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Advancing a Novel, Side-Effect-Free Treatment for a Rare Yet Widely Underserved Autoimmune Disease
Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) ("Ainos" or the "Company"), a Texas incorporated, dual-platform AI and biotech company pioneering smelltech and immune therapeutics, today announced that its investigational low-dose oral interferon-alpha drug candidate, VELDONA®, has received formal approval from Taiwan's Food and Drug Administration (TFDA) to initiate a clinical study for primary Sjögren's syndrome (pSS).
The open-label study, titled "An open-label study to evaluate the efficacy of VELDONA® in patients with primary Sjögren's Syndrome" (Study No. 24PSS01), will be conducted at Taipei Medical University-Shuang Ho Hospital, one of Taiwan's leading academic medical centers. The trial is scheduled to begin patient enrollment in October 2025, with a six-month enrollment period and overall study completion anticipated in the first half of 2027. Clinical operations and monitoring will be managed by ComboTrial Consultancy Ltd, a TFDA-certified and GCP-compliant contract research organization.
VELDONA® has previously been evaluated in three large-scale clinical trials conducted in the United States, enrolling a total of 497 patients diagnosed with primary Sjögren's syndrome:
The first Phase III trial enrolled 241 participants, each receiving 24 weeks of treatment.
The second Phase III trial enrolled 256 participants, also treated for 24 weeks.
A third follow-up study included participants who completed either of the two initial trials and underwent an additional 24 weeks of treatment, contributing to the total enrollment of 497.
Among these, 300 patients were treated with VELDONA®, while the remainder received placebo. The trials demonstrated that VELDONA® significantly improved dryness-related symptoms--such as dry mouth and dry eyes--with no serious adverse events reported, highlighting its potential for long-term, well-tolerated use.
"Our mission is to bring meaningful solutions to people living with chronic, underserved autoimmune conditions," said Eddy Tsai, Chairman and CEO of Ainos. "Primary Sjögren's syndrome has affected millions worldwide and, to our knowledge, currently lacks a safe or effective standard treatment. VELDONA® represents our commitment to delivering a low-side-effect, immune-modulating therapy backed by rigorous science and real-world evidence."
