TIDMPRTC
PureTech Health PLC
02 November 2022
2 November 2022
PureTech Health plc
PureTech Founded Entity Gelesis Announces Two Presentations at ObesityWeek 2022
Dr. Frank Greenway presents data from the LIGHT-UP study with
Gelesis' oral hydrogel treatment GS200
Waist to Height Ratio, known to be correlated with insulin
resistance & metabolic syndrome, was a predictor of weight loss
response in the LIGHT-UP study based on a post-hoc analysis
As previously reported, the LIGHT-UP study met its primary
endpoint with 6 out of 10 responding to the treatment, achieving an
average of 11% weight loss and 5.6 inches reduction of their waist
within only 25 weeks
Gelesis also presents data d emonstrating that Gelesis'
investigational clinical-stage oral superabsorbent hydrogel Gel-B
preferentially enhances the growth of Akkermansia muciniphila in
preclinical models compared to prebiotics
Akkermansia muciniphila has/have been associated with thickened
mucosal lining of the gut, improved gut barrier function, and lean
body mass
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company, noted today
that its Founded Entity, Gelesis Holdings Inc. (NYSE: GLS)
("Gelesis") the maker of Plenity for weight management, announced
two presentations at ObesityWeek 2022 in San Diego.
Frank L. Greenway, MD, Medical Director and Professor at the
Pennington Biomedical Research Center, Louisiana State University
and the principal investigator of the LIGHT-UP study, will give an
oral presentation on Wednesday, November 2 at 4:00pm PDT. The data
support Waist to Height Ratio as a potential biomarker to help
predict weight loss response with GS200 treatment in people with
prediabetes or type 2 diabetes.
Considering the previously reported findings from the LIGHT-UP
study, the significant improvement in fasting insulin and
postprandial insulin response, as well as the notable reduction in
waist circumference (secondary endpoints), a post hoc analysis was
conducted to explore whether abdominal fat affects the level of
weight loss response with the novel hydrogel treatment. Waist to
Height Ratio was used for this analysis as it represents a simple
metric for body shape and potential abdominal fat, known to be
associated with insulin resistance & metabolic syndrome.
Gelesis also released new data from a study that investigated
how an oral superabsorbent hydrogel (Gel-B or GS200) increases
Akkermansia muciniphila in comparison to two prebiotics, inulin,
and psyllium. A. muciniphila is a bacteria associated with
thickened mucosal lining of the gut, that encourages improved gut
barrier function, and lean body mass.
Gelesis, along with collaborators at Humanitas University in
Milan, Italy, also examined how Gel-B supports growth of A.
muciniphila in an animal model. The group found that A. muciniphila
grows in the presence of Gel-B as early as two weeks
post-treatment. The study provides further support of the
hypothesis that the physical structure of the oral superabsorbent
hydrogels and its specific mechanical properties (e.g, level of
elasticity) provides the environment to supports the growth of A.
muciniphila.
The full text of the announcement from Gelesis is below:
Dr. Frank Greenway to Present Data from the LIGHT-UP Study with
Gelesis' Oral Hydrogel Treatment GS200 at Obesity Week
Waist to Height Ratio, known to be correlated with insulin
resistance & metabolic syndrome, was a predictor of weight loss
response in the study based on a post-hoc analysis
As previously reported, the LIGHT-UP study met its primary
endpoint with 6 out of 10 responding to the treatment, achieving an
average of 11% weight loss and 5.6 inches reduction of their waist
within only 25 weeks
BOSTON, NOVEMBER 1, 2022 - Gelesis Holdings Inc. (NYSE: GLS)
("Gelesis" or the "Company") the maker of Plenity for weight
management, today announced Dr. Frank Greenway will give an oral
presentation at Obesity Week in San Diego, on Wednesday, November 2
at 4:00pm PDT.
Frank L. Greenway, MD, Medical Director and Professor at the
Pennington Biomedical Research Center, Louisiana State University
and the principal investigator of the LIGHT-UP study, will present
data supporting Waist to Height Ratio as a potential biomarker to
help predict weight loss response with GS200 treatment in people
with prediabetes or type 2 diabetes.
Considering the previously reported findings from the LIGHT-UP
study, the significant improvement in fasting insulin and
postprandial insulin response, as well as the notable reduction in
waist circumference (secondary endpoints), a post hoc analysis was
conducted to explore whether abdominal fat affects the level of
weight loss response with the novel hydrogel treatment. Waist to
Height Ratio was used for this analysis as it represents a simple
metric for body shape and potential abdominal fat, known to be
associated with insulin resistance & metabolic syndrome.
GS200 is an orally administered superabsorbent hydrogel taken by
capsule with water 10 minutes before lunch and dinner and is
designed to act mechanically in the gastrointestinal tract in order
to induce weight loss in patients with prediabetes and type 2
diabetes.
"Paradoxically, the subgroup with a higher ratio, a marker of
insulin resistance, achieved a better response to GS200 reporting
8.1% weight loss at 6 months," said Dr. Greenway. "The ratio can be
a simple tool to help clinicians select patients where GS200 work
best for them. The causes and mechanisms to explain this
preferential response continue to be investigated. Growing evidence
is emerging on the interaction between gut wall permeability, gut
microbiota shifts and metabolic health, we need more studies to
understand whether gut mechanisms could explain these intriguing
findings with GS200."
About Gelesis
Gelesis Holdings Inc. (NYSE: GLS) ("Gelesis") is a
consumer-centered biotherapeutics company and the maker of
Plenity(R), which is inspired by nature and FDA cleared to aid in
weight management. Our first-of-their-kind non-systemic
superabsorbent hydrogels are made entirely from naturally derived
building blocks. They are inspired by the composition and
mechanical properties of raw vegetables, taken by capsule, and act
locally in the digestive system, so people feel satisfied with
smaller portions. Our portfolio includes Plenity(R) and potential
therapies in development for patients with Type 2 Diabetes,
Non-alcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic
Steatohepatitis (NASH), and Functional Constipation. For more
information, visit gelesis.com , or connect with us on Twitter
@GelesisInc.
Plenity(R) is indicated to aid weight management in adults with
excess weight or obesity, a Body Mass Index (BMI) of 25-40 kg/m(2),
when used in conjunction with diet and exercise.
Important Safety Information about Plenity
-- Patients who are pregnant or are allergic to cellulose,
citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide
should not take Plenity.
-- To avoid impact on the absorption of medications:
o For all medications that should be taken with food, take them
after starting a meal.
o For all medications that should be taken without food (on an
empty stomach), continue taking on an empty stomach or as
recommended by your physician.
-- The overall incidence of side effects with Plenity was no
different than placebo. The most common side effects were diarrhea,
distended abdomen, infrequent bowel movements, and flatulence.
-- Contact a doctor right away if problems occur. If you have a
severe allergic reaction, severe stomach pain, or severe diarrhea,
stop using Plenity until you can speak to your doctor.
Rx Only. For the safe and proper use of Plenity or more
information, talk to a healthcare professional, read the Patient
Instructions for Use , or call 1-844-PLENITY.
About Gelesis' LIGHT-UP Clinical Study
The multicenter, double-blind, randomized, placebo-controlled
study enrolled 254 subjects and was designed to assess the change
in body weight in adults with overweight or obesity, who have
prediabetes or diabetes, after 25 weeks of treatment with a new
oral superabsorbent hydrogel (GS200) or placebo. The study met both
of its primary endpoints: the proportion of participants who
achieved at least 5% body weight loss and the change in body weight
after six months of therapy.
A highly binary effect was observed with the GS200 treatment
group, with a clear separation between responders and
non-responders as early as after 6 weeks of treatment. Among the
adults who completed the study protocol requirements (PP
population), 64% of GS200-treated adults were Responders vs. 41% in
the placebo group (p=0.001). In the analysis which also included
data from the participants who didn't fully complete the study
(ITT-MI), 55% of GS200-treated adults were Responders vs. 34% in
the placebo group (p=0.0004). The average body weight loss of the
Responders was 11% (approximately 23 pounds) and their waist
circumference was reduced by 5.5 inches on average. Importantly,
Gelesis treated individuals had 2.8 higher odds compared with
placebo to become Responders (adjusted odds ratio = 2.83,
P=0.0004), achieving the first primary endpoint of the study.
With respect to average total weight loss, the complete GS200
treatment group (including both Responders and Non-Responders)
demonstrated superiority over placebo after 25 weeks of treatment
(body weight loss of 7.1% vs. 4.6%, P=0.0029 in the PP population
or 6.9% vs. 4.3%, P=0.0011 in the ITT population), thereby
achieving the second primary endpoint.
GS200 demonstrated a highly favorable safety and tolerability
profile as the overall incidence of adverse events (AEs) in adults
treated with GSP200 was similar to the incidence of AEs in the
placebo group.
Forward-Looking Statements
Certain statements, estimates, targets and projections in this
press release may constitute "forward-looking statements" within
the meaning of the federal securities laws. The words "anticipate,"
"believe," continue," "could," "estimate," "expect," "intend,"
"may," "might," "plan," "possible," "potential," "predict,"
"project," "should," "strive," "would" and similar expressions may
identify forward-looking statements, but the absence of these words
does not mean that statement is not forward looking.
Forward-looking statements are predictions, projections and other
statements about future events that are based on current
expectations and assumptions and, as a result, are subject to risks
and uncertainties. Forward-looking statements include, but are not
limited to, statements regarding Gelesis' or its management team's
expectations, hopes, beliefs, intentions or strategies regarding
the future, including those relating to Gelesis' expected operating
and financial performance and market opportunities. In addition,
any statements that refer to projections, forecasts, or other
characterizations of future events or circumstances, including any
underlying assumptions, are forward-looking statements.
Forward-looking statements speak only as of the date they are made.
Readers are cautioned not to put undue reliance on forward-looking
statements, and Gelesis assumes no obligation and does not intend
to update or revise these forward-looking statements, whether as a
result of new information, future events, or otherwise. Gelesis
gives no assurance that any expectations set forth in this press
release will be achieved. Various risks and uncertainties (some of
which are beyond Gelesis' control) or other factors could cause
actual future results, performance or events to differ materially
from those described herein. Some of the factors that may impact
future results and performance may include, without limitation: (i)
the ability of Gelesis to raise financing, if and when needed; (ii)
the ability of Gelesis to continue as a going concern; (iii)
Gelesis' ability to achieve and maintain widespread market
acceptance of Plenity; (iv) the impact of current and future
applicable laws and regulations and Gelesis' ability to comply with
such laws and regulations; (v) Gelesis' ability to produce adequate
supply of Plenity, including Gelesis' ability to continue to invest
in manufacturing capacity and to build additional manufacturing
sites; (vi) the development of the telehealth market and
regulations related to remote healthcare; (vii) global economic,
political and social conditions and uncertainties in the markets
that Gelesis serves, including risks and uncertainties caused by
the COVID-19 pandemic or other natural or man-made disasters;
(viii) Gelesis' ability to enter into strategic collaborations, to
acquire businesses or products or form strategic alliances and to
realize the benefits of such collaborations, acquisitions and
alliances; (ix) the level of demand, and willingness of potential
members to pay out-of-pocket for, Plenity; (x) the ability of
Gelesis to enforce its intellectual property rights and proprietary
technology ; (xi) the risk that a third-party's activities,
including with respect to third parties that Gelesis has granted
outlicenses to or granted limited exclusive or non-exclusive
commercial rights, may overlap or interfere with the
commercialization of Plenity; (xii) Gelesis' ability to
successfully develop and expand its operations and manufacturing
and to effectively manage such growth; (xiii) Gelesis' business
partners' ability to successfully launch and commercialize Plenity
in certain key markets; (xiv) risk relating to the loss of Gelesis'
suppliers or distributors, or their inability to provide adequate
supply of materials or distribution; (xv) the risk that Gelesis'
business partners may experience significant disruptions in their
operations; (xvi) Gelesis' ability to retain its senior executive
officers and to attract and keep senior management and key
scientific and commercial personnel; (xvii) Gelesis' ability to
identify and discover additional product candidates and to obtain
and maintain regulatory approval for such candidates; (xviii) risks
related to potential product liability exposure for Plenity or
other future product candidates; (xix) risks related to adverse
publicity in the weight management industry, changes in the
perception of Gelesis' brands, and the impact of negative
information or inaccurate information about Gelesis on social
media; (xx) Gelesis' ability to enhance its brand recognition,
increase distribution of Plenity and generate product sales and
reduce operating losses going forward; (xxi) the impact of risks
associated with economic, financial, political, environmental and
social matters and conditions on Gelesis' supply chain, its
manufacturing operations and other aspects of its business; (xxii)
Gelesis' ability to accurately forecast revenue and appropriately
monitor its associated expenses in the future; (xxiii) Gelesis'
ability to compete against other weight management and wellness
industry participants or other more effective or more favorably
perceived weight management methods, including pharmaceuticals,
devices and surgical procedures; (xxiv) foreign currency
fluctuations and inflation; (xxv) the risk that Gelesis fails to
maintain adequate operational and financial resources or to raise
additional capital or generate sufficient cash flows; (xxvi)
Gelesis' ability to successfully protect against security breaches
and other disruptions to its information technology structure;
(xxvii) the ability of Gelesis to maintain its listing on the New
York Stock Exchange; (xxviii) failure to realize the anticipated
benefits of the business combination; and (xxix) other important
factors discussed in the "Risk Factors" section of Gelesis' most
recent Annual Report on Form 10-K and in other filings that Gelesis
makes with the Securities and Exchange Commission. These filings
address other important risks and uncertainties that could cause
actual results and events to differ materially from those contained
in the forward-looking statements.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercializing highly
differentiated medicines for devastating diseases, including
inflammatory, fibrotic and immunological conditions, intractable
cancers, lymphatic and gastrointestinal diseases and neurological
and neuropsychological disorders, among others. The Company has
created a broad and deep pipeline through the expertise of its
experienced research and development team and its extensive network
of scientists, clinicians and industry leaders.
This pipeline, which is being advanced both internally and
through PureTech's Founded Entities, is comprised of 27
therapeutics and therapeutic candidates, including two that have
received both U.S. FDA clearance and European marketing
authorization, as of the date of PureTech's most recently filed
Annual Report and corresponding Form 6-K. All of the underlying
programs and platforms that resulted in this pipeline of
therapeutic candidates were initially identified or discovered and
then advanced by the PureTech team through key validation points
based on unique insights in immunology and drug development.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including without limitation those
related to the potential therapeutic benefits of GS200 or Gel-B,
and Gelesis' future prospects, development plans, and strategies .
The forward-looking statements are based on current expectations
and are subject to known and unknown risks, uncertainties and other
important factors that could cause actual results, performance and
achievements to differ materially from current expectations,
including, but not limited to, those risks, uncertainties and other
important factors described under the caption "Risk Factors" in our
Annual Report on Form 20-F for the year ended December 31, 2021
filed with the SEC and in our other regulatory filings. 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, we
disclaim any obligation to update or revise these forward-looking
statements, whether as a result of new information, future events
or otherwise.
Contact:
PureTech
Public Relations
publicrelations@puretechhealth.com
Investor Relations
IR@puretechhealth.com
EU Media
Ben Atwell, Rob Winder
+44 (0) 20 3727 1000
ben.atwell@FTIconsulting.com
U.S. Media
Nichole Sarkis
+1 774 278 8273
nichole@tenbridgecommunications.com
This information is provided by Reach, the non-regulatory press
release distribution service of RNS, part of the London Stock
Exchange. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
Reach is a non-regulatory news service. By using this service an
issuer is confirming that the information contained within this
announcement is of a non-regulatory nature. Reach announcements are
identified with an orange label and the word "Reach" in the source
column of the News Explorer pages of London Stock Exchange's
website so that they are distinguished from the RNS UK regulatory
service. Other vendors subscribing for Reach press releases may use
a different method to distinguish Reach announcements from UK
regulatory news.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
NRAFIFEILLLFIIF
(END) Dow Jones Newswires
November 02, 2022 07:35 ET (11:35 GMT)
Puretech Health (LSE:PRTC)
Historical Stock Chart
From Jun 2024 to Jul 2024
Puretech Health (LSE:PRTC)
Historical Stock Chart
From Jul 2023 to Jul 2024