Ainos to initiate Taiwan clinical study for VELDONA in oral warts

Ainos announced that its plans to initiate a clinical study for very low-dose interferon alpha on treating Human immunodeficiency virus -related oral warts at the National Taiwan University Hospital. The study aims to evaluate the efficacy of VELDONA, a low-dose oral interferon-alpha formulation, in treating oral warts in HIV-positive patients undergoing combination antiretroviral therapy. VELDONA has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for this indication, offering new hope to HIV-positive individuals suffering from oral warts. This clinical study will be conducted by the Infectious Disease Department at National Taiwan University Hospital, one of Taiwan’s 25 designated medical centers for HIV management. The hospital oversees nearly 4,000 HIV-positive patients, approximately 11.2% of Taiwan’s total HIV cases. The study will enroll 40 participants who will be randomized in a 1:3 ratio to receive either a placebo or VELDONA in a double-blind trial. Participants will take VELDONA or a placebo sublingually every day for 24 weeks. The primary objective of the study is to evaluate the reduction in oral warts’ surface area. A successful response is defined as a reduction of 75% or more in the surface area of oral warts compared to baseline, while a non-responsive result indicates less than 75% reduction. The secondary objectives include evaluating oral wart surface area reduction by 50% or more, as well as participant self-assessments through questionnaires comparing oral health to baseline conditions. The study’s Principal Investigator will also objectively assess the participants’ oral conditions. This clinical study will be conducted in accordance with Good Clinical Practice guidelines by Bestat Pharmaservices Corporation, a TFDA-certified Contract Research Organization. The study is expected to begin in November 2024, with the first patient visit anticipated in November. Patient enrollment is projected to take one year, with the last patient visit expected in May 2026, and study completion anticipated in July 2026. Protocol of the study is currently being reviewed for Investigational Review Board approval by National Taiwan University Hospital and Taiwan Food and Drug Administration. Ainos has conducted one pilot study and two phase 2 trials in the U.S. involving 77 HIV-positive patients with multiple oral warts. In these trials, patients were randomized to receive either VELDONA or a placebo, taking the medication three times daily for 24 weeks. After treatment, patients receiving VELDONA showed significant reductions in oral wart surface area, with decreases of over 75%, and in some cases up to 99%.