Ainos submits clinical hold complete response on Phase II trial of VELDONA

Ainos has submitted the clinical hold complete response to the U.S. Food and Drug Administration for conducting a Phase II trial of its low-dose oral interferon-alpha formulation, VELDONA, for treatment of mild COVID-19 symptoms. If approved, the Company’s Phase II trial is expected to involve a multicenter, parallel, randomized study conducted in Taiwan to evaluate the efficacy of VELDONA in subjects with mild COVID-19 symptoms during the third quarter of 2024. Ainos’ recently-commenced VELDONA manufacturing process fully complies with both Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice and the U.S. FDA’s Current Good Manufacturing Practice regulations. The updated Chemistry, Manufacturing, and Controls information indicates that the stability of VELDONA can exceed the minimum shelf life of biologicals. Ainos intends to submit a number of additional IND applications during the second half of 2024, including Phase II/III studies for treatment of oral warts in HIV-seropositive patients, and Phase II/III studies for Sjogren’s syndrome.