Ainos, Inc. (AIMD, Financial) has made significant headway in the development of its oral interferon drug platform, VELDONA, targeted at rare disease treatments. The Taiwan Food and Drug Administration (TFDA) has greenlit a clinical trial designed to address oral warts in individuals with HIV, and an additional study for Sjogren’s Syndrome has received clearance from the Institutional Review Board (IRB).
The clinical trial focusing on HIV-related oral warts will take place at the National Taiwan University Hospital, utilizing Ainos' innovative VELDONA formulation. This trial, slated to commence in June 2025 with a projected completion by the second half of 2026, aims to verify the drug's efficacy alongside antiretroviral therapy against a placebo. Bestat Pharmaservices Corporation, a TFDA-certified contract research organization, will oversee the study under stringent Good Clinical Practice guidelines.
Furthermore, a separate study evaluating VELDONA for Sjogren’s Syndrome has secured IRB approval from Taipei Medical University – Joint IRB as of October 2024. The company is currently seeking TFDA approval, which it expects to obtain by August 2025. This trial will occur at Shuang Ho Hospital and will assess the improvement in salivary flow and the reduction of dryness symptoms in patients. The trial is expected to begin in October 2025 and conclude by the first half of 2027, with oversight by ComboTrial Consultancy Ltd, another TFDA-accredited organization.
