Lingyi Bio Initiates Clinical Trial of LY-M003 Injection for the Treatment of Wilson's Disease in Adults

In September 2024, a "Prospective, Single-Center, Open-Label, Single-Arm, Single-Dose Clinical Study to Assess the Safety, Tolerability, and Efficacy of LY-M003 Injection for the Treatment of Adult Patients with Wilson's Disease" was initiated at the First Affiliated Hospital of Zhejiang University School of Medicine (hereinafter referred to as "Zhejiang Hospital No. 1"), with Professor Yu Chaohui, the leading figure in the Department of Gastroenterology, serving as the principal investigator. LY-M003 Injection is an innovative gene therapy drug developed by Lingyi (Hangzhou) Biotechnology Co., Ltd. (hereinafter referred to as "Lingyi Bio").

Clinical Trial Recruitment 

Dear Subject,

Zhejiang Hospital No. 1 is conducting a "Prospective, Single-Center, Open-Label, Single-Arm, Single-Dose Clinical Study to Assess the Safety, Tolerability, and Efficacy of LY-M003 Injection for the Treatment of Adult Patients with Wilson's Disease," hereinafter referred to as "this study." This study has been approved by the Ethics Committee of Zhejiang Hospital No. 1 and plans to recruit approximately 5-10 adult patients with Wilson's disease at the Zhejiang Hospital No. 1.

If you or someone you know meets the following criteria, please contact us:

  1. Age ≥18 years and ≤60 years, with no gender restrictions.

  2. The subject fully understands the purpose, nature, and methods of the study, as well as possible adverse reactions, and volunteers as a subject, signing the Informed Consent Form voluntarily.

  3. Patients diagnosed with Wilson's Disease: Assessed with a Leipzig scoring system of ≥4 points.

  4. WD patients confirmed by laboratory testing to have double chromosomal mutations in the ATP7B gene.

  5. Subjects are either newly diagnosed with WD or have been treated for WD with standard therapy (such as D-penicillamine or zinc acetate) for at least 6 months prior to the screening period.

  6. Subjects have been restricting high-copper foods for at least 6 months prior to the screening period and agree to continue doing so during the study.

Your participation is entirely voluntary. If you are interested in participating, please contact the study physician, who will provide you with a detailed introduction to this study and the matters you need to cooperate with, and will preliminarily judge whether you meet the inclusion criteria. Even if you choose not to participate in this study, you will not be subject to any adverse effects, and your information will be kept confidential. Whether you can successfully participate in this study ultimately depends on the investigator's judgment. Your participation will contribute to the advancement of medical science, and we look forward to your involvement.

If you participate in this study, you will receive free drug treatment and related free examinations, as well as certain transportation and nutritional subsidies.

Contact: Clinical Coordinator

Contact Number: 19121572057

 

 

Zhejiang Hospital No. 1's Department of Gastroenterology is not only the earliest established and largest clinical treatment center for digestive system diseases in Zhejiang Province, but also, with its outstanding professional level and academic status, it has become a national clinical key specialty, a national training base for digestive endoscopy diagnosis and treatment technology, a key medical discipline in Zhejiang Province, and the leading unit in the field of digestive system disease research in Zhejiang Province.

 

Professor Yu Chaohui currently serves as the Vice President of Zhejiang Hospital No. 1, and the leader of the Department of Gastroenterology. He is a Professor of Internal Medicine, Chief Physician, and Doctoral Supervisor at Zhejiang University. He has been selected for the National Ten Thousand Talents Program for Science and Technology Innovation Leaders, the Ministry of Science and Technology's Young and Middle-aged Science and Technology Innovation Leaders, and the Ministry of Education's New Century Excellent Talents. He has been successively selected for the second level, first level, and key support of Zhejiang Province's 151 Talent Program, and is a high-level innovative talent in the health sector of Zhejiang Province. Professor Yu has long been engaged in the diagnosis and treatment of digestive system diseases, clinical teaching, and scientific research, focusing on the mechanism research and new drug development for metabolic liver diseases. He has presided over numerous national scientific research projects, including the National Key R&D Program, the National Natural Science Foundation, and sub-topics of the 973 Program.