Ainos Secures TFDA Approval and IRB Clearance to Advance VELDONA Clinical Trials for HIV Oral Warts and Sjögren's Syndrome in Taiwan
Ainos (NASDAQ:AIMD) has achieved significant milestones in advancing its VELDONA® oral interferon drug platform. The company secured TFDA approval for HIV-related oral warts clinical trial and IRB clearance for Sjögren's Syndrome study in Taiwan.
The HIV oral warts trial (Protocol ID: 03HUHI19) will commence in June 2025 at National Taiwan University Hospital, targeting completion in 2H 2026. The global market for HIV-related HPV manifestations is estimated at $500-700 million.
The Sjögren's Syndrome trial (Protocol ID: 24PSS01) received IRB approval from Taipei Medical University, with TFDA clearance expected in August 2025. The trial aims to evaluate VELDONA's efficacy in improving salivary flow and alleviating dryness symptoms, targeting completion in 1H 2027. The global Sjögren's Syndrome therapeutics market is projected to reach $3.3 billion by 2030.
Ainos (NASDAQ:AIMD) ha raggiunto traguardi significativi nello sviluppo della sua piattaforma di farmaci per via orale a base di interferone VELDONA®. L'azienda ha ottenuto l'
Il trial sui condilomi orali da HIV (ID Protocollo: 03HUHI19) inizierà a giugno 2025 presso l'Ospedale Universitario Nazionale di Taiwan, con completamento previsto nel secondo semestre del 2026. Il mercato globale per le manifestazioni HPV correlate all'HIV è stimato tra i 500 e i 700 milioni di dollari.
Il trial sulla sindrome di Sjögren (ID Protocollo: 24PSS01) ha ricevuto l'approvazione IRB dall'Università Medica di Taipei, con l'approvazione TFDA attesa per agosto 2025. Lo studio mira a valutare l'efficacia di VELDONA nel migliorare il flusso salivare e alleviare i sintomi di secchezza, con completamento previsto nel primo semestre del 2027. Si prevede che il mercato globale dei farmaci per la sindrome di Sjögren raggiunga i 3,3 miliardi di dollari entro il 2030.
Ainos (NASDAQ:AIMD) ha logrado hitos significativos en el avance de su plataforma de medicamentos orales de interferón VELDONA®. La compañía obtuvo la aprobación de la TFDA para un ensayo clínico sobre verrugas orales relacionadas con el VIH y la autorización del IRB para un estudio sobre el síndrome de Sjögren en Taiwán.
El ensayo sobre verrugas orales del VIH (ID de protocolo: 03HUHI19) comenzará en junio de 2025 en el Hospital Universitario Nacional de Taiwán, con un objetivo de finalización en el segundo semestre de 2026. Se estima que el mercado global para manifestaciones de HPV relacionadas con el VIH es de entre 500 y 700 millones de dólares.
El ensayo sobre el síndrome de Sjögren (ID de protocolo: 24PSS01) recibió la aprobación del IRB de la Universidad Médica de Taipéi, con la autorización de la TFDA esperada para agosto de 2025. El ensayo tiene como objetivo evaluar la eficacia de VELDONA en la mejora del flujo salival y la reducción de los síntomas de sequedad, con un objetivo de finalización en el primer semestre de 2027. Se proyecta que el mercado global de terapias para el síndrome de Sjögren alcance los 3.3 mil millones de dólares para 2030.
Ainos (NASDAQ:AIMD)는 구강 인터페론 약물 플랫폼 VELDONA®의 발전에서 중요한 이정표를 달성했습니다. 이 회사는 HIV 관련 구강 사마귀에 대한 임상 시험에 대해 TFDA 승인을 받았고, 대만에서의 쇼그렌 증후군 연구에 대해 IRB 승인을 받았습니다.
HIV 구강 사마귀 시험(프로토콜 ID: 03HUHI19)은 2025년 6월 대만 국립대학교 병원에서 시작되며, 2026년 하반기 완료를 목표로 하고 있습니다. HIV 관련 HPV 발현의 글로벌 시장은 5억에서 7억 달러로 추정됩니다.
쇼그렌 증후군 시험(프로토콜 ID: 24PSS01)은 타이베이 의과대학에서 IRB 승인을 받았으며, TFDA 승인은 2025년 8월에 예상됩니다. 이 시험은 VELDONA의 타액 흐름 개선 및 건조 증상 완화 효능을 평가하는 것을 목표로 하며, 2027년 상반기 완료를 목표로 하고 있습니다. 글로벌 쇼그렌 증후군 치료제 시장은 2030년까지 33억 달러에 이를 것으로 예상됩니다.
Ainos (NASDAQ:AIMD) a atteint des jalons significatifs dans l'avancement de sa plateforme de médicaments oraux à base d'interféron VELDONA®. L'entreprise a obtenu l'
L'essai sur les verrues orales liées au VIH (ID de protocole : 03HUHI19) commencera en juin 2025 à l'Hôpital Universitaire National de Taïwan, avec un achèvement prévu au deuxième semestre 2026. Le marché mondial des manifestations HPV liées au VIH est estimé entre 500 et 700 millions de dollars.
L'essai sur le syndrome de Sjögren (ID de protocole : 24PSS01) a reçu l'approbation de l'IRB de l'Université Médicale de Taipei, avec l'approbation de la TFDA attendue pour août 2025. L'essai vise à évaluer l'efficacité de VELDONA dans l'amélioration du flux salivaire et l'atténuation des symptômes de sécheresse, avec un achèvement prévu au premier semestre 2027. Le marché mondial des thérapeutiques pour le syndrome de Sjögren devrait atteindre 3,3 milliards de dollars d'ici 2030.
Ainos (NASDAQ:AIMD) hat bedeutende Meilensteine bei der Weiterentwicklung seiner oralen Interferon-Arzneimittelplattform VELDONA® erreicht. Das Unternehmen erhielt die TFDA-Zulassung für eine klinische Studie zu HIV-bedingten oralen Warzen sowie die IRB-Freigabe für eine Studie zum Sjögren-Syndrom in Taiwan.
Die klinische Studie zu HIV-oralen Warzen (Protokoll-ID: 03HUHI19) beginnt im Juni 2025 am National Taiwan University Hospital, mit dem Ziel, im zweiten Halbjahr 2026 abgeschlossen zu sein. Der globale Markt für HIV-bezogene HPV-Manifestationen wird auf 500 bis 700 Millionen Dollar geschätzt.
Die Studie zum Sjögren-Syndrom (Protokoll-ID: 24PSS01) erhielt die IRB-Zulassung von der Taipei Medical University, während die TFDA-Zulassung für August 2025 erwartet wird. Die Studie zielt darauf ab, die Wirksamkeit von VELDONA bei der Verbesserung des Speichelflusses und der Linderung von Trockenheitssymptomen zu bewerten, mit dem Ziel, im ersten Halbjahr 2027 abgeschlossen zu sein. Der globale Markt für Therapeutika bei Sjögren-Syndrom wird bis 2030 voraussichtlich 3,3 Milliarden Dollar erreichen.
- Received TFDA approval for HIV oral warts clinical trial
- Secured IRB clearance for Sjögren's Syndrome study
- Partnership with Taiwan Tanabe Seiyaku for manufacturing and market development
- Previous Phase II and III trials for Sjögren's Syndrome showed significant improvement
- Targeting substantial market opportunities: $500-700M for HIV-related HPV and $3.3B for Sjögren's Syndrome by 2030
- Long timeline to market - HIV trial completion in 2H 2026
- Sjögren's Syndrome trial completion not expected until 1H 2027
- TFDA clearance for Sjögren's trial still pending
- Requires additional regulatory approvals for US market entry
Insights
Ainos's dual regulatory clearances for VELDONA® clinical trials mark tangible progress in its rare disease commercialization strategy. The TFDA approval for the HIV-related oral warts trial and IRB clearance for Sjögren's Syndrome studies unlock paths to two substantial markets - estimated at $500-700M and $3.3B respectively by 2030.
The company's bridging strategy with US/Taiwan regulators is particularly noteworthy. If successful, this approach could significantly accelerate time-to-market through harmonized approval processes, potentially reducing redundant clinical work and cutting years from traditional development timelines.
VELDONA®'s oral delivery mechanism addresses a critical patient need, offering a non-invasive alternative to injectable interferons - especially valuable for HIV and autoimmune patients requiring long-term therapy. The technology's previous promising results in Phase II/III trials for Sjögren's Syndrome suggest efficacy potential.
With concrete trial timelines established (HIV warts trial starting June 2025, Sjögren's in October 2025) and partnerships secured (Taiwan Tanabe Seiyaku), Ainos has created a structured pathway to potential commercialization in indications with treatment options and significant unmet need. For a
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
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
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
ir@ainos.com
SOURCE: Ainos, Inc.
View the original press release on ACCESS Newswire
FAQ
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