Boston, MA, September 19th, 2023 - The U.S. Food and Drug Administration (FDA) has granted Ainos' VELDONA Orphan Drug Designation (ODD) for the treatment of oral warts in HIV-seropositive patients. VELDONA is Very Low-Dose Oral Interferon Alpha, Ainos' proprietary oral lozenge formulation of Interferon alpha (IFN-α) that has been extensively tested in preclinical and 68 human clinical studies, including three Phase 1, 63 Phase 2, and three Phase 3 studies, several which have been conducted in the U.S.
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- An estimated 24,000 HIV-seropositive Americans suffer from chronic oral warts.
- Orphan Drug Designation fosters the development of new medicines to treat or prevent rare diseases and disorders, as well as provides tax credits, reduced FDA application fees, and guaranteed market exclusivity upon approval.
- Ainos plans to seek a pre-IND meeting with the U.S. FDA, with plans to advance VELDONA into a Phase 3 study for oral warts. We estimate in excess of a $1 Billion global market opportunity for the company.
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About Ainos, Inc.
Ainos Inc. (AIMD) is a NASDAQ-listed diversified healthcare company focused on the development of novel point-of-care testing ("POCT"), low-dose VELDONA interferon therapeutics, and synthetic RNA-driven preventative medicine. The company's products include VELDONA clinical-stage human therapeutics, VELDONA Pet cytoprotein health supplements, and telehealth-friendly POCTs powered by its AI Nose technology platform. The lead POCT candidate, Ainos Flora, is intended to be a telehealth-friendly POCT for women's health and certain common sexually transmitted infections ("STIs").
The company is headquartered in San Diego, CA, and has substantial operations in Taiwan. As of December 31, 2022, Ainos had 43 full-time employees, 27 dedicated to R&D, primarily located in Taiwan. Ainos has constructed its infrastructure to be capital-efficient by choosing Taiwan as the R&D and operating center. Taiwan is a key global technology supply chain center home to many high-caliber engineers, scientists, and healthcare professionals. Maintaining operations in Taiwan allows Ainos to access top-quality talent while staying capital-efficient, further enhancing the company's ability to offer quality, affordable, consumer-friendly products.In total, the company owns 63 patents, of which 50 are active patents, and 13 are pending patent approval.
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Source: Horizon Insights
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