New Plenity™ Pivotal Safety and Efficacy Data to be Presented at ObesityWeek 2019
29 Octubre 2019 - 5:00AM
Business Wire
Gelesis, a biotechnology company developing a novel hydrogel
platform technology to treat obesity and other chronic diseases
related to the gastrointestinal (GI) tract, today announced that
the Company will deliver two oral presentations and one poster at
ObesityWeek 2019, the annual combined congress of the American
Society for Metabolic and Bariatric Surgery and The Obesity Society
in Las Vegas, Nevada, from November 3-7, 2019. The presentations
will detail data regarding the safety and efficacy of Plenity™
(Gelesis100), including a new subgroup analysis of patients
achieving a Body Mass Index (BMI) of at least 27 kg/m2 in the
company’s pivotal Gelesis Loss of Weight (GLOW) clinical trial.
Plenity is an oral, non-systemic therapeutic cleared by the FDA as
an aid for weight management in adults with a Body Mass Index (BMI)
of 25–40 kg/m2, when used in conjunction with diet and
exercise.
“More than half of the approximately 150 million adults in the
U.S. with a BMI ranging from 25 kg/m2 to 40 kg/m2 are classified as
overweight (BMI 25-30 kg/m2). Until now, many of them have not had
access to prescription treatment options,” commented Harry L.
Leider, MD, MBA, FACPE, Chief Medical Officer of Gelesis. “As the
only prescription weight management product cleared for use by
overweight adults with a BMI as low as 25 kg/m2, we are eager to
share new pivotal data which underscores the safety and efficacy of
Plenity in patients in the overweight range as well as the broader
range of obesity – up to a BMI of 35 kg/m2. This new data
highlights the unique opportunity Plenity creates to treat adults
struggling to achieve a healthy weight earlier than previously
possible with other prescription therapeutics.”
Details of the presentations are as follows:
Tuesday, November 5, 2019: 1:00 pm PT-3:00 pm PT, Drugs and
Devices - New Interventions, and New Perspectives on Trusted
Standbys
- Safety of Gelesis100 in Subjects Who Reached a Body Mass Index
Below 27 kg/m2 in the GLOW Study; Louis J. Aronne, MD, FACP,
Sanford I. Weill Professor of Metabolic Research, Weill-Cornell
Medical College
- Safety of Gelesis100 in Overweight or Obesity: Comprehensive
Analysis of the GLOW Study; Ken Fujioka, MD, Director of the
Nutrition and Metabolic Research Center and the Center for Weight
Management, Scripps Clinic
Thursday, November 7, 2019: 12:00 pm ET-1:30 pm PT, poster
presentation
- Assessment of Early Intervention with Gelesis100 in Overweight
and Mild Obesity in the GLOW Study; Frank L. Greenway, MD, Medical
Director and Professor at the Pennington Biomedical Research
Center, Louisiana State University System (T-P-3542)
About Plenity™ (Gelesis100) Plenity is an oral,
non-systemic, superabsorbent hydrogel which has received FDA
clearance as an aid in weight management in adults with overweight
and obesity with a BMI of 25–40 kg/m2, when used in conjunction
with diet and exercise. It is made by cross-linking two naturally
derived building blocks, modified cellulose and citric acid, that
create a three-dimensional matrix. Plenity particles rapidly absorb
water in the stomach and homogenously mix with ingested foods.
Rather than forming one large mass, it creates thousands of small
individual gel pieces with the elasticity (firmness) of solid
plant-based foods (e.g., vegetables) without caloric value. The
Plenity hydrogel increases the volume and elasticity of the stomach
and small intestine contents and induces a feeling of fullness and
satiety. Once it arrives in the large intestine, the hydrogel is
partially broken down by enzymes and loses its three-dimensional
structure along with most of its absorption capacity. The released
water is reabsorbed in the large intestine, and the remaining
cellulosic material is eliminated through the body’s natural
digestive processes. Plenity is considered a medical device because
it achieves its primary intended purpose through mechanical modes
of action consistent with mechanobiology constructs. For more
information, visit myplenity.com.
Important Safety Information
- Plenity is contraindicated in patients who are pregnant or are
allergic to cellulose, citric acid, sodium stearyl fumarate,
gelatin or titanium oxide.
- Plenity may alter the absorption of medications. Read Sections
6 and 8.3 of the Instructions for Use carefully.
- Avoid use in patients with the following conditions: esophageal
anatomic anomalies, including webs, diverticuli, and rings;
suspected strictures (such as patients with Crohn’s disease); or
complications from prior gastrointestinal (GI) surgery that could
affect GI transit and motility.
- Use with caution in patients with active GI conditions such as
gastro-esophageal reflux disease (GERD), ulcers or heartburn.
- Overall, the most common treatment-related adverse events
(TRAEs) were GI-related, with 38% of adults in the Plenity group
and 28% of adults in the placebo group.
- The overall incidence of adverse events (AEs) in the Plenity
group was no different from the placebo group.
Rx Only. For the safe and proper use of Plenity, refer to the
Instructions for Use.
About Gelesis Gelesis is developing a novel hydrogel
platform technology to treat overweight and obesity and chronic
diseases related to the GI pathway. Gelesis’ proprietary approach
is designed to act mechanically in the GI pathway to potentially
alter the course of certain chronic diseases. In April 2019,
Gelesis received FDA clearance for its lead product candidate,
Plenity™, as an aid for weight management in overweight and obese
adults with a Body Mass Index (BMI) of 25-40 kg/m2, when used in
conjunction with diet and exercise. Gelesis anticipates Plenity
will be broadly available by prescription in the U.S. in late 2020.
Additionally, Gelesis is developing its second investigational
candidate, Gelesis200, a hydrogel optimized for weight loss and
glycemic control in patients with type 2 diabetes and prediabetes.
Novel hydrogel mechanotherapeutics based on the Gelesis platform
technology are also being advanced in other GI inflammatory
conditions, such as non-alcoholic steatohepatitis (NASH) and
Chronic Idiopathic Constipation (CIC).
The Gelesis executive and advisory team includes some of the
world’s leading experts in obesity, materials science, chronic
disease research, and commercialization. Gelesis was co-founded by
PureTech Health (LSE: PRTC), a biopharmaceutical company focused on
the Brain-Immune-Gut (BIG) axis. For more information, visit
gelesis.com or connect with us on Twitter @GelesisInc.
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Allison Mead Talbot +1 617 651 3156 amt@puretechhealth.com
Puretech Health (LSE:PRTC)
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