Glyscend Therapeutics Announces Publication of GLY-200 First-in-Human Data and Availability of Phase 2a Clinical Results

GLY-200 Represents the First Orally Administered Agent for Obesity & Type 2 Diabetes with a Mechanism Designed to Replicate the Effects of Metabolic Surgery and Duodenal Exclusion Devices

GLY-200 Appeared Well-Tolerated in Phase 1 and Phase 2a Trials, with No Safety Signals or Serious Adverse Events Observed Across Multiple Doses Evaluated

Phase 1 and Phase 2a Data Support the Oral Pharmacologic Duodenal Exclusion Approach

Clinical Proof-of-Concept Established in Phase 2a Trial in Patients with Type 2 Diabetes; Phase 2b Trial to be Initiated in the Near Future

BOSTON--(BUSINESS WIRE)--Glyscend Therapeutics, a clinical-stage biotechnology company pioneering a new generation of orally administered first-in-class gut-targeted polymer therapies for the treatment of metabolic diseases including obesity and type 2 diabetes (T2D) today announced that safety and pharmacodynamic data from the first-in-human Phase 1 trial of GLY-200 were published in Diabetes, Obesity and Metabolism. The data published demonstrate that GLY-200, the company’s lead clinical candidate, mimics the biomarker signature seen with metabolic surgery and appeared to be safe and generally well-tolerated. Glyscend also presented additional data from its Phase 2a clinical trial of GLY-200 at the recent American Diabetes Association (ADA) 83^rd Scientific Sessions, which provide clinical proof-of-concept on its ability to reduce glucose and bodyweight in patients with T2D.

Phase 1 First-in-Human Data

As highlighted in the publication, safety and pharmacodynamics were assessed in a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-ascending-dose study in healthy volunteers. No safety signals, serious adverse events, or dose-limiting toxicities were observed. Only mild to moderate dose-dependent gastrointestinal (GI) events occurred, showing that GLY-200 is likely safe and generally well tolerated at doses of ≤2.0 g twice daily. Pharmacodynamic results were consistent with the biomarker signature observed after Roux-en-Y gastric bypass surgery and duodenal exclusion devices making this the first clinical demonstration that duodenal exclusion can be achieved with an orally administered drug.

Phase 2a Proof-of-Concept Data

Data presented at ADA showed that, consistent with the Phase 1 study, no treatment- or dose-related safety signals were observed in the Phase 2a study in patients with T2D. No serious or severe adverse events were reported, and the most common adverse events were constipation, nausea, and diarrhea, all of which were mild. In general, the incidence of GI side effects decreased over time during the 2-week treatment period. Following a standardized meal, incremental plasma glucose AUC was reduced by approximately 45% in subjects receiving 2.0 g GLY-200 twice daily compared to placebo. The same subjects also reported reduced appetite, reduced food intake, and weight loss while on treatment.

“Metabolic surgery is an established efficacious treatment for patients with T2D and obesity; however, its invasive and costly nature hinders its use and it can lead to serious complications in some patients,” said Mark Fineman, Ph.D., Glyscend’s Chief Development Officer and first author on the recent Phase 1 publication. “We are highly encouraged to see the acute clinical benefits of our orally administered first-in-class drug. The totality of the data on GLY-200 suggest it has the potential to replicate the mechanism of surgery and provide a non-invasive alternative to today’s invasive approaches. Given the orthogonal and upstream mechanism of GLY-200, it could be additive to other therapies used to manage these diseases. We are enthusiastic about the level of support we have seen in the patient treatment community and industry for GLY-200 and are working toward initiating a larger and longer Phase 2b trial in patients to more fully profile total body weight loss and HbA1c reduction.”

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.