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Ainos Submits Investigational New Drug Application to the U.S. FDA to Conduct Phase 2 Trial of its VELDONA Low-dose Oral Interferon Formulation Against Mild COVID-19 Symptoms
SAN DIEGO, CA / ACCESSWIRE / August 24, 2022 / Ainos, Inc. (NASDAQ:AIMD, AIMDW) ("Ainos", or the "Company"), a diversified medtech company focused on the
About this update from Ainos, Inc.
[{"type":"text","content":"SAN DIEGO, CA / ACCESSWIRE / August 24, 2022 / Ainos, Inc. (NASDAQ:AIMD, AIMDW) (\"Ainos\", or the \"Company\"), a diversified medtech company focused on the development of novel point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for conducting a Phase 2 trial of its low-dose oral interferon (IFN)-alpha formulation, VELDONA®, for treatment of mild symptoms related to COVID-19.If approved, the Company's Phase 2 trial is expected to involve a multicenter, parallel, randomized study conducted in Taiwan to evaluate the efficacy of VELDONA® in subjects with mild symptoms related to COVID-19. As currently planned, human subjects will receive either a daily oral dose of VELDONA® or a standard of care (SoC) for 5 days and will be evaluated throughout a 28-day study period.Type I IFN, which has demonstrated immunomodulating effects and an ability to interfere with viral replication, may be an effective antiviral agent. \"Patients with severe and critical COVID-19 conditions, seem to be affected by an impairment in type I IFN response (no IFN-beta and low IFN-alpha production and activity). Our Company is investigating whether impaired type I IFN could be related to persistent high blood viral loads and inflammatory responses in COVID-19 cases.\" stated Chun-Hsien Tsai, the Company's Chairman of the Board, President and CEO.Ainos has developed its low-dose oral IFN-alpha formulation VELDONA® to boost the human immune response against disease and infection. The Company's previous studies have demonstrated that VELDONA could inhibit respiratory virus infection, including influenza A.\"We continue to build on our prior studies on influenza, the common cold and flu. Given our promising results with VELDONA® to date, we are optimistic that it may become a potential treatment for mild COVID-19 symptoms in the future. We also look forward to expanding our VELDONA® platform for treatment of other viral infections, as a component of our long-term strategy to enhance and realize the value of this unique compound.\" stated Ainos' CEO Chun-Hsien Tsai.About Ainos, Inc.Headquartered in San Diego, California, Ainos, Inc. is a diversified medtech company engaged in developing innovat...