Ainos receives TFDA approval to initiate clinical study of VELDONA

Ainos (AIMD) announced that its investigational low-dose oral interferon-alpha drug candidate, VELDONA, has received formal approval from Taiwan’s Food and Drug Administration to initiate a clinical study for primary Sjogren’s syndrome. The open-label study, titled “An open-label study to evaluate the efficacy of VELDONA in patients with primary Sjogren’s Syndrome”, 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 Sjogren’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.