Glycologix to Present Phase 1b Clinical Trial Data for GLX-100 at American Urological Association (AUA) 2025 Annual Meeting

Glycologix, Inc. (“Glycologix”), a clinical-stage company developing biopolymers for the protection and repair of soft tissues, announced that clinical results from its multi-center, Phase 1b study of GLX-100 in Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) will be presented at the American Urological Association (AUA) 2025 Annual Meeting in Las Vegas, Nevada.

Podium presentation details:

• Title: A Phase 1b, First-in-Human, Open-label, Single-Arm Study Evaluating the Safety and Efficacy of GLX-100, a Novel Synthetic Glycosaminoglycan Replacement Therapy in Subjects with Interstitial Cystitis/Bladder Pain Syndrome
• Presentation Number: PD03-04
• Presentation Date/Time: Saturday, April 26, 2025, at 7:24 AM
• Presenter: Dr. Jeffrey Proctor
• Location: Venetian Expo Center, Galileo 1001

IC/BPS affects approximately 10 million people in the U.S., predominantly women.^1,2 It is a urological disorder that often compromises the integrity of the natural protective barrier layer of the bladder wall, resulting in pain and pressure in the bladder/pelvic area and urinary frequency, urgency and nocturia. GLX-100 is a novel synthetic intravesical biopolymer which has been designed to closely replicate the natural bladder protective barrier layer and relieve the symptoms of IC/BPS. Based on the data from this Phase 1b trial, Glycologix is planning a phase 2b study with GLX-100.

Commenting on the trial results, Grannum R Sant, MD, said, “This first in human clinical trial demonstrates early promise for the safety and efficacy of GLX-100 in the treatment if IC/BPS, a condition for which clinicians currently have limited treatment options with no U.S. FDA product approvals in nearly 30 years.”

About Glycologix

Glycologix, Inc. is an emerging company dedicated to the development and commercialization of rationally designed biopolymers for the protection and repair of soft tissues. The company’s lead program, GLX-100, is in development as a novel intravesical therapy for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), a debilitating urological condition affecting approximately 10 million in the US.^1,2 . For more information, visit www.glycologix.com.

Forward-Looking Statements

This press release discusses investigational uses of a treatment in development and is not intended to convey conclusions about safety or effectiveness. There is no guarantee that the therapy described will successfully complete development or receive regulatory approval.

References:

1. Berry, SH. J Urol 2011; 186:540-4.
2. Suskind, AM. J Urol 2013; 189(1):141-5.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250423241939/en/

Study results set the stage for Phase 2b trial.