STUART, Fla., Dec. 29, 2023 /PRNewswire/ -- 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.

佛罗里达州斯图尔特，2023年12月29日/PRNewswire/-STUART Therapeutics，Inc.（“斯图尔特”）是一家临床阶段的生物制药公司，负责研究和开发针对眼科疾病的独特细胞外基质靶向肽疗法，今天宣布该公司在干眼病患者中进行ST-100（vezocolmitide）3期临床试验的首次患者首次就诊（FPFV）。

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..

第三阶段多中心，随机，双盲，安慰剂对照研究评估ST-100眼科溶液在诊断为干眼症的受试者中的安全性和有效性，将评估单剂量水平与安慰剂的比较。该公司将招募320名志愿者参加这项研究。Vezocolmitide是第一个基于PolyCol的候选药物™ （PolyCol），该公司获得专利的合成多肽胶原模拟肽平台。。

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Stuart Therapeutics Initiates Phase 3 Dry Eye Disease Clinical Trial

Stuart Therapeutics启动3期干眼病临床试验

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Stuart, Florida

佛罗里达州斯图尔特

'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.

斯图尔特总裁兼首席执行官埃里克·施伦普夫（EricSchlumpf）说，斯图尔特治疗公司很高兴宣布公司发展过程中的这一重要里程碑自ST-100完成第二阶段试验以来，我们根据有关作用机制的新研究结果及其对眼科许多重要适应症的适用性，大大扩展了我们的投资组合。

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.'.

特别是，我们的研究结果，加上我们第二阶段试验的终点结果，表明干眼症可能有一种快速，高度分化的治疗方法，可以改善泪液的产生，缓解症状，减少眼表损伤和提高视力。我们认为，vezocolmitide有可能解决尚未满足的主要需求，即快速有效的局部治疗方法，可治疗广泛的干眼症患者。”。

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.

PolyCol是一种平台技术，由模拟体内细胞外基质（ECM）胶原蛋白中关键氨基酸序列的合成多肽组成。其作用机制是快速恢复疾病受损的螺旋胶原蛋白，从而导致ECM结构修复和恢复正常的细胞信号传导活性，包括减少炎症。

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..

临床前研究表明，角膜基底下神经丛的恢复，以及对神经过程和上皮细胞的有益作用，所有这些都与干眼症有关。斯图尔特控制着PolyCol眼科治疗技术平台的全球权利。。

About Stuart TherapeuticsStuart 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.

关于Stuart Therapeutics Stuart Therapeutics成立于2017年，总部位于佛罗里达州斯图尔特，是开发针对疾病治疗的ECM靶向疗法的领导者。Its平台技术PolyCol™, 是合成胶原模拟肽的专利组合，旨在特异性结合并修复疾病或损伤受损的螺旋胶原结构。

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.

这种活性导致胶原结构的修复和稳态细胞信号的恢复，对细胞生长和增殖以及炎症的减少具有积极作用。Stuart Therapeutics在各种前后段眼科疾病适应症中进行的广泛研究结果表明，这些作用在治疗过的组织中迅速发生。

For more information, visit www.stuarttherapeutics.com.Contact:Eric SchlumpfPresident & CEO206-228-2781[email protected]SOURCE Stuart Therapeutics.

欲了解更多信息，请访问www.stuartherapetics.com。联系人：Eric SchlumpfPresident＆CEO206-228-2781[受电子邮件保护]来源Stuart Therapeutics。