Plenity-treated adults achieving a BMI of
<27 lost an average of 13.5% of
their weight with the rate of weight loss tapering as participants
approached a healthy BMI goal
Twice as many adults reached a BMI of 27 or
less when treated with Plenity compared to placebo
No increased safety risk observed in lower BMI
adults (<35), with the overall
incidence of treatment-related adverse events no different from
placebo
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 results
of a new post-hoc analysis from the Gelesis Loss of Weight (GLOW)
clinical trial for participants achieving a Body Mass Index (BMI)
of 27 kg/m2 or less. These data showed that twice as many adults
(11%) lost enough weight to achieve a BMI of 27 or less when
treated with PlenityTM (Gelesis100) than when treated with placebo
(5%). Plenity is an oral, non-systemic, superabsorbent hydrogel
that rapidly absorbs water in the stomach and mixes homogeneously
with ingested foods to increase the volume and elasticity of the
stomach and small intestine contents. Consistent with the larger
GLOW cohort, the overall incidence of adverse events (AEs) in
lower-BMI adults treated with Plenity was no different from placebo
treatment. The results were shared in an oral session at
ObesityWeek 2019, the annual combined congress of the American
Society for Metabolic and Bariatric Surgery and The Obesity
Society.
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America's Weight Crisis: Tipping the
Scale in Favor of Early Action (Graphic: Business Wire)
Less than half of the approximately 150 million adults in the
U.S. struggling with overweight and obesity (BMI 25 kg/m2 to 40
kg/m2) meet the clinical threshold for obesity (BMI > 30 kg/m2).
Yet the health burden of excess weight begins before the onset of
obesity, with approximately 40% of BMI-related deaths in 2015
occurring in overweight adults with a BMI <30 kg/m2. Studies
show even modest weight gain in early adulthood is strongly
associated with critical outcomes such as cancer risk and
mortality.
“In order to break the cycle of adult obesity and have a
meaningful impact on both individual and population health, we
should shift the treatment paradigm to prevent obesity by treating
patients when they are overweight and before they meet the clinical
definition of obesity,” said Ken Fujioka, M.D., a weight loss
expert, endocrinology researcher at Scripps Clinic and scientific
advisor to Gelesis. “This subgroup analysis provides clear and
compelling insight into the safety and efficacy of Plenity
treatment in overweight patients with a lower-BMI, and – in
conjunction with the exciting results from the overall study –
provide a strong rationale for Plenity as an early therapeutic
intervention for adults with excess weight.”
During an oral presentation at ObesityWeek 2019, study
investigators delivered data from a new subgroup analysis of the
Glow study assessing the safety and efficacy of Plenity in study
participants reaching a BMI of <27
kg/m2. The mean BMI at baseline for this Plenity-treated subgroup
was 29.9 +/- 1.56 SD. Within this subgroup, adults treated with
Plenity, on average, lost 13.5% of their total body weight in
approximately 100 days with the rate of weight loss tapering as
participants approached a healthy BMI. After achieving a BMI of
<27 kg/m2, participants continued
Plenity treatment for an average of 60 days. The overall safety and
tolerability profile of Plenity within this group was no different
from placebo.
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 the United States and several European
countries. Both the active and placebo arms also included a
hypocaloric diet and daily physical activity.
The study had two predefined co-primary endpoints: at least 35%
of patients taking Plenity achieving ≥ 5% weight loss (categorical
endpoint) and placebo-adjusted weight loss with a super-superiority
margin of 3%. In addition, a prespecified analysis of simple
superiority was also performed. The study met and exceeded the
predefined categorical endpoint, with 59% of adults in the
treatment group achieving weight loss of 5% or greater. As
previously announced, the study did not meet the 3%
super-superiority endpoint but demonstrated superiority of the
Plenity treatment over the placebo group (–6.4% vs. –4.4%,
P=0.0007). Plenity-treated individuals had twice the odds of
achieving at least 5% weight loss vs. placebo (adjusted odds ratio
[OR]: 2.0, P=0.0008).
In addition, 26% of the adults who completed the treatment with
Plenity were “super-responders,” defined as achieving at least 10%
weight loss. These super-responders achieved an average of about
14% weight loss or approximately 30 pounds.
The overall incidence of adverse events (AEs) in the Plenity
treatment group was no different from placebo. The most common
treatment-related adverse events (TRAEs) were gastrointestinal
disorders (158 TRAEs in 84 [38%] subjects in the Plenity arm,
compared to 105 events in 58 [28%] subjects receiving placebo),
infections and infestations (2 events in 2 [1%] subjects with
Plenity and 1 events in 1 [1%] subjects with placebo), and
musculoskeletal and connective tissue disorders (3 events in 2 [1%]
subjects with Plenity and 0 in 0 [0%] subjects with placebo). There
were no serious adverse events (SAE) in the Plenity treatment
group, whereas there was one (1) SAE in the placebo treatment
group.
About Plenity™ (Gelesis100) Plenity is an oral,
non-systemic, superabsorbent hydrogel which has received FDA
clearance as an aid in weight management in overweight and obese
adults with a BMI of 25–40 kg/m2, when used in conjunction with
diet and exercise. It is the only prescription therapeutic cleared
by the FDA for use in overweight adults with a BMI below 30 kg/m2,
with or without comorbidities such as hypertension, type 2
diabetes, and dyslipidemia. Plenity 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 available by prescription in the U.S. in the second half of
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 clinical-stage biotechnology company
dedicated to discovering, developing and commercializing highly
differentiated medicines for devastating diseases. For more
information, visit gelesis.com or connect with us on Twitter
@GelesisInc.
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version on businesswire.com: https://www.businesswire.com/news/home/20191105005262/en/
Allison Mead Talbot +1 617 651 3156 amt@puretechhealth.com
Puretech Health (LSE:PRTC)
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