Stuart Therapeutics Announces Completion of Phase 3 Dry Eye Disease Clinical Trial

STUART, Fla., Jan. 21, 2025 /PRNewswire/ -- Stuart Therapeutics, Inc. (Stuart), a clinical-stage drug platform company developing novel therapies for ophthalmic diseases, today announced last patient last visit in the phase III study of its lead therapeutic candidate ST-100 (vezocolmitide) for treatment of Dry Eye Disease. Topline data results are expected in February 2025.

"We are pleased to announce the completion of this important milestone for Stuart Therapeutics and offer our congratulations to our study team.  Stuart continues to advance the development of this new drug class for treatment of multiple indications in ophthalmology," said Eric Schlumpf, President & CEO of Stuart.

"We want to express our appreciation to all patient participants, collaborators and investigators, whose contributions enabled the completion of this study.  Our team now shifts its focus to the evaluation of the data to meet our goal of sharing the topline results during the first quarter of 2025."

About the Phase III Trial
This study is a phase III, randomized, double-blind, vehicle-controlled trial investigating the efficacy, safety, and tolerability of ST-100 (vezocolmitide) for treatment of Dry Eye Disease. Patients were treated with ST-100 or placebo for one month, followed by a two-week observation period.  The study was initiated in December of 2023 at one site in the United States and completed at multiple sites in Australia.  

About ST-100 (Vezocolmitide)
ST-100 (vezocolmitide) is a patented formulation comprising vezocolmitide, a collagen mimetic peptide that selectively repairs disease- damaged collagen in the eye.   This repair provides both restoration of the collagen matrix and structures in the eye and homeostatic cell signaling by those structures.  In its preclinical research, Stuart has shown that collagen mimetic peptides induce improvements in cell health and function in epithelial, neuronal and endothelial cells and tissues containing such cells, and reductions in inflammation and oxidative stress.  These factors are critical in Dry Eye Disease, which is a multi-factorial ocular disorder suffered by millions of patients worldwide and that involves ocular surface damage, inflammation, and damage to corneal nerves, all of which result in patient discomfort, blurred vision, and difficulty with activities of daily life.  Based on findings by Stuart in a Phase 2 clinical trial (Baratta, R.O. et al., Ophthalmol. Sci. 4(3):100451 (2024)), ST-100 appears to provide rapid relief, is comfortable for patients, and provides improvement in tear function within 28 days, unlike other currently commercialized Dry Eye Disease drugs.

About Stuart Therapeutics, Inc.
Headquartered in Stuart, Florida, Stuart Therapeutics, Inc. is a clinical-stage, drug platform company addressing Dry Eye Disease, Glaucoma, Myopia and Retinal Diseases, such as Diabetic Macular Edema. Stuart is the leader in the development of therapeutics targeting the extracellular matrix.

Contacts:
Eric Schlumpf, President & CEO
eric@stuarttherapeutics.com

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SOURCE Stuart Therapeutics