Ainos announces IRB approval for Sjogren’s Syndrome clinical study

Ainos (AIMD) has received Institutional Review Board approval from Shuang Ho Hospital, affiliated with Taipei Medical University, for its clinical trial of VELDONA in treating Sjogren’s syndrome. Ainos plans to commence a site initiation visit for the study around April 2025, subject to regulatory approvals. The study aims to further assess the potential of VELDONA in improving salivary gland function and alleviating symptoms of dryness. Ainos previously conducted eight clinical studies in the U.S., including three Phase 3 trials, showing that VELDONA significantly increases unstimulated whole salivary flow.The study will be conducted at Shuang Ho Hospital under the oversight of the Department of Allergy, Immunology, and Rheumatology. Its primary endpoint is to evaluate the efficacy of VELDONA in improving salivary flow and alleviating dryness symptoms in patients with primary Sjogren’s syndrome. The trial follows an open-label design and will recruit 24 patients for a 24- to 48-week treatment period, based on the diagnostic criteria established by the American and European Rheumatology Associations in 2016. Secondary endpoints include: Assessing improvements in dryness symptoms using the European League Against Rheumatism Sjogren’s Syndrome Patient Reported Index; Measuring changes in disease activity using the EULAR Sjogren’s Syndrome Disease Activity Index; Evaluating eight specific dryness symptoms, including oral and ocular dryness, using the Visual Analog Scale; Conducting nuclear medicine imaging to compare pre- and post-treatment salivary gland function. The trial is managed by ComboTrial Consultancy Ltd. under Good Clinical Practice standards. Following the IRB approval from Shuang Ho Hospital, Ainos plans to submit to Taiwan’s Food and Drug Administration by the end of December 2024 and anticipates to complete all approvals by Q1 2025, with the SIV scheduling for April 2025. Patient recruitment will span six months, with the First Patient First Visit anticipated for May 2025, the Last Patient Last Visit by the end of November 2025, and study completion by the end of December 2026.