Ainos announces positive data reported for VELDONA as potential treatment of oral warts in HIV-positive patients

Data partially fulfills the safety and efficacy hypotheses of one pilot and two Phase II clinical studies

Ainos aims to pursue a pre-IND meeting with the U.S. FDA ahead of a planned Phase III study

SAN DIEGO, CA, November 21, 2023 / Ainos, Inc. (NASDAQ:AIMD, AIMDW) (“Ainos”, or the “Company”), a diversified healthcare company focused on the development of AI-powered point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced that positive top-line data has been reported from three clinical studies for its VELDONA® low-dose oral interferon formulation as a potential treatment for oral warts in HIV-seropositive patients. The positive results partially fulfill the hypotheses of the three studies in establishing a safe daily dose, and demonstrate the formulation’s superior efficacy compared to a placebo in relieving oral warts in HIV-seropositive individuals. Based on these results, Ainos plans to pursue a pre-IND meeting with the United States Food and Drug Administration (the “U.S. FDA”) in advance of planned Phase III clinical studies for the drug candidate.

A total of 77 HIV-seropositive subjects were enrolled and evaluated between a pilot study and two Phase II clinical studies. Subjects were randomly assigned to either active treatment or placebo groups, with subjects in the active treatment groups received VELDONA® lozenges via the oral cavity three times per day for 24 weeks. The placebo subjects were given a matching placebo lozenge at the same interval. After a 24-week treatment, subjects who were administered VELDONA® lozenges experienced a reduction of over 75% in the total mucosal surface area covered by oral warts. This was in a significantly greater proportion of HIV-seropositive subjects who are infected with multiple oral warts and who are receiving combination anti-retroviral therapy.

Mr. Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and Chief Executive Officer of Ainos, commented, “Based on the data we have so far, we are excited about the potential for VELDONA® to improve the quality of life of many people living with HIV. Oral warts can significantly reduce a person’s quality of life, causing discomfort during routine activities such as eating and talking, and affecting a person’s appearance. We are optimistic that VELDONA® will serve as a valuable new option for HIV-seropositive individuals seeking relief from oral warts.”

Ainos has conducted three trial studies for the treatment of oral warts in HIV-seropositive patients. The first was an open-label pilot study involving 15 HIV-seropositive males with multiple oral warts. The second was a single-blind, dose-ranging study involving 21 HIV-seropositive subjects with multiple oral warts who received a combination anti-retroviral therapy with or without PI. The third was a double-blind, placebo-controlled trial involving a total of 80 HIV-seropositive participants on highly active antiretroviral therapy (“HAART”), randomized to IFN-alpha (n=60) or placebo (n=20) for up to 24 weeks.

Human immunodeficiency virus, more commonly known as HIV, is a disease which destroys the body’s CD4 cells, which are crucial to immune function. It can increase a patient’s susceptibility to opportunistic infections such as human papillomavirus (“HPV”), tuberculosis, and fungal and bacterial infections. HPV infection has been identified as the most significant risk factor in the development of oral lesions among the HIV-seropositive population. Viral lesions on the mouth of HIV patients are common and may be indicative of disease progression.

Current treatment options for HIV-related oral warts are limited. Pharmacological treatment of intraoral and labial warts is not well-established, with no clinical trials specifically targeting this indication. Only a handful of case reports exist involving the use of drugs such as cidofovir, bleomycin, cimetidine, podophyllum, or intralesional interferon-alpha injections. Oral warts can be surgically removed if they interfere with eating and speaking, or if they are cosmetically displeasing, though surgical removal comes with a risk of local recurrence. The location of the warts and the amount of tissue remaining after removal must also be considered when debating surgical resection.

“I believe there is a tremendous unmet need to improve the quality of life of people living with HIV,” added Mr. Tsai. “Of the estimated 1.2 million HIV-seropositive people in the United States, about 24,000 of them suffer from HIV-related oral warts, representing approximately 2% of the HIV-seropositive population. With oral warts affecting around 1.2 million HIV patients worldwide in 2022, we are hopeful that VELDONA® can one day bring relief to patients who would greatly benefit from better treatment options.”

The U.S. FDA has granted Orphan Drug Designation (“ODD”) for the Company’s VELDONA® low-dose oral interferon formulation as a potential treatment for oral warts in HIV-seropositive patients. Orphan Drug Designation is a special status granted to foster the development and evaluation of new medicines designed to treat, diagnose, or prevent diseases or disorders affecting fewer than 200,000 people in the U.S. ODD status provides benefits including market exclusivity upon regulatory approval, exemption from FDA application fees, and tax credits for qualified clinical trials.

About Ainos, Inc.

Headquartered in San Diego, California, Ainos is a 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”). To learn more, visit https://www.ainos.com.

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