TIDMPRTC
PureTech Health PLC
25 March 2019
25 March 2019
PureTech Health plc
PureTech's Affiliate Gelesis Presents Data Supporting Lead
Product Candidate's Positive Effect on People with Prediabetes,
Untreated Diabetes, and Elevated Insulin Resistance
Individuals with prediabetes and those with untreated type 2
diabetes had six times higher odds to achieve >=10% weight loss
compared to placebo
Individuals with high insulin resistance achieved significant
drop in HOMA-IR levels on treatment independent of their level of
weight loss
PureTech Health plc (LSE: PRTC) ("PureTech Health"), an advanced
biopharmaceutical company developing novel medicines for
dysfunctions of the Brain-Immune-Gut (BIG) Axis, is pleased to note
that its affiliate Gelesis today presented clinical data atO 2019,
the Endocrine Society's annual meeting, suggesting that elevated
fasting plasma glucose could be a useful and unique predictor to
identify individuals who have higher adjusted odds to achieve
significant weight loss with the Company's lead product candidate,
Gelesis100.
Furthermore, individuals with high insulin resistance, as
measured by HOMA-IR, at the start of the trial had a statistically
significant reduction in HOMA-IR over the six-month treatment
period - an effect observed both among those who lost significant
weight while taking Gelesis100 and those who did not. Elevated
insulin resistance is a significant driver of diabetes.
Gelesis100 is a superabsorbent hydrogel in development for the
potential treatment of overweight and obesity. Data shared atO 2019
show that individuals with prediabetes and untreated type 2
diabetes were particularly responsive to Gelesis100 in the pivotal
GLOW study. They had six times higher odds of achieving >=10%
weight loss over six months, compared to placebo. Across the entire
treatment group in the GLOW study, baseline fasting plasma glucose
was correlated with greater weight loss (R =-0.24, P = 0.0144). The
pronounced weight loss effect of Gelesis100 treatment in this
population, which is at higher clinical risk, was also observed in
a previous pilot study.
Eric Elenko, PhD, chief innovation officer at PureTech Health,
said: "These findings suggest that Gelesis100 could be an important
new tool for aiding in weight management in patients at high risk
of diabetes or who have diabetes and are not yet on medication.
Additional study is needed, but these data suggest that baseline
measures of fasting plasma glucose could help predict which
individuals are most likely to respond to Gelesis100 with
significant weight loss of greater than 10% of their body weight.
Gelesis100 could also be a compelling option for people with high
insulin resistance. These data are particularly exciting given that
obesity and diabetes are tremendous public health concerns and
areas of high unmet medical need."
The full text announcement from Gelesis is as follows:
Gelesis Presents Expanded Data Showing Impact of Gelesis100
Hydrogel on Patients with Prediabetes, Untreated Diabetes, and
Elevated Insulin Resistance
Individuals with prediabetes and those with untreated type 2
diabetes had six times higher odds to achieve >=10% weight loss
compared to placebo
Individuals with high insulin resistance achieved significant
drop in HOMA-IR levels on treatment independent of their level of
weight loss
BOSTON, March 25, 2019 - Gelesis, a biotechnology company
developing first-in-class mechanotherapeutics to treat obesity and
other chronic diseases related to the gastrointestinal (GI)
pathway, today announced clinical data from its pivotal GLOW study
suggesting that elevated fasting plasma glucose could be a useful
and unique predictor to identify individuals who have higher
adjusted odds to achieve significant weight loss with Gelesis100.
As observed in a previous pilot study, participants with
prediabetes or untreated type 2 diabetes were particularly
responsive to its lead product candidate for weight management,
Gelesis100. In addition, participants with high insulin resistance
improved their insulin sensitivity significantly on treatment,
including the non-responders (defined as those achieving less than
5% total body weight loss). The data were presented in two posters
atO 2019, the Endocrine Society's annual meeting.
"These findings provide compelling data that Gelesis100 may have
particularly pronounced benefits for patients with elevated fasting
blood glucose and diabetes. While additional studies with a longer
time period need to be done, the metabolic and weight loss effects
observed in the GLOW study support the concept that Gelesis100
could be an option for patients with high insulin resistance," said
Harry L. Leider, M.D., MBA., FACPE, Chief Medical Officer of
Gelesis. "We have already demonstrated that Gelesis100 is an
effective tool for weight management. We now have data suggesting
that the hydrogel may modulate the endocrine and metabolic systems
to positive effect. We are eager to continue exploring the
mechanisms behind these findings."
The data presented atO 2019 come from subgroup analysis of the
Gelesis Loss of Weight (GLOW) study, a pivotal multicentre,
double-blind, placebo-controlled study of Gelesis100. The
overarching study showed statistically significant separation from
placebo in the ITT population and found that nearly 6 in 10 people
treated with Gelesis100 were responders who lost, on average, 10%
(about 22 pounds) of their body weight over six months.
In this subgroup analysis, researchers found that 44% of
patients with elevated fasting blood glucose or untreated type 2
diabetes were "super-responders," meaning they lost at least 10% of
their body weight (30 pounds on average) when treated with
Gelesis100 (adjusted OR = 6.1, P = 0.007). Interestingly they had
six times the odds of being super-responders, compared to placebo.
Across the entire treatment group in the GLOW study, baseline
fasting plasma glucose was correlated with greater weight loss (R
=-0.24, P = 0.0144). The pronounced weight loss effect of
Gelesis100 treatment in this population, which is at higher
clinical risk, was also observed in the previous FLOW pilot study.
The repeated findings suggest that Gelesis100 may be a new tool for
aiding in weight management in patients at high risk of diabetes or
diabetes-related complications.
"Participants with elevated fasting blood glucose and untreated
type 2 diabetes had higher odds of achieving loss of at least 10%
of their body weight. This was an important result as this
population almost invariably has lesser weight loss in behavioural
and medication trials," said Scott Kahan, M.D., MPH, director of
the National Center for Weight and Wellness and a physician
specializing in obesity.
A separate analysis found that patients with high insulin
resistance - a significant driver of diabetes - had positive
metabolic responses to treatment with Gelesis100. Insulin
resistance was measured by homeostatic model assessment - insulin
resistance (HOMA-IR). Patients with high IR at the start of the
clinical trial (mean baseline HOMA= 5.0) had a statistically
significant reduction in HOMA-IR over the six-month treatment
period (-22.3 +/- 9.5%, P= 0.021). Importantly this reduction was
observed both in patients that were weight loss responders (with 5%
or greater weight loss) and also in non-weight loss responders. The
HOMA-IR decrease in the subgroup overall was driven by a
significant reduction in fasting serum insulin.
The GLOW study was designed to assess change in body weight in
adults with overweight or obesity after six months of treatment
with Gelesis100. Topline results of the study were announced in
September 2017. The study had two predefined co-primary endpoints:
at least 35% of patients taking Gelesis100 achieving >= 5%
weight loss (categorical endpoint) and placebo adjusted weight loss
to be assessed in two ways (super-superiority margin of 3% and also
simple superiority). The study met and exceeded the pre-defined
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 Gelesis100 treatment over the
placebo group (-6.4% vs. -4.4%, P=0.0007). Gelesis100-treated
individuals had twice the odds of achieving at least 5% and at
least 10% weight loss vs. placebo (adjusted odds ratio [OR]: 2.0,
P=0.0008; adjusted OR: 2.1, P=0.0107, respectively).
The overall incidence of adverse events in the Gelesis100
treatment group was no different than placebo (71% in both groups).
The most common AEs were gastrointestinal disorders (186 AEs in 96
[43%] subjects in the Gelesis100 arm, compared to 134 events in 72
[34%] subjects receiving placebo), infections and infestations (94
events in 74 [33%] subjects with Gelesis100 and 101 events in 70
[33%] subjects with placebo), and musculoskeletal and connective
tissue disorders (38 events in 31 [14%] subjects with Gelesis100
and 45 in 34 [16%] subjects with placebo). There were no serious
adverse events (SAE) in the Gelesis100 treatment group, whereas
there was one (1) SAE in the placebo treatment group.
Gelesis100 has been extensively evaluated in clinical studies
and has been submitted to the U.S. Food and Drug Administration for
review.
About Gelesis 100
Gelesis100 is a non-systemic, superabsorbent hydrogel in
development for the potential treatment of overweight or obesity.
It is made by cross linking two naturally-derived building blocks,
modified cellulose and citric acid, that create a three-dimensional
matrix. Gelesis100 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 Gelesis100 hydrogel mass
increases the volume and elasticity of the stomach and small
intestine contents, promoting fullness and potentially increasing
satiety to help patients lose weight. 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
faeces. Gelesis100 is considered a medical device because it
achieves its primary intended purpose through a mechanical mode of
action. This investigational product and its earlier prototypes
have been studied in more than 450 patients (excluding patients
treated by placebo) across five clinical studies throughout the
United States, Canada, and Europe and in these demonstrating a
strong efficacy, tolerability and safety profile. Other than an
increase in overall gastrointestinal adverse events (AEs), most of
which were assessed as mild, there was no difference in the
incidence and severity of AEs between the Gelesis100 and placebo
groups. In both treatment groups, most AEs were mild or moderate in
intensity. No serious adverse events were observed in the
Gelesis100 group. For more information, visit gelesis.com.
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. The company's lead product candidate, Gelesis100,
has been submitted to the FDA for review as a weight management
aid. Additionally, Gelesis is developing its second candidate,
Gelesis200, a hydrogel optimised for weight loss and glycaemic
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 commercialisation. 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.
About PureTech Health
PureTech Health (LSE: PRTC) is an advanced biopharmaceutical
company developing BIG medicines for dysfunctions of the
Brain-Immune-Gut axis. The Company has gained deep insights into
the connection between these systems and the resulting role in
diseases that have proven resistant to established therapeutic
approaches. By harnessing this emerging field of human biology,
PureTech Health is developing new categories of medicines with the
potential to have great impact on people with serious diseases.
PureTech Health is advancing a rich pipeline of innovative
therapies with an unbiased, non-binary, and capital efficient
R&D model across its affiliates and its internal labs.
PureTech's affiliates include seven clinical-stage platforms with
two product candidates that have been filed with the US Food and
Drug Administration (FDA) for review and other novel pre-clinical
programmes. The PureTech Health pipeline includes ground-breaking
platforms and therapeutic candidates that were developed in
collaboration with some of the world's leading experts.
PureTech's internal research and development is centred on
tissue-selective immunomodulation for the treatment of oncology,
autoimmune, and CNS-related disorders, with a near-term focus on
targeting newly-discovered, foundational immunosuppressive
mechanisms in oncology and novel approaches that harness the
lymphatic infrastructure.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
Forward Looking Statement
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, those risks and uncertainties described in the risk factors
included in the regulatory filings for PureTech Health plc. These
forward-looking statements are based on assumptions regarding the
present and future business strategies of the company and the
environment in which it will operate in the future. Each
forward-looking statement speaks only as at the date of this press
release. Except as required by law and regulatory requirements,
neither the company nor any other party intends to update or revise
these forward-looking statements, whether as a result of new
information, future events or otherwise.
Contact:
Investors EU media U.S. media
Allison Mead Talbot Ben Atwell, Rob Winder Tom Donovan
+1 617 651 3156 +44 (0) 20 3727 1000 +1 857 559 3397
amt@puretechhealth.com ben.atwell@FTIconsulting.com tom@tenbridgecommunications.com
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END
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March 25, 2019 14:00 ET (18:00 GMT)
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