PLENITY manufacturing facility will be the first factory to
commercially produce medical super-absorbent hydrogels synthesized from
naturally derived building blocks
Targeted U.S. launch of PLENITY expected in 2H 2019, with broader
U.S. availability by prescription in 2020
BOSTON–(BUSINESS WIRE)–Gelesis,
a biotechnology company at the forefront of developing
mechanobiology-based therapies to treat chronic diseases related to the
gastrointestinal (GI) system, today announced it has received a
non-dilutive $10.6 (€9.4) million grant to support the commercial
manufacturing facility of PLENITY™, the company’s first commercial
product, which was recently 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.
“Gelesis is moving rapidly to build out its supporting infrastructure
for the launch of PLENITY as a prescription therapy, and this support
from the Puglia Region and the European Community is a welcome
non-dilutive addition to our preparations,” said David Pass, chief
operating officer and head of commercial of Gelesis. “We are excited to
build the first commercial manufacturing facility in the world capable
of producing super absorbent hydrogels synthesized from naturally
derived building blocks, based on the Gelesis core proprietary
technology. This achievement is the result of many years of dedicated
effort by our multi-disciplinary engineering teams. We will continue to
invest in our manufacturing processes and capacity to meet demand for
both commercial and clinical supply across our portfolio of hydrogel
therapies in development for chronic disease.”
Gelesis’ proprietary hydrogels are orally administered and synthesized
from two naturally derived building blocks – modified cellulose
cross-linked with citric acid – that create a three-dimensional matrix
to achieve specific mechanical properties through the GI system.
The grant was provided by the Puglia Region, where Gelesis’ current
material science research & development and clinical supply
manufacturing is located. The grant is intended to support the
development of a new commercial-scale manufacturing facility in the
region. The grant uses funds provided by the European Community via the
Operative Program of the European Fund for Regional Development (FESR),
which supports small enterprises with research and
industrialization-integrated activity. This award marks the second grant
awarded from the Puglia region of Italy. In 2011, Gelesis was awarded a
$1 million grant to scale up its laboratory and manufacturing facility
near the town of Lecce in Italy. Gelesis expects significant growth of
its headcount as it continues its preparations for a targeted U.S.
launch in the second half of 2019, before broader U.S. availability by
prescription in 2020.
About PLENITY™
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 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 mass 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 expelled in
the feces. 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 AEs in the PLENITY group was no different
than 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
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 is preparing to
initiate a targeted U.S. launch of PLENITY in the second half of 2019
and anticipates PLENITY will be broadly available by prescription in the
U.S. in 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 through a pipeline in other
GI inflammatory conditions where gut barrier and gut permeability
potentially play a role, such as non-alcoholic steatohepatitis (NASH)
and inflammatory bowel disease (IBD).
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.
Contacts
Investors
Allison Mead Talbot
+1 617 651 3156
amt@puretechhealth.com
U.S. Media
Tom Donovan
+1 857 559 3397
tom@tenbridgecommunications.com