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First Patient, First Visit in Phase 3 Clinical Trial of Vezocolmitide for Dry Eye Disease

STUART, Fla., Dec. 29, 2023. Stuart Therapeutics, Inc. ("Stuart"), a clinical stage biopharmaceutical company conducting research and development of unique extracellular matrix-targeting peptide therapeutics for ophthalmic diseases, today announced the First Patient First Visit (FPFV) for the company's Phase 3 clinical trial of ST-100 (vezocolmitide), in Dry Eye Disease patients. The Phase 3 multi-center, randomized, double masked, placebo controlled study to assess the safety and efficacy of ST-100 ophthalmic solution in subjects diagnosed with Dry Eye Disease, will evaluate a single dose level versus placebo. The company will enroll 320 volunteers in the study. Vezocolmitide is the first drug candidate based on PolyCol™ (PolyCol), the company's patented synthesized polypeptide collagen mimetic peptide platform

"Stuart Therapeutics is pleased to announce this important milestone in the company's evolution," said Eric Schlumpf, President & CEO of Stuart. "Since the completion of our Phase 2 trial with ST-100, we have significantly expanded our portfolio, based on new research results on our mechanism of action, and its applicability to a number of important indications in ophthalmology. In particular, our findings, coupled with the endpoint outcomes in our Phase 2 trial suggest the potential for a fast acting, highly differentiated treatment for dry eye that can offer improved tear production, symptom relief, reduction in ocular surface damage and improvement in visual acuity. We believe that vezocolmitide has the potential to solve the major unmet need for a fast and effective topical therapeutic that treats a broad range of Dry Eye Disease patients."

PolyCol is a platform technology comprised of synthesized polypeptides that mimic key amino acid sequences found in extracellular matrix (ECM) collagen in the body. The mechanism of action is the rapid restoration of disease-damaged helical collagen, resulting in ECM structural repair and restoration of normal cell signaling activity, including reduction in inflammation. Pre-clinical research has shown a restoration of the corneal sub-basal nerve plexus, and a beneficial effect on nerve processes and epithelial cells, all of which are implicated in dry eye disease. Stuart controls the worldwide rights for the PolyCol technology platform in ophthalmology therapeutics.

About Stuart Therapeutics

Stuart Therapeutics, founded in 2017 and based in Stuart, Florida, is the leader in the development of ECM-targeting therapeutics for disease treatment. Its platform technology, PolyCol™, is a patented portfolio of synthesized collagen mimetic peptides designed to specifically bind to and repair disease- or injury-damaged helical collagen structures. This activity results in both a repair of collagen structures and a restoration of homeostatic cell signaling, with positive effects on cell growth and proliferation and reduction in inflammation. These effects occur rapidly in treated tissues, as demonstrated by the results of extensive research conducted by Stuart Therapeutics in a variety of anterior and posterior segment ophthalmic disease indications.

SOURCE Stuart Therapeutics

Posted: December 2023

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