Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) has announced that it has received Institutional Review Board (IRB) approval from Shuang Ho Hospital, affiliated with Taipei Medical University, for its clinical trial of VELDONA® in treating Sjögren's syndrome. The study, set to commence around April 2025 pending regulatory approvals, aims to assess VELDONA®'s potential in improving salivary gland function and alleviating dryness symptoms associated with the autoimmune disease.
Clinical Trial Design and Objectives
The open-label study (Protocol Title: An open-label study to evaluate the efficacy of VELDONA® in patients with primary Sjögren's syndrome) will enroll 24 patients with primary Sjögren's syndrome for a 24- to 48-week treatment period, based on the 2016 diagnostic criteria established by the American and European Rheumatology Associations. The primary endpoint is to evaluate the efficacy of VELDONA® in improving salivary flow and alleviating dryness symptoms.
Secondary endpoints include:
- Assessing improvements in dryness symptoms using the European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI).
- Measuring changes in disease activity using the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI).
- Evaluating eight specific dryness symptoms, including oral and ocular dryness, using the Visual Analog Scale (VAS).
- 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 (GCP) standards. Following the IRB approval from Shuang Ho Hospital (TMU-JIRB No.: N202408042), Ainos plans to submit to Taiwan's Food and Drug Administration (TFDA) 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 (FPFV) anticipated for May 2025, the Last Patient Last Visit (LPLV) by the end of November 2025, and study completion by the end of December 2026.
Prior Clinical Data on VELDONA®
Ainos has previously conducted three clinical trials in the U.S. evaluating VELDONA® for Sjögren's syndrome. Results indicate the product has the potential to significantly improve oral dryness symptoms without serious adverse reactions.
In a 24-week double-blind, placebo-controlled study with 241 patients, those receiving 150 IU of HBL IFNα three times daily showed a significant increase in unstimulated whole salivary flow (p<0.05). A similar study with 256 patients indicated a trend toward increased unstimulated whole salivary flow in the 150 IU HBL IFNα treatment group (p<0.10), although this did not reach statistical significance. A 48-week open-label safety study with 288 patients showed significant improvement in oral dryness and comfort (p<0.0001), with significant improvements observed in all eight symptom scores (p<0.05). No treatment-related serious adverse reactions were noted.
Sjögren's Syndrome: Disease Overview
Sjögren's syndrome is an autoimmune disease affecting an estimated 0.1% to 0.4% of the global population. It primarily affects middle-aged women aged 40 to 60, with a female-to-male ratio of 9:1. The disease is characterized by the body attacking its own tissues, leading to symptoms such as dryness of the mouth and eyes. The global market for treating Sjögren's syndrome is expected to grow at a compound annual growth rate (CAGR) of 4.2% through 2030.
"We are thrilled to receive IRB approval of our clinical study in Taiwan as scheduled. Given the previous clinical trials, we are enthusiastic about VELDONA®'s potential to enhance life quality for patients with Sjögren's syndrome. We look forward to positioning VELDONA® as a breakthrough treatment option," commented Dr. Albert Yu, Technical Director of Pharmaceuticals at Ainos.
