GLY-200 for Duodenal Exclusion (GLYDE Study): Effects of GLY-200 on plasma glucose concentrations, gastric emptying, small intestinal transit, glucose absorption (3-OMG), and insulin and gut hormones after a high carbohydrate semi-solid meal in healthy humans and people with uncomplicated type 2 diabetes.

Start Date01 Oct 2024

Sponsor / Collaborator

University of Adelaide

NCT06259981 / Active, not recruitingPhase 2

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of GLY-200 in Participants With Obesity

This study will evaluate the efficacy, safety, and tolerability of GLY-200 in participants with obesity.

Start Date20 May 2024

Sponsor / Collaborator

Glyscend, Inc.Startup

NCT05478525 / CompletedPhase 2

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamic Effects of GLY-200 in Type 2 Diabetic Patients

This study is a Phase 2, randomized, double-blind, placebo-controlled, single-center study in adult patients with type 2 diabetes. It will evaluate the safety and tolerability of oral GLY-200. Subjects will participate in a ≤ 18-day screening period followed by a metformin washout period of approximately 14 days, and an inpatient period of 16 days. Approximately 48 subjects will be randomized to 1 of 3 active treatment groups or 1 of 3 placebo groups. Dosing will occur for 14 days. A follow-up clinic visit will occur on Day 21 [End of Study (EOS)] or Early Termination (ET).

Start Date03 Aug 2022

Sponsor / Collaborator

Glyscend, Inc.Startup

100 Clinical Results associated with GLY-200

100 Translational Medicine associated with GLY-200

100 Patents (Medical) associated with GLY-200

Literatures (Medical) associated with GLY-200

01 Jul 2024·Bioprocess and Biosystems Engineering

Effect of loading rate and pH on glycerol fermentation and microbial population in an upflow anaerobic filter reactor

Article

Author: Kato, Mario T ; Cordeiro, Cândida N ; Rojas, Patricia ; Sanz, José Luis ; Florencio, Lourdinha ; Veras, Shyrlane T S

AbstractA reactor with silicone tubes as support medium was used for glycerol fermentation. The experimental set-up consisted of three phases. In P1, the applied glycerol loading rate (gly-LR) was in the range of 6–10 g.L−1.d−1 at an influent pH of 7.9 ± 0.4. In P2, gly-LR was kept constant (18.0 ± 1.8 g.L−1.d−1) with different doses of NaHCO3. Finally in P3, two different gly-LR (9 and 18 g.L−1.d−1) were evaluated, dosing 1 g-NaHCO3 per g-COD of glycerol. Glycerol consumption was close 90%. The main end-product was 1,3-propanediol (1,3-PDO) (0.40 mol.mol-gly−1), but ethanol was also generated, particularly at pH above 8 and low gly-LR (0.20 mol.mol-gly−1). After 1-year operation with glycerol as the only carbon source, a drastic shift in the bacterial community was observed. The 1,3-PDO producers Lacrimispora and Clostridium became dominant, although non-glycerol-degrading fermentative genera, e.g., Actinomyces and Eubacterium, thrived at the expense of cellular breakdown products.Graphical abstract

01 Mar 2024·Heliyon

Untargeted metabolomics uncovers metabolic dysregulation and tissue sensitivity in ACE2 knockout mice

Article

Author: Cao, Xi ; Zhao, Lili ; Ji, Wenyi ; Yang, Weili ; Pan, Qiuyue ; Yang, Jinkui

Angiotensin-converting enzyme 2 (ACE2) polymorphisms are associated with increased risk of type 2 diabetes mellitus (T2DM), obesity and dyslipidemia, which have been determined in various populations. Consistently, ACE2 knockout (ACE2 KO) mice display damaged energy metabolism in multiple tissues, especially the key metabolic tissues such as liver, skeletal muscle and epididymal white adipose tissue (eWAT) and show even more severe phenotype under high-fat diet (HFD) induced metabolic stress. However, the effects of ACE2 on global metabolomics profiling and the tissue sensitivity remain unclear. To understand how tissues independently and collectively respond to ACE2, we performed untargeted metabolomics in serum in ACE2 KO and control wild type (WT) mice both on normal diet (ND) and HFD, and in three key metabolic tissues (liver, skeletal muscle and eWAT) after HFD treatment. The results showed significant alterations in metabolic profiling in ACE2 KO mice. We identified 275 and 168 serum metabolites differing significantly between WT and ACE2 KO mice fed on ND and HFD, respectively. And the altered metabolites in the ACE2 KO group varied from 90 to 196 in liver, muscle and eWAT. The alterations in ND and HFD serum were most similar. Compared with WT mice, ACE2 KO mice showed an increase in N-phenylacetylglutamine (PAGln), methyl indole-3-acetate, 5-hydroxytryptophol, cholic acid, deoxycholic acid and 12(S)-HETE, while LPC (19:0) and LPE (16:1) decreased. Moreover, LPC (20:0), LPC (20:1) and PC (14:0e/6:0) were reduced in both ND and HFD serum, paralleling the decreases identified in HFD skeletal muscle. Interestingly, DL-tryptophan, indole and Gly-Phe decreased in both ND and HFD serum but were elevated in HFD liver of ACE2 KO mice. A low level of l-ergothioneine was observed among liver, muscle, and epididymal fat tissue of ACE2 KO mice. Pathway analysis demonstrated that different tissues exhibited different dysregulated metabolic pathways. In conclusion, these results revealed that ACE2 deficiency leads to an overall state of metabolic distress, which may provide a new insight into the underlying pathogenesis in metabolic disorders in both ACE2 KO mice and in patients with certain genetic variant of ACE2 gene.

01 Sep 2023·Diabetes, obesity & metabolism

First-in-human study of a pharmacological duodenal exclusion therapy shows reduced postprandial glucose and insulin and increased bile acid and gut hormone concentrations.

Article

Author: Petersen, John S ; Rayner, Christopher K ; Vora, Jiten ; Colbert, Kevin ; Jozefiak, Thomas H ; Bryant, Christine L N ; Wabnitz, Paul ; Nimgaonkar, Ashish ; Fineman, Mark S ; Horowitz, Michael

AIMSTo address the need for noninvasive alternatives to metabolic surgery or duodenal exclusion devices for the management of type 2 diabetes (T2D) and obesity by developing an orally administered therapeutic polymer, GLY-200, designed to bind to and enhance the barrier function of mucus in the gastrointestinal tract to establish duodenal exclusion noninvasively.MATERIALS AND METHODSA Phase 1, randomized, double-blind, placebo-controlled, single- (SAD) and multiple-ascending-dose (MAD) healthy volunteer study was conducted. In the SAD arm, four cohorts received a single dose of 0.5 g up to 6.0 g GLY-200 or placebo, while in the MAD arm, four cohorts received 5 days of twice-daily or three-times-daily dosing (total daily dose 2.0 g up to 6.0 g GLY-200 or placebo). Assessments included safety and tolerability (primary) and exploratory pharmacodynamics, including serum glucose, insulin, bile acids and gut hormones.RESULTSNo safety signals were observed; tolerability signals were limited to mild to moderate dose-dependent gastrointestinal events. In the MAD arm (Day 5), reductions in glucose and insulin and increases in bile acids, glucagon-like peptide-1, peptide YY and glicentin, were observed following a nonstandardized meal in subjects receiving twice-daily dosing of 2.0 g GLY-200 (N = 9) versus those receiving placebo (N = 8).CONCLUSIONSGLY-200 is safe and generally well tolerated at doses of ≤2.0 g twice daily. Pharmacodynamic results mimic the biomarker signature observed after Roux-en-Y gastric bypass and duodenal exclusion devices, indicating a pharmacological effect in the proximal small intestine. This study represents the first clinical demonstration that duodenal exclusion can be achieved with an oral drug and supports further development of GLY-200 for the treatment of obesity and/or T2D.

News (Medical) associated with GLY-200

03 Jun 2024

·www.biospace.com

Glyscend Doses First Patient in a Phase 2 Obesity Trial of GLY-200, a First-in-Class Oral Polymeric Drug Candidate for the Treatment of Metabolic Disease

Study to assess weight-loss and evaluate safety and tolerability of GLY-200 after 16-weeks oral treatment in a non-diabetic obese population GLY-200 designed to alter metabolic signaling in the gut, mimicking the beneficial duodenal exclusion effects of bariatric surgery with an oral drug Phase 2 results expected in the first quarter of 2025 BOSTON--(BUSINESS WIRE)-- Glyscend Therapeutics, a clinical-stage biopharmaceutical company advancing first-in-class oral polymeric drugs for the treatment of metabolic disease, today announced the initiation of a Phase 2 clinical trial of its lead candidate, GLY-200, as a novel oral treatment for obesity. GLY-200 previously demonstrated clinically meaningful reductions in fasting and postprandial glucose, fasting lipids, body weight, food intake, and appetite versus placebo in a completed two-week study in patients with type 2 diabetes and was also shown to be well-tolerated with no treatment-related safety signals. This ongoing Phase 2 trial is designed to evaluate the efficacy, safety, and tolerability of GLY-200 in a non-diabetic obese population. Obesity and type 2 diabetes affect hundreds of millions of people who need well-tolerated and effective ways to manage their disease. While metabolic (bariatric) surgery is one such effective approach, it is an invasive and expensive procedure, limiting its therapeutic use and potential. In addition, while injectable incretin therapies are effective, they can have side effects that impact patients’ ability to stay on therapy long-term. Today, there remains a significant need for well-tolerated oral therapies with differentiated mechanisms that offer long-term efficacy alone and in combination with currently available options. “Advancing GLY-200 into this Phase 2 obesity trial marks another major milestone for Glyscend as we seek to bring innovative oral therapies to patients with metabolic disease,” said Sapan Shah, Ph.D., chief executive officer of Glyscend. “Building on previous clinical data in patients with diabetes, we believe GLY-200 may also provide meaningful weight-loss benefit and a well-tolerated pro patients with obesity. Given its unique mechanism of oral pharmacologic duodenal exclusion, GLY-200 has the potential to be complementary to existing treatments and could expand the therapeutic arsenal needed to treat the global obesity epidemic.” GLY-200 is a first-in-class, orally administered, non-absorbed polymeric drug that was designed to target and enhance the natural mucus barrier of the duodenum in the upper small intestine. The duodenal epithelium acts as a nutrient sensing and metabolic signaling center and has been shown to undergo morphological changes and become dysfunctional in patients with metabolic disease, including obesity and type 2 diabetes. The enhanced mucus barrier in the duodenum created by GLY-200 is intended to restore and activate beneficial gut-mediated signaling through multiple downstream metabolic pathways, including enhanced release of GLP-1 and PYY, thereby reproducing many of the beneficial effects of bariatric surgery in a non-invasive oral pharmacologic duodenal exclusion approach. In the ongoing 16-week Phase 2 clinical trial, approximately 70 participants with a BMI between 32 and 40 mg/kg2 will be randomized to receive either 2.0 g GLY-200 or placebo twice-daily for 16 weeks. The primary outcome measures will be percent change in body weight from baseline and the proportion of participants who achieve ≥ 5% body weight reduction at Week 16. Additional outcome measures include safety and tolerability, waist circumference, and glycemic and lipid parameters. Enrollment is underway at five sites across the US, and Glyscend anticipates results from the Phase 2 trial in the first quarter of 2025. Additional trial details can be found by visiting ClinicalTrials.gov. About Glyscend, Inc. Glyscend Therapeutics is a clinical-stage biopharmaceutical company that is taking a novel approach to the treatment of metabolic disease, led by obesity and type 2 diabetes (T2D), with first-in-class oral polymeric drugs that have the potential to address significant unmet needs for patients globally. The company’s lead candidate, GLY-200, is designed to be non-absorbed and selectively target and bind to the mucus lining of the upper GI tract, where it can modulate nutrient sensing and downstream metabolic signaling pathways. Based on its unique mechanism of action, GLY-200 is intended to mimic the beneficial effects of metabolic surgery and duodenal exclusion devices. In a Phase 2a study in patients with T2D, GLY-200 was well-tolerated and demonstrated clinical proof-of-concept, with statistically significant improvements on glycemic control and body weight as well as potential beneficial effects on other metabolic markers. Glyscend plans to advance GLY-200 into longer term Phase 2b studies in patients with obesity and T2D. The company is backed by healthcare innovators, Santé Ventures and Brandon Capital Partners, and was founded based on research and funding from Johns Hopkins University, the Thiel Foundation and Breakout Labs. For more information, please visit .

Phase 2Clinical Result

08 Sep 2023

·endpts.com

Glyscend taps CEO to lead oral obesity, type 2 diabetes candidate; Ex-Travecta chief bounces back after company shutdown

As a new wave of type 2 diabetes and obesity drugs takes the industry by storm, Glyscend Therapeutics has tapped a new CEO to lead the charge for its candidate designed to mimic metabolic surgery. Sapan Shah is taking the driver’s seat at Glyscend as founding CEO Ashish Nimgaonkar shifts to other roles as chief medical officer and head of R&D, the company announced on Tuesday. The news comes just a few months after Glyscend unveiled topline data from a Phase IIa suggesting its lead candidate, GLY-200 , helped type 2 diabetes patients achieve significant reductions in blood glucose and a decrease in body weight. The company hopes the oral drug will have the same effects as metabolic surgery without the cost and complications from the invasive procedure.

Phase 2Executive Change

05 Sep 2023

·www.biospace.com

Glyscend Therapeutics Appoints Sapan A. Shah, Ph.D., Accomplished Industry Executive, as Chief Executive Officer

Planned Leadership Transition to Accelerate the Company’s Next Stage of Growth; Founding CEO Ashish Nimgaonkar, M.D., Transitions to Chief Medical Officer and Head of R&D Lead Candidate, GLY-200, Ready to Begin Phase 2b Development for Obesity and Type 2 Diabetes BOSTON--(BUSINESS WIRE)-- Glyscend Therapeutics, a clinical-stage biopharmaceutical company that is reshaping the treatment of metabolic disease, including obesity and type 2 diabetes, with first-in-class oral polymer medicines that address unmet needs for patients globally, today announced the appointment of Sapan Shah, Ph.D., as Chief Executive Officer. Dr. Shah has more than 25 years of experience leading innovative life science companies as CEO, founder, board member and strategic advisor. His appointment is part of a planned leadership transition to accelerate Glyscend’s growth as it further advances lead product candidate, GLY-200, a clinical stage oral polymer medicine targeting gut mediated metabolic signaling. In conjunction with the transition, founding CEO, Ashish Nimgaonkar, M.D., was appointed to the newly created role of Chief Medical Officer and Head of Research and Development. “I am thrilled to welcome Sapan to the team and excited to partner with him through the next phase of Glyscend’s growth. I also want to commend the entire Glyscend team for their dedication and efforts in getting the company to its current stage,” stated Dr. Nimgaonkar. “GLY-200 is well-positioned to advance into a Phase 2b trial for patients with obesity and type 2 diabetes, and I look forward to collaborating with Sapan to progress our lead program and bring forward additional therapies for patients living with metabolic diseases.” “Under Ashish’s leadership, Glyscend has made tremendous progress going from scientific hypothesis to clinical proof-of-concept in a positive Phase 2a trial. His insights across our clinical and research portfolio will be crucial to our continued success,” said Dennis McWilliams, Partner at Santé Ventures and Chair of Glyscend’s Board of Directors. “We are delighted to bring in Sapan at this pivotal time, with his deep experience in executing financings, business development deals and operational buildouts for development-stage companies. Together with our existing leadership, we have a clear path toward execution of our near- and long-term goals.” Dr. Shah has significant leadership experience in the biopharma industry, with a focus on building, financing and operating innovative companies advancing novel therapeutics that address critical areas of unmet medical need. His previous CEO roles have included StrideBio, a leading developer of novel adeno-associated virus (AAV) based gene therapies with a pioneering structure-driven capsid engineering platform that was acquired by Gingko Bioworks in 2023; ARMGO Pharma, a clinical-stage company advancing treatments for debilitating cardiac and rare muscle diseases; Ezose Sciences, a high-throughput glycomics platform company acquired by Sumitomo Bakelite in 2014; and Shionogi Inc., the U.S. pharmaceutical business of Shionogi & Co, Ltd. At StrideBio, Dr. Shah led efforts to expand the company’s capabilities and pipeline, execute multiple pharmaceutical partnerships and close a Series B financing with a top venture syndicate. At Shionogi, Dr. Shah launched the company’s initial U.S. business, ultimately building a fully integrated clinical development and commercial organization, including overseeing development programs and marketed products in the obesity and diabetes area. Dr. Shah began his career as a consultant with McKinsey & Company, where he advised pharmaceutical and biotech clients on a wide range of R&D, commercial and corporate strategy initiatives. Dr. Shah holds a Ph.D. in Molecular Biophysics and Biochemistry from Yale University and B.A. degrees in Mathematics, Biochemistry and Integrated Science from Northwestern University. “I am grateful for the opportunity to build on the fantastic progress made by Ashish and the entire Glyscend team, and to lead the next phase of growth. This is a transformative time for obesity and type 2 diabetes patients with current therapies showing remarkable results. However, significant unmet needs persist with large numbers of patients remaining uncontrolled or unable to tolerate available treatments. Given the magnitude of the global obesity-diabetes epidemic, new oral therapies with mechanisms of action that are complementary to existing approaches are urgently needed,” said Dr. Shah. “Based on recent Phase 2a clinical results, GLY-200 has the potential to offer obesity and type 2 diabetes patients an oral, well-tolerated and effective therapy. I look forward to working alongside the Glyscend team and Board to bring this important medicine to patients.” About Glyscend, Inc. Glyscend Therapeutics is a clinical-stage biopharmaceutical company that is reshaping the treatment of metabolic disease, led by obesity and type 2 diabetes (T2D), with first-in-class oral polymer medicines with the potential to address significant unmet needs for patients globally. The company’s lead candidate, GLY-200, is designed to be non-absorbed and selectively target and bind to the inner lining of the upper GI tract, where it can modulate nutrient sensing and downstream metabolic signaling pathways. Based on its unique mechanism of action, GLY-200 mimics the beneficial effects of metabolic surgery and duodenal exclusion devices. In a Phase 2a study in patients with T2D, GLY-200 was well-tolerated and demonstrated clinical proof-of-concept, with statistically significant improvements on glycemic control and body weight as well as potential beneficial effects on other metabolic markers. Glyscend plans to advance GLY-200 into longer term Phase 2b studies in patients with obesity and T2D. The company is backed by healthcare innovators, Santé Ventures and Brandon Capital Partners, and was founded based on research and funding from Johns Hopkins University, the Thiel Foundation and Breakout Labs. For more information, please visit .

Phase 2Executive ChangeAcquisitionClinical Result

100 Deals associated with GLY-200

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Obesity	Phase 2	US	Glyscend, Inc.Startup	20 May 2024
Diabetes Mellitus, Type 2	Phase 2	US	Glyscend, Inc.Startup	03 Aug 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05478525 (ADA2024) Manual	Phase 2	Diabetes Mellitus, Type 2	51	GLY-200 0.5g	(zadlgelpuf) = ydsbfcehfa dhauyycnmn (ohkhikwwta ) View more	Positive	20 Jun 2024
NCT05478525 (ADA2024) Manual	Phase 2	Diabetes Mellitus, Type 2	51	GLY-200 1.0g	(zadlgelpuf) = lfmsiohise dhauyycnmn (ohkhikwwta ) View more	Positive	20 Jun 2024
NAASO2022	Phase 1	-	-	GLY-200	eectzknczp(ffmwtqywsd) = ltnpxbkokj yjrytextqw (xvxwlevsii )	-	21 Nov 2022
Biospace Manual	Phase 1	Diabetes Mellitus, Type 2	64	GLY-200	(dcfgylrkfg) = GLY-200 was well-tolerated with no safety signals observed cxlwntmhmz (wrrzbcmuix )	Positive	20 Sep 2022

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