Ainos plans to initiate Taiwan clinical study of VELDONA for Sjogren’s Syndrome

Ainos plans to conduct a Taiwan clinical study for very low-dose interferon alpha on treating Sjogren’s syndrome at Taipei Medical University-Shuang Ho Hospital. A total of eight clinical trials have been conducted in the U.S. by the Company to evaluate the use of VELDONA for treating Sjogren’s syndrome. Three Prior Phase 3 studies show positive benefits in increasing unstimulated whole saliva secretion without significant adverse effects. The upcoming study will be conducted by the Allergy, Immunology, and Rheumatology Department at Shuang Ho Hospital. The trial will follow the diagnostic criteria established by the American College of Rheumatology and the European League Against Rheumatism in 2016, aiming to recruit 24 patients. Each participant will take three sublingual tablets of VELDONA daily for 24 to 48 weeks. The primary objective is to evaluate the efficacy of VELDONA in improving saliva secretion and dryness symptoms in patients with primary Sjogren’s syndrome. Secondary objectives include: 1. Measuring the change in the EULAR Sjogren’s Syndrome Patient Reported Index for dryness symptoms on a scale from 0 to 10; 2. Evaluating changes in the EULAR Sjogren’s Syndrome Disease Activity Index; 3. Assessing improvements in oral and ocular symptoms using a visual analog scale for eight dryness-related items; 4. Monitoring salivary gland function using a nuclear medicine salivary gland scan. Study Timeline and Progress ComboTrial Consultancy Ltd., a contract research organization certified by the Taiwan Food and Drug Administration, will manage the clinical trial. Institutional Review Board submission has been completed at Shuang Ho Hospital. TFDA approval is expected to be submitted in October, 2024. The trial is anticipated to complete all regulatory approvals by November 2024, with a site initiation meeting and first patient visit projected for December 2024. The patient enrollment will last approximately six months, with the last patient’s first visit expected by May 2025, and the last patient’s last visit by November 2025. The study is expected to conclude in January 2026.