BOSTON--(BUSINESS WIRE)--Glyscend Therapeutics, a clinical-stage biotechnology company pioneering a new generation of orally administered first-in-class gut-targeted polymer therapies, today announced clinical progress with its lead candidate, GLY-200, for the treatment of type 2 diabetes (T2D) and obesity. Data across completed Phase 1 and Phase 2a clinical trials demonstrated that the novel mechanism of GLY-200 offers significant and clinically relevant reductions in postprandial glucose and body weight and support its advancement into a Phase 2b clinical trial.
GLY-200 is a proprietary mucin-complexing polymer designed to enhance the natural mucus barrier in the duodenum (the upper small intestine). This enhanced barrier results in a pharmacologic ‘duodenal exclusion’ intended to non-invasively and safely reproduce many of the beneficial effects of metabolic (bariatric) surgery including improvements in glycemic and bodyweight control. T2D and obesity are worldwide endemics with millions of people in need of more effective ways to manage their disease. While metabolic surgery is considered an effective approach, it is also invasive and expensive for patients, limiting its use as a therapeutic approach.
Glyscend has completed a Phase 2a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability and pharmacodynamic effects of GLY-200, as an adjunct to diet and exercise, in 51 patients with T2D. Patients were administered oral GLY-200 or placebo twice-daily for 14 days with one week follow-up. Data from the study show that GLY-200 treatment resulted in:
- statistically significant reductions in postprandial glucose in response to standardized meals;
- statistically significant reductions in body weight;
- reductions in food intake during ad libitum meals; and
- improvements in appetite assessments during ad libitum meals.
In addition, GLY-200 was well-tolerated with no treatment-related safety signals, and pharmacokinetic data are consistent with a gut-restricted non-absorbed polymer drug.
“Type 2 diabetes and obesity are extremely common chronic diseases where the outcome of most therapeutic options is suboptimal. An exception is bariatric surgery, which is effective, but is also expensive and frequently associated with significant and long-term adverse effects,” said Michael Horowitz, MBBS, PhD, FRACP, Professor of Medicine at the University of Adelaide and Director of the Endocrine and Metabolic Unit at the Royal Adelaide Hospital. “The availability of a new class of medicines which establish duodenal exclusion to non-invasively mimic the desirable, but not the adverse, effects of bariatric surgery would be transformative. I am extremely encouraged by the recent data and eager to see GLY-200 advance through the Phase 2b trial and beyond.”
“We are thrilled with the findings from our Phase 2a trial, which demonstrate, for the first time, evidence of GLY-200’s effects on glycemia and bodyweight in patients with T2D,” said Ashish Nimgaonkar, MD, founder and chief executive officer of Glyscend. “These Phase 2a data provide clinical evidence that duodenal exclusion may be possible with a non-invasive, orally administered, pharmaceutical treatment. We believe GLY-200 has first-in-class potential to offer patients and physicians an additive or alternative option in their diabetes and obesity treatment toolboxes, and we look forward to advancing into Phase 2b.” Dr. Nimgaonkar will speak to gut-mediated mechanisms as potential disease modifying targets for T2D and obesity at the Novel Therapies for Type 2 Diabetes and Obesity Summit being held in Boston from May 31-June 1, 2023.
The Phase 2a data on GLY-200 in patients with T2D adds to our learnings from the Phase 1 single- and multiple-ascending dose clinical trial in 64 healthy volunteers. Data from the Phase 1 trial showed that oral administration of GLY-200 led to positive pharmacodynamic effects, including statistically significant effects on glucose, insulin and bile acids, and was associated with changes in gut hormones such as GLP-1, PYY and glicentin compared to placebo. These results mimicked the biomarker signature observed following metabolic surgery and duodenal exclusion devices indicating a pharmacological effect in the small intestine.
Data from the company’s Phase 1 clinical trial and preclinical studies will be presented during oral and poster sessions at the American Diabetes Association 83rd Scientific Sessions being held in-person and virtually from June 23-26, 2023, in San Diego.
Novel Therapies for Type 2 Diabetes and Obesity Summit Details:
Dr. Nimgaonkar is an invited speaker at the Novel Therapies for Type 2 Diabetes and Obesity Summit being held in Boston from May 31-June 1, 2023. He will discuss therapeutic targets in the gut for the treatment of T2D and obesity.
ADA Presentation Details:
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Presentation Title: (220-OR) First-in-Human Study of a Pharmacological Duodenal Exclusion Therapy Mimics a Roux-en-Y Gastric Bypass Biomarker Signature
Session Title: Treatments New and Old
Session Type: Oral
Session Date/Time: Saturday, June 24, 2023, 4:30-6:00 p.m. PT
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Presentation Title: (823-P) GLY-200, a Pharmacologic Duodenal Exclusion Therapy, Improved Metabolic Parameters in the DIO Rate
Session Title: Novel Elements of Medical and Surgical Therapy
Session Type: ePoster Theater
Session Date/Time: Saturday, June 24, 2023, 12:30-1:30 p.m. PT
Session Title: 12-D Clinical Therapeutics – Other Therapeutic Agents
Session Type: Poster
Session Date/Time: Sunday, June 25, 2023, 11:30 a.m. - 12:30 p.m. PT
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Presentation Title: (833-P) Duodenal Targeting by Oral Pharmacologic Duodenal Exclusion Therapy for Treatment of Type 2 Diabetes (T2D)
Session Title: 12-D Clinical Therapeutics – Other Therapeutic Agents
Session Type: Poster
Session Date/Time: Sunday, June 25, 2023, 11:30 a.m. - 12:30 p.m. PT
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Presentation Title: (832-P) Coadministration of Metformin with GLY-200, a Clinical-Stage Non-absorbed Drug for the Treatment of Type 2 Diabetes (T2D), Has No Significant Impact on the Oral Absorption of Metformin in the Rat
Session Title: 12-D Clinical Therapeutics – Other Therapeutic Agents
Session Type: Poster
Session Date/Time: Sunday, June 25, 2023, 11:30 a.m. - 12:30 p.m. PT
About Type 2 Diabetes and Obesity
Type 2 diabetes (T2D) and obesity are considered global endemics, affecting more than 500 million and 700 million people worldwide, respectively. T2D is characterized by complex metabolic dysfunctions and life-threatening comorbidities, including atherosclerotic disease, retinopathy, neuropathy, chronic inflammation, and an increase in infections, which result in a high morbidity and mortality rate and are associated with expensive treatment costs. Despite availability of many therapeutic options, nearly half of T2D patients have uncontrolled diabetes and even a modest reduction in glucose levels and weight loss have been shown to meaningfully reduce comorbidities and improve health-related outcomes for patients with T2D and/or obesity. Obesity, defined as a body mass index (BMI) of >30 kg/m2, is a significant independent risk factor for T2D. Like T2D, obesity is associated with a range of life-threatening comorbidities, including cardiovascular disease, obstructive sleep apnea, and cancer. In addition, there is clear and consistent evidence that effectively managing obesity can delay the progression from prediabetes to type 2 diabetes. The current standards of care for T2D and obesity begin with lifestyle intervention followed by oral and injectable drugs, and, if non-surgical treatments fail, metabolic surgery is recommended.
None of the currently available treatments are considered disease-modifying, except for metabolic surgery. Metabolic surgery, or bariatric surgery (e.g., gastric bypass), involves surgical exclusion of the first part of the small intestine (the duodenum) and bypass of nutrient absorption in that region. Of all therapeutic interventions for T2D and/or obesity, metabolic surgery has shown the most immediate, profound, and durable effects on improving blood glucose and body weight, with longer-term reductions in microvascular and macrovascular complications. However, while effective, a limited number of patients undergo metabolic surgery due to its significant invasiveness, patient-aversion, post-surgical risks, and high direct-to-patient costs.
About Glyscend, Inc.
Glyscend Therapeutics is a clinical-stage biopharmaceutical company developing novel, orally administered, polymer therapies that work on targets inside the gastrointestinal tract to treat a variety of metabolic and chronic disorders. Polymer-based therapies are a unique class of therapeutics with more than three decades of clinical experience in a wide range of applications. Glyscend’s polymer therapeutic platform evolved out of research at Johns Hopkins University where scientists were evaluating the mechanisms that result in significantly improved glucose and metabolic regulation that precedes weight loss in certain types of metabolic surgery. The company’s lead product candidate, GLY-200, is in clinical development for the treatment of type 2 diabetes and obesity. For more information, please visit www.glyscend.com.
