Multi-center clinical study designed to evaluate safety, tolerability and effectiveness of a novel biopolymer device.

BEVERLY, Mass. & MELBOURNE, Australia--(BUSINESS WIRE)--Glycologix, Inc. (“Glycologix”), a clinical-stage company focused on developing biopolymers for the protection and repair of soft tissues, today announced the treatment of the first patient in a pilot clinical study evaluating GLX-100 as a novel treatment for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). The multi-center pilot trial is designed to assess the safety, tolerability and effectiveness of GLX-100 in participants with IC/BPS and is expected to enroll up to 40 women with results anticipated in 2024.

IC/BPS is a urological disorder that often compromises the integrity of the inner bladder wall lining, resulting in intense pain and pressure in the bladder often accompanied by urinary frequency, urgency and nocturia. GLX-100 is a novel biopolymer, which has been designed to closely replicate the natural protective barrier layer and relieve the symptoms of IC/BPS.

IC/BPS affects approximately 10 million people in the U.S., predominantly women.^1,2 However, currently available treatment options often fail to manage the symptoms and no new treatments have been approved in the US since 1996.

Commenting on the initiation of the clinical study, Professor Anna Rosamilia, Principal Investigator at Melbourne’s Monash University said, “Options for treating IC/BPS today are quite limited and this important trial provides an exciting opportunity to evaluate the potential of GLX-100 to improve the lives of patients in desperate need of new and better treatment options. We look forward to sharing the results from the study in 2024.”

About Glycologix

Glycologix, Inc. is an emerging company dedicated to development and commercialization of rationally designed biopolymers for the protection and repair of soft tissues. Glycologix technology can target significant unmet medical needs and major market opportunities. Glycologix’ lead program is focused on GLX-100 for the treatment of IC/BPS. For more information, visit www.glycologix.com.

References

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

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 listed in this release will successfully complete development or gain regulatory authorizations or approvals.

Contacts

Dan Deardorf, CEO, [email protected] or 617-480-2536