Ainos receives Taiwan approval for VELDONA clinical study

Ainos Inc. (NASDAQ: AIMD) announced that Taiwan's Food and Drug Administration approved its application to initiate a clinical study of VELDONA for primary Sjögren's syndrome.

The open-label study will be conducted at Taipei Medical University-Shuang Ho Hospital. Patient enrollment is scheduled to begin in October 2025, with a six-month enrollment period and study completion anticipated in the first half of 2027.

VELDONA is Ainos' investigational low-dose oral interferon-alpha drug candidate. The company previously conducted three clinical trials in the United States, enrolling 497 patients with primary Sjögren's syndrome. Among these participants, 300 received VELDONA treatment while others received placebo across studies lasting 24 weeks each.

According to the company, the trials demonstrated that VELDONA improved dryness-related symptoms such as dry mouth and dry eyes, with no serious adverse events reported.

"Primary Sjögren's syndrome has affected millions worldwide and, to our knowledge, currently lacks a safe or effective standard treatment," said Eddy Tsai, Chairman and CEO of Ainos.

Primary Sjögren's syndrome is a chronic autoimmune disorder affecting salivary and tear glands, causing dryness symptoms, joint pain, and fatigue. A 2022 report by the National Center for Biotechnology Information estimates global prevalence between 400,000 and 3.1 million people, with onset typically occurring between ages 45 and 55.

Currently, no therapies have been approved by the U.S. FDA specifically for primary Sjögren's syndrome.

Clinical operations and monitoring for the Taiwan study will be managed by ComboTrial Consultancy Ltd, described as a TFDA-certified and GCP-compliant contract research organization.

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