Ainos Secures TFDA Approval and IRB Clearance to Advance VELDONA Clinical Trials for HIV Oral Warts and Sjögren's Syndrome in Taiwan

Associated Press

14-04-2025

Dual Trials Accelerate VELDONA® Toward Rare Disease Market Entry
Bridging Strategy Aims to Fast-Track U.S. Regulatory Approvals
SAN DIEGO, CALIFORNIA / ACCESS Newswire / April 14, 2025 / Ainos, Inc. (Nasdaq:AIMD, AIMDW) ('Ainos' or the 'Company'), pioneer of low-dose oral interferon therapeutics, today announced significant progress in advancing its oral interferon drug platform, VELDONA® in the rare disease space. The Taiwan Food and Drug Administration (TFDA) has approved the Company's clinical trial for human immunodeficiency virus (HIV)-related oral warts, while Institutional Review Board (IRB) clearance has been granted for its upcoming Sjögren's Syndrome (pSS) study. The upcoming Taiwan trials will be conducted using the Company's next-generation VELDONA® formulation, aiming to confirm efficacy equal to or better than previous results, as well as accelerating US and Taiwan regulatory approval and commercialization.
'The upcoming Taiwan trials using our new formulation aim to confirm efficacy equal to or better than previous results. We are also pursuing bridging consultations with both Food and Drug Administration (FDA) and TFDA. If regulators confirm alignment, we could accelerate market entry through a harmonized approval process. Our partnership with Taiwan Tanabe Seiyaku for manufacturing and market development of our pSS program further strengthens our commercialization pathway,' said Chun-Hsien (Eddy) Tsai, Chairman, President, and CEO of Ainos.
'Ainos is steadily advancing across three core growth pillars: scent digitization with AI Nose technology, AI-powered point-of-care testing powered by AI Nose, and VELDONA®. These strategic pillars form a foundation to our growth. We're executing rapidly and building momentum across the VELDONA® platform. Our ability to launch two Taiwan trials in parallel reflects our dedication to capital efficiency, operational strength and delivering innovative, patient-friendly therapies to the market,' Mr. Tsai added.
'HIV-related oral warts and primary Sjögren's Syndrome both lack effective standard treatments and impose meaningful burdens on quality of life. As an oral therapy, VELDONA® provides a convenient, non-invasive alternative to injectable interferons-especially important for chronic or immune-compromised patients. We believe our previous Phase II and III trials delivered positive results, and we see significant potential for VELDONA® in these indications,' said Dr. Albert Yu, Technical Director of Pharmaceuticals at Ainos.
These studies expand Ainos' immunotherapy footprint in underserved rare disease segments, in line with the Company's previously announced development plans.
TFDA Approves HIV Oral Warts Trial; Enrollment to Begin in June
Ainos' planned trial, titled 'Evaluation of Human Interferon Alpha Administered Oromucosally in the Treatment of Oral Warts in HIV-Seropositive Subjects Receiving Combination Anti-Retroviral Therapy' (Protocol ID: 03HUHI19), will be conducted at National Taiwan University Hospital (NTUH).
Oral warts are a frequent and painful complication in HIV-positive patients. According to UNAIDS, approximately 39.9 million people globally live with HIV in 2023, with 1.3 million new infections and 630,000 AIDS-related deaths reported that year. Despite prevalence, oral wart treatment remains a poorly addressed niche with limited therapeutic options.
The market for managing HIV-related HPV manifestations, including oral warts, is estimated at $500-700 million globally, driven by demand for safer and more tolerable long-term treatments1.
Ainos plans to begin the trial in June 2025 and targets completion in 2H 2026. Primary and secondary endpoints will evaluate the efficacy of VELDONA® plus antiretroviral therapy compared to placebo. Bestat Pharmaservices Corporation, a TFDA-accredited contract research organization (CRO), will manage the study under Good Clinical Practice (GCP) standards.
IRB Clears Sjögren's Syndrome Trial; TFDA Review in Progress
The planned trial, titled 'An Open-Label Study to Evaluate the Efficacy Of VELDONA® in Patients with Primary Sjögren's Syndrome' (Protocol ID: 24PSS01) received IRB approval from Taipei Medical University - Joint IRB on October 25, 2024 (Approval No.: TMU-JIRB N202408042). TFDA submission is underway, with clearance expected in August 2025.
Sjögren's Syndrome is a chronic autoimmune disease affecting salivary and tear glands, with limited treatment options. According to National Center for Biotechnology Information (NCBI), the condition affects an estimated 400,000 to 3.1 million people in the U.S. alone, mostly women aged 45-55. The global market for Sjögren's Syndrome therapeutics is projected to reach about $3.3 billion by 2030, driven by rising prevalence and increasing demand for effective therapies2.
The trial will take place at Shuang Ho Hospital and evaluate whether VELDONA® improves salivary flow and alleviates dryness symptoms. Secondary endpoints include ESSPRI/ESSDAI scores, symptom-specific VAS ratings, and salivary gland imaging. Ainos aims to initiate site initiation visit (SIV) and first patient first visit (FPFV) in October 2025 and targets to conclude the trial in 1H 2027. ComboTrial Consultancy Ltd, a TFDA-recognized CRO, will manage the trial.
Ainos has previously completed three U.S. clinical trials evaluating VELDONA® in pSS. Results showed significant improvement in oral dryness with a favorable safety profile.
VELDONA®: Transforming Immunotherapy Through Oral Delivery
Harnessing nearly four decades of development, VELDONA® is Ainos' proprietary low-dose oral interferon-alpha platform, designed to activate immune responses via oromucosal delivery. The platform delivers therapeutic benefit at ultra-low doses, minimizing systemic side effects often associated with injectable interferons.
By targeting rare and underserved indications, Ainos is positioning VELDONA® as a versatile, scalable solution for chronic autoimmune and infectious diseases across global markets.
[1]: Market scope estimate based on various analysis of HPV/HIV co-infection treatment segments.
[2]: Market Report Analytics, 'Sjogrens Syndrome Therapeutics Market CAGR Growth Drivers and Trends: Forecasts 2025-2033.'
About Ainos, Inc.
Headquartered in San Diego, California, Ainos, Inc. develops disruptive medical and healthcare solutions based on its proprietary AI Nose and VELDONA® technologies. The name 'Ainos' combines 'AI' and 'Nose' to signify Ainos' commitment to enabling AI with the ability to smell and individuals to live healthier. Ainos' clinical-stage product pipeline includes AI-driven, telehealth-friendly POCT solutions powered by AI Nose, VELDONA® human and animal oral therapeutics, and human orphan drugs. For more information, visit: www.ainos.com. Follow Ainos on X, formerly known as Twitter, ( @AinosInc ) and LinkedIn to stay up-to-date.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management's current assumptions and expectations of future events and trends, which affect or may affect the Company's business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated by the forward-looking statements in this press release. These factors include, among other things, our expectation that we will incur net losses for the foreseeable future; our ability to become profitable; our ability to raise additional capital to continue our product development; our ability to accurately predict our future operating results; our ability to advance our current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates we develop; the ability to obtain and maintain regulatory approval of our product candidates; delays in completing the development and commercialization of our current and future product candidates; developing and commercializing additional products, including diagnostic testing devices; our ability to compete in the marketplace; compliance with applicable laws, regulations and tariffs, and factors described in the Risk Factors section of our public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information, future events and developments or otherwise.
Contact Information
Feifei Shen
[email protected]
SOURCE: Ainos, Inc.
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