Ainos, Inc. announced it has received Institutional Review Board (IRB) approval from Shuang Ho Hospital, affiliated with Taipei Medical University. This approval is for conducting a clinical study of VELDONA for primary Sjögren's syndrome. The IRB Approval No. is TMU-JIRB No. 202409009.
This milestone keeps the IRB approval on track as scheduled, moving the VELDONA program forward in its clinical development. The next step involves obtaining all necessary regulatory approvals from the Taiwan Food and Drug Administration, followed by a site initiation visit. This sequential progress is crucial for advancing the trial.
Previous Phase 3 studies have indicated that VELDONA significantly increases unstimulated salivary flow, suggesting its potential as a treatment for this autoimmune disease. This regulatory step is vital for validating VELDONA's efficacy and safety, bringing it closer to potential commercialization for patients with limited treatment options.
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