Stuart Therapeutics Unveils Breakthrough Phase 3 Clinical Trial for Vezocolmitide, a Potential Game-Changer in Dry Eye Disease Treatment

Stuart Therapeutics, Inc. (“Stuart”), a cutting-edge biopharmaceutical company specializing in extracellular matrix-targeting peptide therapeutics for ophthalmic diseases, has marked a significant milestone with the initiation of the First Patient First Visit (FPFV) in its Phase 3 clinical trial of ST-100 (vezocolmitide) for Dry Eye Disease.

The Phase 3 trial, a multi-center, randomized, double-masked, placebo-controlled study, aims to evaluate the safety and efficacy of ST-100 ophthalmic solution in patients diagnosed with Dry Eye Disease. The study, comparing a single dose level to a placebo, will enroll 320 volunteers. Vezocolmitide stands as the pioneering drug candidate derived from PolyCol™ (PolyCol), Stuart’s revolutionary synthesized polypeptide collagen mimetic peptide platform.

Eric Schlumpf, President & CEO of Stuart, expressed enthusiasm for this critical development, stating, “Stuart Therapeutics is pleased to announce this important milestone in the company’s evolution. 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.”

He added, “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, Stuart’s groundbreaking platform technology, consists of synthesized polypeptides mimicking key amino acid sequences found in extracellular matrix (ECM) collagen. The mechanism of action involves the rapid restoration of disease-damaged helical collagen, leading to ECM structural repair and the restoration of normal cell signaling activity, including a reduction in inflammation. Pre-clinical research has demonstrated positive effects on the corneal sub-basal nerve plexus and beneficial impacts on nerve processes and epithelial cells, all crucial factors in dry eye disease. Stuart holds worldwide rights for the PolyCol technology platform in ophthalmology therapeutics.

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