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BOSTON–(BUSINESS WIRE)–PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Firm”), a clinical-stage biotherapeutics firm introduced that its Based Entity, Gelesis Holdings, Inc. (NYSE: GLS) (“Gelesis”), a consumer-focused biotherapeutics firm and the maker of Plenity®, right now introduced outcomes from the LIGHT-UP medical trial for adults with chubby or weight problems who’ve prediabetes or sort 2 diabetes and have been handled with both GS200 or placebo. Roughly 6 out of 10 adults handled with GS200 achieved clinically significant response to therapy (attaining no less than 5% physique weight reduction), shedding on common 11% of their physique weight (~23 kilos) and a mean discount of 5.5 inches off their waist circumference. Roughly 1 out of three GS200-treated adults have been “tremendous responders,” shedding no less than 10% of their physique weight and on common shedding 13% (~30 kilos), or 7 inches off their waist circumference. The general incidence of opposed occasions (AEs) in adults handled with GS200 was just like the incidence of AEs within the placebo group. The detailed findings have been introduced at three poster shows on the European Congress on Weight problems 2022.
GS200 is an orally administered superabsorbent hydrogel taken by capsule with water 10 minutes earlier than lunch and dinner and is designed to behave mechanically within the gastrointestinal tract with a view to induce satiety in sufferers with prediabetes and sort 2 diabetes. Individuals in LIGHT-UP have been additionally instructed to comply with a modestly diminished calorie weight-reduction plan together with moderate-intensity bodily exercise. Within the GS200 group there was clear and early separation between responders and non-responders to therapy, and response to remedy may very well be predicted as early as 6 weeks of therapy.
The total textual content of the announcement from Gelesis is as follows:
Scientific Knowledge Offered on the European Congress on Weight problems 2022 Demonstrates Weight Loss with GS200 in Adults with Prediabetes and Kind 2 Diabetes
Gelesis’ six-month research of weight reduction in adults with chubby or weight problems who’ve prediabetes or sort 2 diabetes met each of its main endpoints: the proportion of individuals who achieved no less than 5% physique weight reduction (i.e., “Categorical”) and the change in physique weight after six months of remedy
GS200 demonstrated a extremely favorable Categorial weight reduction response and tolerability in a inhabitants that usually struggles to shed extra pounds and is at excessive threat for obesity-related issues; the general incidence of opposed occasions (AEs) in adults handled with GS200 was just like the placebo group
~6 out of 10 GS200-treated adults achieved no less than 5% weight reduction (“Responders”), shedding on common 11% (~23 kilos), or 5.5 inches off their waist circumference in solely 24 weeks
~1 out of three GS200-treated adults have been “tremendous responders,” shedding no less than 10% of their physique weight and on common shedding 13% (~30 kilos), or 7 inches off their waist circumference in solely 24 weeks
BOSTON, MAY 4, 2022 – Gelesis (NYSE: GLS), a consumer-focused biotherapeutics firm and the maker of Plenity®, right now introduced outcomes from the LIGHT-UP medical trial for adults with chubby or weight problems who’ve prediabetes or sort 2 diabetes and have been handled with both GS200 or placebo. Roughly 6 out of 10 adults handled with GS200 achieved clinically significant response to therapy (attaining no less than 5% physique weight reduction), shedding on common 11% of their physique weight (~23 kilos) and a mean discount of 5.5 inches off their waist circumference. Roughly 1 out of three GS200-treated adults have been “tremendous responders,” shedding no less than 10% of their physique weight and on common shedding 13% (~30 kilos), or 7 inches off their waist circumference. The general incidence of opposed occasions (AEs) in adults handled with GS200 was just like the incidence of AEs within the placebo group. The detailed findings have been introduced at three poster shows on the European Congress on Weight problems 2022.
Anti-obesity drugs are prescribed in lower than 2% of individuals with chubby or weight problems within the US primarily as a result of considerations concerning the security or tolerability of current drugs. There’s a want for orally administered therapies that may induce clinically significant weight reduction, with no important elevated security threat, particularly in individuals with sort 2 diabetes or prediabetes since they usually face elevated challenges dropping pounds and have increased threat of growing critical comorbidities.
“There’s a very massive inhabitants of adults with prediabetes and diabetes who’ve a better want for weight reduction as a result of increased medical dangers and a better problem dropping pounds,” mentioned Frank L. Greenway, MD, Medical Director and Professor on the Pennington Biomedical Analysis Heart of the Louisiana State College and one of many research’s lead investigators. “The compelling weight reduction information that favors diabetes and prediabetes is exclusive amongst weight reduction therapies. Its handy oral administration, and really favorable tolerability make it a probably vital instrument to assist clinicians and sufferers obtain clinically significant weight reduction.”
GS200 is an orally administered superabsorbent hydrogel taken by capsule with water 10 minutes earlier than lunch and dinner and is designed to behave mechanically within the gastrointestinal tract with a view to induce satiety in sufferers with prediabetes and sort 2 diabetes. Individuals in LIGHT-UP have been additionally instructed to comply with a modestly diminished calorie weight-reduction plan together with moderate-intensity bodily exercise. Within the GS200 group there was clear and early separation between responders and non-responders to therapy, and response to remedy may very well be predicted as early as 6 weeks of therapy.
“There’s a actual want for tolerable, efficient, and inexpensive therapeutics to assist in weight reduction for sufferers with prediabetes and sort 2 diabetes. Roughly 130 million Individuals have prediabetes or sort 2 diabetes and roughly 80% wrestle with extra weight. Importantly, these people even have a excessive threat of coronary heart illness and different critical power circumstances, associated to chubby and weight problems, making this one of many greatest public well being points going through our society,” mentioned Harry L. Leider, MD, MBA, FACPE, Chief Medical Officer of Gelesis. “These information present that GS200 produces clinically significant weight reduction for almost all of sufferers and that it’s attainable to determine these responders early in therapy. Given the extremely engaging security and tolerability profile, GS200 has the potential to grow to be an thrilling new remedy, particularly amongst these within the decrease spectrum of extra weight who even have prediabetes or sort 2 diabetes.”
About Gelesis’ LIGHT-UP Scientific Examine
The multicenter, double-blind, randomized, placebo-controlled research enrolled 254 topics and was designed to evaluate the change in physique weight in adults with chubby or weight problems, who’ve prediabetes or diabetes, after six months of therapy with a brand new oral superabsorbent hydrogel (GS200) or placebo. The research met each of its main endpoints: the proportion of individuals who achieved no less than 5% physique weight reduction and the change in physique weight after six months of remedy.
A extremely binary impact was noticed with the GS200 therapy group, with a transparent separation between responders and non-responders as early as after 6 weeks of therapy. Among the many adults who accomplished the research protocol necessities (PP inhabitants), 64% of GS200-treated adults have been Responders vs. 41% within the placebo group (p=0.001). Within the evaluation which additionally included information from the individuals who didn’t totally full the research (ITT-MI), 55% of GS200-treated adults have been Responders vs. 34% within the placebo group (p=0.0004). The common physique weight lack of the Responders was 11% (roughly 23 kilos) and their waist circumference was diminished by 5.5 inches on common. Importantly, Gelesis handled people had 2.8 increased odds in contrast with placebo to grow to be Responders (adjusted odds ratio = 2.83, P=0.0004), attaining the primary main endpoint of the research.
With respect to common complete weight reduction, the whole GS200 therapy group (together with each Responders and Non-Responders) demonstrated superiority over placebo after 6 months of therapy (physique weight lack of 7.1% vs. 4.6%, P=0.0029 within the PP inhabitants or 6.9% vs. 4.3%, P=0.0011 within the ITT inhabitants), thereby attaining the second main endpoint.
GS200 demonstrated a extremely favorable security and tolerability profile as the general incidence of opposed occasions (AEs) in adults handled with GSP200 was just like the incidence of AEs within the placebo group.
About GS200
GS200 is a non-systemic, superabsorbent hydrogel in improvement for the therapy of weight problems and for glycemic management. It’s made by using the identical proprietary hydrogel platform know-how Gelesis developed for its beforehand FDA cleared product, GS100 (PlenityTM). Like GS100, GS200 is constituted of naturally derived cross-linked modified cellulose, nonetheless with a better molecular weight. GS200 was designed to hydrate sooner and create a better elastic response within the GI tract in contrast with GS100. Its properties have been optimized in preclinical research based mostly on its impact on the intestine barrier and microbiome, in addition to diminished insulin resistance and weight reduction. Like GS100, GS200 is a three-dimensional matrix of cellulose, able to absorbing a a lot bigger quantity of water within the abdomen and small intestines. Orally administered in capsules with water earlier than meals, GS200 particles quickly take up water within the abdomen and homogenously combine with ingested meals. This creates 1000’s of small particular person gel items with composition (cellulose and water) and elasticity (firmness) just like strong ingested uncooked greens, with none caloric worth. As soon as it arrives within the massive gut, the hydrogel is partially damaged down by naturally occurring enzymes, and loses its three-dimensional construction together with most of its absorption capability. The launched water is reabsorbed within the massive gut, and the remaining cellulosic materials is expelled naturally. GS200 is taken into account a medical system as a result of it achieves its main supposed objective by way of mechanical modes of motion in line with mechanobiology constructs, and it isn’t absorbed by way of the gastrointestinal tract. GS200 obtained a Non-Important Threat (NSR) willpower by the FDA for the LIGHT-UP research.
About Gelesis
Gelesis Holdings Inc. (NYSE: GLS) (“Gelesis”) is a consumer-centered biotherapeutics firm and the maker of Plenity®, which is impressed by nature and FDA cleared to assist in weight administration. Our first-of-their-kind non-systemic superabsorbent hydrogels are made solely from naturally derived constructing blocks. They’re impressed by the composition and mechanical properties of uncooked greens, taken by capsule, and act regionally within the digestive system, so individuals really feel happy with smaller parts. Our portfolio contains commercially accessible Plenity® and potential therapies in improvement for sufferers with Kind 2 Diabetes, Non-alcoholic Fatty Liver Illness (NAFLD)/Non-alcoholic Steatohepatitis (NASH), and Practical Constipation. For extra info, go to gelesis.com, or join with us on Twitter @GelesisInc.
Plenity® is indicated to assist weight administration in adults with extra weight or weight problems, a Physique Mass Index (BMI) of 25–40 kg/m², when used along side weight-reduction plan and train.
Vital Security Details about Plenity
- Sufferers who’re pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide shouldn’t take Plenity.
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To keep away from affect on the absorption of medicines:
- For all drugs that must be taken with meals, take them after beginning a meal.
- For all drugs that must be taken with out meals (on an empty abdomen), proceed taking up an empty abdomen or as advisable by your doctor.
- The general incidence of unwanted side effects with Plenity was no completely different than placebo. The commonest unwanted side effects have been diarrhea, distended stomach, rare bowel actions, and flatulence.
- Contact a health care provider instantly if issues happen. When you have a extreme allergic response, extreme abdomen ache, or extreme diarrhea, cease utilizing Plenity till you may communicate to your physician.
Rx Solely. For the protected and correct use of Plenity or extra info, speak to a healthcare skilled, learn the Patient Instructions for Use, or name 1-844-PLENITY.
Ahead-Trying Statements
Sure statements, estimates, targets and projections on this press launch might represent “forward-looking statements” throughout the which means of the federal securities legal guidelines. The phrases “anticipate,” “consider,” proceed,” “may,” “estimate,” “anticipate,” “intend,” “might,” “would possibly,” “plan,” “attainable,” “potential,” “predict,” “undertaking,” “ought to,” “attempt,” “would” and comparable expressions might determine forward-looking statements, however the absence of those phrases doesn’t imply that assertion is just not ahead trying. Ahead-looking statements are predictions, projections and different statements about future occasions which might be based mostly on present expectations and assumptions and, because of this, are topic to dangers and uncertainties. Ahead-looking statements embrace, however are usually not restricted to, statements relating to our or our administration workforce’s expectations, hopes, beliefs, intentions or methods relating to the longer term, together with these referring to Gelesis’ enterprise mixture with Capstar Particular Objective Acquisition Corp. (“Capstar”) and its anticipated advantages, Gelesis’ efficiency following the enterprise mixture, the aggressive setting through which Gelesis operates, the anticipated future working and monetary efficiency and market alternatives of Gelesis and statements relating to Gelesis’ expectations, hopes, beliefs, intentions or methods relating to the longer term. As well as, any statements that consult with projections, forecasts, or different characterizations of future occasions or circumstances, together with any underlying assumptions, are forward-looking statements. Ahead-looking statements communicate solely as of the date they’re made. Readers are cautioned to not put undue reliance on forward-looking statements, and Gelesis assumes no obligation and doesn’t intend to replace or revise these forward-looking statements, whether or not because of new info, future occasions, or in any other case. Gelesis provides no assurance that any expectations set forth on this press launch shall be achieved. Varied dangers and uncertainties (a few of that are past our management) or different components may trigger precise future outcomes, efficiency or occasions to vary materially from these described herein. Among the components that will affect future outcomes and efficiency might embrace, with out limitation: (i) the scale, demand and development potential of the markets for Plenity® and Gelesis’ different product candidates and Gelesis’ skill to serve these markets; (ii) the diploma of market acceptance and adoption of Gelesis’ merchandise; (iii) Gelesis’ skill to develop progressive merchandise and compete with different firms engaged within the weight reduction trade; (iv) Gelesis’ skill to finance and full efficiently the business launch of Plenity® and its development plans, together with new attainable indications and the medical information from ongoing and future research about liver and different illnesses; (v) failure to comprehend the anticipated advantages of the enterprise mixture, together with because of a delay or problem in integrating the companies of Capstar and Gelesis; (vi) the flexibility of Gelesis to problem fairness or equity-linked securities or receive debt financing sooner or later; (vii) the end result of any authorized proceedings instituted towards Capstar, Gelesis, or others in reference to the enterprise mixture; (viii) the flexibility of Gelesis to keep up its itemizing on the New York Inventory Trade; (ix) the danger that the enterprise mixture disrupts present plans and operations of Gelesis because of Gelesis being a publicly listed issuer; (x) the regulatory pathway for Gelesis’ merchandise and responses from regulators, together with the FDA and comparable regulators exterior of the US; (xi) the flexibility of Gelesis to develop and handle development profitably, preserve relationships with clients and suppliers and retain Gelesis’ administration and key staff; (xii) prices associated to the enterprise mixture, together with prices related to the Gelesis being a publicly listed issuer; (xiii) modifications in relevant legal guidelines or rules; (xiv) the chance that Gelesis could also be adversely affected by different financial, enterprise, regulatory and/or aggressive components; (xv) Gelesis’ estimates of bills and profitability; (xvi) ongoing regulatory necessities, (xvii) any competing merchandise or applied sciences that will emerge, (xviii) the volatility of the telehealth market generally, or inadequate affected person demand; (xix) the flexibility of Gelesis to defend its mental property and fulfill regulatory necessities; (xx) the affect of the COVID 19 pandemic on Gelesis’ enterprise; (xxi) the restricted working historical past of Gelesis; (xxii) the potential affect of inflation on our working bills and prices of products; and (xxiii) different vital components mentioned within the “Threat Elements” part of Gelesis’s most up-to-date Annual Report on Kind 10-Okay filed on April 1, 2022, and in different filings that Gelesis makes with the Securities and Trade Fee. These filings tackle different vital dangers and uncertainties that might trigger precise outcomes and occasions to vary materially from these contained within the forward-looking statements.
About PureTech Well being
PureTech is a clinical-stage biotherapeutics firm devoted to discovering, growing and commercializing extremely differentiated medicines for devastating illnesses, together with inflammatory, fibrotic and immunological circumstances, intractable cancers, lymphatic and gastrointestinal illnesses and neurological and neuropsychological issues, amongst others. The Firm has created a broad and deep pipeline by way of the experience of its skilled analysis and improvement workforce and its in depth community of scientists, clinicians and trade leaders.
This pipeline, which is being superior each internally and thru PureTech’s Based Entities, is comprised of 27 therapeutics and therapeutic candidates, together with two which have obtained each U.S. FDA clearance and European advertising and marketing authorization, as of the date of PureTech’s most not too long ago filed Annual Report and corresponding Kind 6-Okay. All the underlying applications and platforms that resulted on this pipeline of therapeutic candidates have been initially recognized or found after which superior by the PureTech workforce by way of key validation factors based mostly on distinctive insights in immunology and drug improvement.
For extra info, go to www.puretechhealth.com or join with us on Twitter @puretechh.
Cautionary Observe Relating to Ahead-Trying Statements
This press launch accommodates statements which might be or could also be forward-looking statements throughout the which means of the Non-public Securities Litigation Reform Act of 1995. All statements contained on this press launch that don’t relate to issues of historic truth must be thought of forward-looking statements, together with with out limitation statements that relate to the enterprise mixture settlement between Gelesis and Capstar Particular Objective Acquisition Corp. (NYSE: CPSR) or issues associated thereto, the potential of GS200 to grow to be a foundational remedy, and Gelesis’ future prospects, improvement plans, and techniques. The forward-looking statements are based mostly on present expectations and are topic to identified and unknown dangers, uncertainties and different vital components that might trigger precise outcomes, efficiency and achievements to vary materially from present expectations, together with, however not restricted to, these dangers, uncertainties and different vital components described below the caption “Threat Elements” in our Annual Report on Kind 20-F for the yr ended December 31, 2021 filed with the SEC and in our different regulatory filings. These forward-looking statements are based mostly on assumptions relating to the current and future enterprise methods of the Firm and the setting through which it can function sooner or later. Every forward-looking assertion speaks solely as on the date of this press launch. Besides as required by regulation and regulatory necessities, we disclaim any obligation to replace or revise these forward-looking statements, whether or not because of new info, future occasions or in any other case.
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