Ainos, Inc. (NASDAQ:AIMD) is collaborating with Taiwan Tanabe Seiyaku to advance the manufacturing and commercialization of VELDONA®, a low-dose interferon alpha formulation, for the treatment of Sjögren's syndrome in Taiwan. This partnership aims to expedite the availability of this potential therapy to patients.
Clinical Trial Approved to Evaluate VELDONA®
Ainos has received Institutional Review Board (IRB) approval from Shuang Ho Hospital, affiliated with Taipei Medical University, to conduct a clinical trial of VELDONA® in Sjögren's syndrome. The study, managed by ComboTrial Consultancy Ltd. under Good Clinical Practice (GCP) standards, is set to begin a site initiation visit around April 2025, pending regulatory approvals. Patient recruitment is scheduled to commence in May 2025, with study completion anticipated by the end of December 2026.
Study Design and Objectives
The open-label trial will enroll 24 patients diagnosed with primary Sjögren's syndrome, based on the American and European Rheumatology Associations' 2016 diagnostic criteria. Participants will receive three sublingual tablets of low-dose interferon alpha daily for 24 to 48 weeks. The primary endpoint is to evaluate VELDONA®'s efficacy 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 using the Visual Analog Scale (VAS), and conducting nuclear medicine imaging to compare pre- and post-treatment salivary gland function.
Prior Clinical Data
Ainos previously conducted three clinical trials in the U.S. evaluating VELDONA® for Sjögren's syndrome. Results from these trials suggest that VELDONA® has the potential to significantly improve oral dryness symptoms without serious adverse reactions. One double-blind, placebo-controlled study (n=241) showed a statistically significant increase in unstimulated whole salivary flow (p<0.05) in patients receiving VELDONA®. A subsequent study (n=256) indicated a trend toward increased unstimulated whole salivary flow (p<0.10), although this did not reach statistical significance. An open-label safety study (n=288) reported significant improvements in oral dryness and comfort (p<0.0001) and in all eight symptom scores (p<0.05) with no treatment-related serious adverse reactions.
Sjögren's Syndrome: An Overview
Sjögren's syndrome is an autoimmune disease affecting an estimated 400,000 to 3.1 million adults in the U.S., with an average onset age of 45 to 55 years. The disease primarily affects middle-aged women, with a female-to-male ratio of 9:1. It is characterized by the immune system mistakenly attacking its own tissues, leading to dryness of the eyes and mouth. The global market for treating Sjögren's syndrome is expected to grow at a compound annual growth rate (CAGR) of 4.2% through 2030.
Management Commentary
"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," said Dr. Albert Yu, Technical Director of Pharmaceuticals at Ainos.
