important Safety Information
· Patients who are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide should not take Plenity.
· To avoid impact on the absorption of medications:
o For all medications that should be taken with food, take them after starting a meal.
o For all medications that should be taken without food (on an empty stomach), continue taking on an empty stomach or as recommended by your physician.
· The overall incidence of side effects with Plenity was no different than placebo. The most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence.
· Contact a doctor right away if problems occur. If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor.
Rx Only. For the safe and proper use of Plenity or more information, talk to a healthcare professional, read the Patient Instructions for Use, or call 1-844-PLENITY.
For more information, visit myplenity.com.
For more information, visit www.puretechhealth.com or connect with us on Twitter @puretechh.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are or may be forward-looking statements, including statements that relate to the company's future prospects, developments, and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, expectations regarding the benefits expected from Plenity based on the analysis presented at AACE, expectations regarding
|
||||
|
Reach is a non-regulatory news service. By using this service an issuer is confirming that the information contained within this announcement is of a non-regulatory nature. Reach announcements are identified with an orange label and the word “Reach” in the source column of the News Explorer pages of London Stock Exchange’s website so that they are distinguished from the RNS
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the