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 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 innovative medical technologies for point-of-care testing and safe and novel medical treatment for a broad range of disease indications. In addition to its proprietary therapeutics using low-dose non-injectable interferon, Ainos is committed to developing a comprehensive healthcare business portfolio encompassing medical devices and consumer healthcare products. While prioritizing the commercialization of medical devices as part of its diversification strategy, Ainos has also expanded its product portfolio to include Volatile Organic Compounds (VOC) and COVID-19 POCTs. Leveraging its patents related to VOC technologies and COVID-19 POCT products, the Company seeks to expedite the commercialization of its medical device pipeline, beginning with Ainos-branded COVID-19 POCT product candidates. More information about the Company may be found at www.ainos.com.
This press release contains 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict," "project," 'target," "future," "seek," "likely," "strategy," "may," "should," "will," and similar references to future periods. Forward-looking statements are based only on our current beliefs, expectations, and assumptions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements.
Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others, the following: the cost of production and sales potential of the planned drug treatments announced in this press release; the impact of final approvals from the U.S. Food and Drug Administration (the "FDA") or other regulatory bodies for the planned drug treatments including the availability of emergency use authorization; the Company's limited cash and history of losses; the Company's ability to achieve profitability; intense competition and rapidly advancing technology in the Company's industry that may outpace its technology; customer demand for the products and services the Company develops; the impact of competitive or alternative products, technologies and pricing; the Company's ability to manufacture any products it develops; general economic conditions and events and the impact they may have on the Company and its potential customers, including but not limited to the impact of Covid-19; the Company's ability to obtain adequate financing in the future; the impact of promulgation and implementation of regulations by the World Health Organization, the FDA and by other governmental authorities with functions similar to those of the FDA on the Company's operations and technologies; lawsuits and other claims by third parties or investigations by various regulatory agencies governing the Company's operations; the Company's ability to secure regulatory approvals for its products; and our success in managing the risks involved in the foregoing items. Readers should also review the risks and uncertainties listed in our Annual Report on Form 10-K for the year ended December 31, 2021 and other reports we file with the U.S. Securities and Exchange Commission.
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SOURCE: Ainos, Inc.
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