Stuart Therapeutics Completes Phase 3 Trial of Vezocolmitide for Dry Eye Disease
Stuart Therapeutics has announced the successful completion of its Phase 3 clinical trial for ST-100 (vezocolmitide), its lead therapeutic candidate for the treatment of dry eye disease (DED). This milestone marks a significant step forward in the development of a novel therapeutic approach for patients suffering from this widespread condition.
Overview of the Phase 3 Trial
The Phase 3 trial was a randomized, double-blind, vehicle-controlled study designed to evaluate the:
• Efficacy
• Safety
• Tolerability
Patients received either ST-100 or placebo for one month, followed by a two-week observation period. The trial, initially launched in December 2023 at one U.S. site, was later expanded to multiple locations in Australia.
About ST-100 (Vezocolmitide)
ST-100 features vezocolmitide, a patented collagen mimetic peptide that selectively repairs collagen damaged by disease in the eye.
Preclinical Insights
In preclinical research, collagen mimetic peptides demonstrated:
• Improved Cell Health: Benefits for epithelial, neuronal, and endothelial cells.
• Anti-Inflammatory Effects: Reduction in inflammation and oxidative stress.
Phase 2 Findings
In its Phase 2 clinical trial, ST-100 showed:
• Rapid Relief: Noticeable improvement in symptoms within 28 days.
• Patient Comfort: High tolerability.
• Enhanced Tear Function: Significant improvements in tear production and quality.
What’s Next?
Topline data from the Phase 3 trial is expected to be released in February 2025, providing critical insights into the potential of ST-100 to address unmet needs in dry eye disease treatment.
Leadership Perspective
Eric Schlumpf, President & CEO of Stuart Therapeutics, highlighted the significance of this achievement:
“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.
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.”
A New Drug Class for Ophthalmology
ST-100 represents an innovative therapeutic approach for dry eye disease, with potential applications for additional ophthalmic conditions. Its unique mechanism of action, targeting collagen repair and reducing inflammation, may set a new standard in treating chronic eye diseases.
Conclusion
As Stuart Therapeutics moves closer to delivering a breakthrough therapy for dry eye disease, the upcoming Phase 3 results will play a pivotal role in determining the future of ST-100 and its potential to redefine the treatment landscape for ophthalmology.
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