TIDMPRTC
PureTech Health PLC
25 August 2022
25 August 2022
PureTech Health plc
PureTech Founded Entity Gelesis Presented Clinical Data from the
LIGHT-UP Study at the International Congress of Endocrinology that
Suggests New Gelesis Oral Hydrogel May Improve Insulin Sensitivity
and Favorably Impact Metabolic Syndrome
The 25-week weight loss study which achieved its previously
reported primary endpoints also examined the effects of GS200 on
insulin resistance
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a biotherapeutics company, today announces that its
Founded Entity, Gelesis Holdings Inc. (NYSE: GLS) ("Gelesis") the
maker of Plenity for weight management, released a poster
presentation at the International Congress of Endocrinology in
Singapore. The LIGHT-UP study evaluated the safety and efficacy of
GS200, an investigational oral hydrogel, which was designed to
emulate the properties of ingested raw vegetables, with slightly
different mechanical properties compared to Plenity (GS100).
The LIGHT-UP study was conducted over 25 weeks in 254
participants with prediabetes or type 2 diabetes and a BMI of 27-40
kg/m2. It met its primary endpoints and GS200 reported a highly
favorable categorial weight loss response and tolerability in a
population that often struggles to lose weight and is at high risk
for obesity-related complications. One out of three GS200-treated
adults were "super responders," losing at least 10% of their body
weight and on average losing 13% (30 pounds), or 7 inches off their
waist circumference in only 25 weeks.
The full text of the announcement from Gelesis is as
follows:
Clinical Data from the LIGHT-UP Study Presented at the
International Congress of Endocrinology Suggests New Gelesis Oral
Hydrogel May Improve Insulin Sensitivity and Favorably Impact
Metabolic Syndrome
The 25-week weight loss study which achieved its previously
reported primary endpoints also examined the effects of GS200 on
insulin resistance
BOSTON, AUGUST 25, 2022 - Gelesis Holdings Inc. (NYSE: GLS)
("Gelesis" or the "Company") the maker of Plenity for weight
management, today released a poster presentation at the
International Congress of Endocrinology in Singapore. The LIGHT-UP
study evaluated the safety and efficacy of GS200, an
investigational oral hydrogel, which was designed to emulate the
properties of ingested raw vegetables, with slightly different
mechanical properties compared to Plenity (GS100).
The LIGHT-UP study was conducted over 25 weeks in 254
participants with prediabetes or type 2 diabetes and a BMI of 27-40
kg/m2. It met its primary endpoints and GS200 reported a highly
favorable categorial weight loss response and tolerability in a
population that often struggles to lose weight and is at high risk
for obesity-related complications. One out of three GS200-treated
adults were "super responders," losing at least 10% of their body
weight and on average losing 13% (30 pounds), or 7 inches off their
waist circumference in only 25 weeks.
"In previous studies we observed better weight loss response for
individuals with pre-diabetes. In this study we wanted to
understand if we could replicate this intriguing finding also with
people who have type 2 diabetes, since typically weight loss is
even more challenging for them" said Frank L. Greenway, MD, Medical
Director and Professor at the Pennington Biomedical Research
Center, Louisiana State University and one of the study's lead
investigators. "These findings could help us to understand the
reason why the hydrogel therapy works better for people with
elevated insulin resistance, which is important given the
heterogeneity of the mechanisms driving weight gain and
obesity."
The study also investigated meal-time insulin release in people
with prediabetes using a two-hour oral glucose tolerance test.
Participants with pre-diabetes treated with GS200 had significantly
less total mealtime insulin release, compared to placebo, the mean
difference was -22.0%, P=0.04. The peak level of mealtime insulin
was also significantly lower for people that used GS200 when
compared to placebo with a mean difference of 47.3<MU>U/mL,
P=0.03.
"These reductions in mealtime insulin release were statistically
significant even after controlling for changes in weight loss
between GS200 and placebo, indicating that the observed
improvements are independent of weight loss, suggesting additional
mechanisms involved in the metabolic effects of the oral hydrogel
technology," said Elaine Chiquette, Gelesis Chief Scientific
Officer. "These are exciting results, and we continue to
investigate how GS200 affects insulin response and weight loss in
people with prediabetes and type 2 diabetes."
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 biotherapeutics company dedicated to changing the
treatment paradigm for devastating diseases. 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 and a third that is
expected to be filed soon for FDA approval, as of the date of
PureTech's most recently filed Half-Year 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 statements that are or may be
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, 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 EU media U.S. media
Public Relations Ben Atwell, Rob Winder Nichole Sarkis
publicrelations@puretechhealth.com +44 (0) 20 3727 1000 +1 774 278 8273
Investor Relations ben.atwell@FTIconsulting.com nichole@tenbridgecommunications.com
IR@puretechhealth.com
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