Promising Clinical Data from Pilot Study of Gelesis’ Novel Hydrogel GS500 Prototype for the Potential Treatment of Chronic ...
19 Mayo 2019 - 11:30AM
Business Wire
Investigational candidate developed by Gelesis
demonstrated significant 16 hour reduction in colonic transit time
in patients with chronic idiopathic constipation
First clinical study demonstrating
super-absorbent hydrogel platform’s potential in this common
condition
Gelesis, a biotechnology company at the forefront of developing
mechanobiology-based therapies to treat chronic diseases related to
the gastrointestinal (GI) system, announced the presentation
of data from a clinical study demonstrating that GS500 prototype
(GS500/CSP01) provided a significant reduction in colonic transit
time (CTT) in patients with chronic idiopathic constipation (CIC)
relative to placebo. The data were presented at Digestive Disease
Week 2019, held in San Diego, California.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20190519005027/en/
The GS500 three-dimensional structure
generates an elastic response similar to vegetables and orders of
magnitude greater than fibers. (Graphic: Business Wire)
“One out of seven adults throughout the world suffer from
chronic idiopathic constipation. This condition can have a
significant negative impact on quality of life,” said Dr. Braden
Kuo, Gastrointestinal Unit in the Massachusetts General Hospital
(MGH) Department of Medicine. “The safety and efficacy results of
this study are intriguing and suggest further clinical evaluation
in this very common, treatment resistant condition would be both
warranted and welcome.”
Gelesis’ proprietary hydrogel product candidates are orally
administered and synthesized from two naturally derived building
blocks – modified cellulose cross-linked with citric acid – that
create a three-dimensional matrix designed to achieve specific
mechanical properties (high elastic response) through the
gastrointestinal system. In order to assess the potential
therapeutic benefits of the hydrogel’s specific mechanical
properties, modified cellulose, the main building block of GS500,
was included as an active control. This modified cellulose is a
widely used soluble dietary fiber but lacks the three dimensional
structure of the superabsorbent hydrogel, and therefore creates
significantly lower elastic response.
“The wireless motility capsule monitoring system allowed us to
demonstrate that the superabsorbent hydrogel, in contrast to
modified cellulose alone or placebo, accelerated colonic transit
time,” said Dr. Kyle Staller, Center for Neurointestinal Health and
Division of Gastroenterology at Harvard-affiliated Massachusetts
General Hospital. “This finding suggests that the three-dimensional
structure of Gelesis’ hydrogel technology and specific elastic
response may have contributed to the observed improvements in
colonic transit time over the active fiber control in this
study.”
The primary end-point of this randomized, double-blind study was
the change in CTT from pre-treatment to post-treatment as measured
by wireless motility capsules. The test involves swallowing a small
data recording device which transmits information to a wireless
data receiver.
Two populations were evaluated separately, 27 subjects with CIC
and 13 subjects with irritable bowel syndrome with constipation
(IBS-C). Patients were randomized into three treatment groups to
receive 21 days of treatment with either GS500 (n=20), active
control (modified cellulose, n=11) or placebo (n=9). Each subject’s
CTT was measured during the third week of treatment and compared to
their baseline, collected during 7 days of pre-treatment. Secondary
outcome measures included improvement of relevant gastro intestinal
(GI) symptoms.
In the CIC population on treatment, colonic transit time was
reduced by approximately 16 hours (~31%) compared to baseline
(P=0.02 compared to placebo). No statistically significant change
was observed in the placebo or the active control groups. No
improvement was observed in the IBS-C population, as well as no
change in the reported GI symptoms which were the secondary
endpoints. Two randomized patients did not complete the study, one
in the treatment group due to a GI related AE, and one in the
placebo group due to a faulty monitoring device. No serious adverse
events were reported.
This pilot study of 40 subjects was powered to detect
improvement in CTT (the primary end-point). Recent data suggest
that colonic transit time influences gut health and a longer fecal
retention time is associated with CIC symptoms and less microbiome
diversity. Further studies are required to assess the effect of
Gelesis’ hydrogel technology on symptom improvement.
About Chronic Idiopathic ConstipationChronic idiopathic
constipation (CIC) is a common gastrointestinal disorder. Its
primary symptom is a low frequency of bowel movements, which can
cause significant discomfort and negative impact on
quality-of-life. CIC is estimated to affect between 15 and 25
percent of the general population in North America.
About GelesisGelesis 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™.
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 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 (GS300,
GS400, GS500) 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). Recent
preclinical data presented this year support the potential role of
this novel hydrogel platform technology in restoring gut barrier
function and intestinal tissue health.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190519005027/en/
InvestorsAllison Mead Talbot+1 617 651
3156amt@puretechhealth.com
U.S. mediaTom Donovan+1 857 559
3397tom@tenbridgecommunications.com
Puretech Health (LSE:PRTC)
Gráfica de Acción Histórica
De Mar 2024 a Abr 2024
Puretech Health (LSE:PRTC)
Gráfica de Acción Histórica
De Abr 2023 a Abr 2024