Ainos receives IRB approval from National Taiwan University Hospital

Ainos has received Institutional Review Board approval from the National Taiwan University Hospital for its clinical trial focused on treating oral warts in HIV-positive patients. This trial will evaluate VELDONA, Ainos’ low-dose oral interferon formulation, which has received orphan drug designation from the U.S. Food and Drug Administration, as a potential treatment for HIV-related oral warts. The clinical trial, titled “Evaluation of Human Interferon Alpha Administered Oromucosally in the Treatment of Oral Warts in HIV-Seropositive Subjects Receiving Combination Anti-Retroviral Therapy”, will be conducted as a single-site study at the National Taiwan University Hospital. The trial was submitted for IRB review on June 27, 2024, and received formal approval on September 18, 2024. The study will enroll 40 HIV-positive participants, who will be randomly assigned in a 1:3 ratio to either the VELDONA group or a placebo group. Participants will take 10 sublingual tablets of VELDONA or placebo daily for 24 weeks. The primary and secondary endpoints of the trial are to evaluate the efficacy of VELDONA in combination with antiretroviral therapy compared to placebo in treating oral warts in HIV-positive patients. Before the trial can officially begin, an approval from Taiwan Food and Drug Administration is required. Ainos has already submitted the application through Bestat Pharmaservices Corporation, a TFDA-certified Contract Research Organization, on August 28, 2024. The Site Initiation Visit is expected to take place in November 2024, with patient enrollment anticipated to last one year. The study is expected to conclude by July 2026.