Ainos Receives TFDA Approval to Initiate Clinical Study of VELDONA for Primary Sjögren's Syndrome
Ainos (NASDAQ:AIMD) has received approval from Taiwan's Food and Drug Administration (TFDA) to initiate a clinical study for its drug candidate VELDONA® in treating primary Sjögren's syndrome (pSS). The open-label study will commence at Taipei Medical University-Shuang Ho Hospital in October 2025, with completion expected in H1 2027.
VELDONA®, a low-dose oral interferon-alpha drug, has previously demonstrated significant efficacy in three large U.S. clinical trials involving 497 patients, with 300 receiving VELDONA® treatment. The drug showed notable improvement in dryness-related symptoms without serious adverse events.
Primary Sjögren's syndrome affects between 400,000 and 3.1 million people globally, with no FDA-approved therapies currently available for this chronic autoimmune disorder.
Ainos (NASDAQ:AIMD) ha ottenuto l'approvazione dalla Food and Drug Administration di Taiwan (TFDA) per avviare uno studio clinico sul suo candidato farmaco VELDONA® nel trattamento della sindrome di Sjögren primaria (pSS). Lo studio open-label inizierà presso il Taipei Medical University-Shuang Ho Hospital nell'ottobre 2025, con completamento previsto nella prima metà del 2027.
VELDONA®, un farmaco orale a basso dosaggio di interferone alfa, ha già dimostrato un'efficacia significativa in tre grandi studi clinici negli Stati Uniti con 497 pazienti, di cui 300 trattati con VELDONA®. Il farmaco ha mostrato un miglioramento notevole nei sintomi legati alla secchezza senza eventi avversi gravi.
La sindrome di Sjögren primaria colpisce tra 400.000 e 3,1 milioni di persone nel mondo, e attualmente non esistono terapie approvate dalla FDA per questo disturbo autoimmune cronico.
Ainos (NASDAQ:AIMD) ha recibido la aprobación de la Administración de Alimentos y Medicamentos de Taiwán (TFDA) para iniciar un estudio clínico con su candidato a medicamento VELDONA® para el tratamiento del síndrome de Sjögren primario (pSS). El estudio abierto comenzará en el Taipei Medical University-Shuang Ho Hospital en octubre de 2025, con finalización prevista para la primera mitad de 2027.
VELDONA®, un medicamento oral de interferón alfa en dosis bajas, ha demostrado previamente una eficacia significativa en tres grandes ensayos clínicos en EE.UU. con 497 pacientes, de los cuales 300 recibieron tratamiento con VELDONA®. El fármaco mostró una notable mejoría en los síntomas relacionados con la sequedad sin eventos adversos graves.
El síndrome de Sjögren primario afecta a entre 400,000 y 3.1 millones de personas en todo el mundo, y actualmente no existen terapias aprobadas por la FDA para este trastorno autoinmune crónico.
Ainos (NASDAQ:AIMD)는 대만 식품의약국(TFDA)으로부터 원발성 쇼그렌 증후군(pSS) 치료를 위한 신약 후보 VELDONA® 임상 시험 시작 승인을 받았습니다. 이 공개 라벨 연구는 2025년 10월 타이페이 의과대학-쌍허 병원에서 시작되며, 2027년 상반기 완료될 예정입니다.
저용량 경구용 인터페론 알파 제제인 VELDONA®는 이전에 미국 내 3건의 대규모 임상 시험에서 497명의 환자 중 300명이 VELDONA® 치료를 받으며 유의미한 효능을 입증했습니다. 이 약물은 심각한 부작용 없이 건조 증상 개선에 뚜렷한 효과를 보였습니다.
원발성 쇼그렌 증후군은 전 세계적으로 40만에서 310만 명 사이가 영향을 받으며, 현재 이 만성 자가면역 질환에 대해 FDA 승인 치료법은 없습니다.
Ainos (NASDAQ:AIMD) a obtenu l'approbation de la Food and Drug Administration de Taïwan (TFDA) pour lancer une étude clinique sur son candidat-médicament VELDONA® dans le traitement du syndrome de Sjögren primaire (pSS). Cette étude ouverte débutera à l'Hôpital Shuang Ho de l'Université Médicale de Taipei en octobre 2025, avec une fin prévue au premier semestre 2027.
VELDONA®, un médicament oral à faible dose d'interféron alpha, a déjà démontré une efficacité significative lors de trois grands essais cliniques aux États-Unis impliquant 497 patients, dont 300 traités par VELDONA®. Le médicament a montré une amélioration notable des symptômes liés à la sécheresse sans événements indésirables graves.
Le syndrome de Sjögren primaire touche entre 400 000 et 3,1 millions de personnes dans le monde, et il n'existe actuellement aucun traitement approuvé par la FDA pour ce trouble auto-immun chronique.
Ainos (NASDAQ:AIMD) hat von der taiwanesischen Lebensmittel- und Arzneimittelbehörde (TFDA) die Genehmigung erhalten, eine klinische Studie für seinen Arzneimittelkandidaten VELDONA® zur Behandlung des primären Sjögren-Syndroms (pSS) zu starten. Die offene Studie beginnt im Oktober 2025 am Taipei Medical University-Shuang Ho Hospital und soll im ersten Halbjahr 2027 abgeschlossen sein.
VELDONA®, ein orales Interferon-Alpha-Medikament in niedriger Dosierung, zeigte bereits in drei großen klinischen Studien in den USA mit 497 Patienten, davon 300 mit VELDONA® behandelt, eine signifikante Wirksamkeit. Das Medikament verbesserte deutlich die trockenen Symptome ohne schwerwiegende Nebenwirkungen.
Das primäre Sjögren-Syndrom betrifft weltweit zwischen 400.000 und 3,1 Millionen Menschen, und es gibt derzeit keine von der FDA zugelassenen Therapien für diese chronische Autoimmunerkrankung.
- Previous clinical trials showed significant improvement in dryness-related symptoms with no serious adverse events
- Large-scale trial data available from 497 patients, demonstrating safety and efficacy
- Addresses an unmet medical need with no current FDA-approved treatments
- Potential market of 400,000 to 3.1 million patients globally
- Study completion not expected until first half of 2027
- Still requires future FDA approval for U.S. market entry
- Limited to Taiwan market for current clinical study
Insights
TFDA approval for VELDONA clinical study represents meaningful progress for Ainos in addressing an underserved autoimmune disease with previous promising safety data.
Ainos has secured a critical regulatory milestone with TFDA approval to initiate a clinical study for VELDONA in primary Sjögren's syndrome (pSS). This open-label study will begin enrollment in October 2025 at Taipei Medical University-Shuang Ho Hospital, with completion expected by mid-2027.
What's particularly noteworthy is VELDONA's established clinical history. The drug has already been evaluated in three large-scale US clinical trials involving 497 pSS patients, with 300 receiving the actual treatment. These previous studies demonstrated significant improvement in dryness-related symptoms with no serious adverse events - a compelling safety profile for chronic use.
This development addresses a substantial unmet medical need. Primary Sjögren's syndrome affects between 400,000 and 3.1 million people globally according to NCBI data, yet has no FDA-approved therapies. The condition causes debilitating symptoms including dry mouth, dry eyes, joint pain, and fatigue.
The company's approach with low-dose oral interferon-alpha represents a potentially differentiated therapeutic strategy in the autoimmune space, where many treatments come with significant side effects. If successful, VELDONA could position Ainos competitively in treating this rare but substantially underserved autoimmune condition while bolstering their dual AI/biotech platform strategy.
Advancing a Novel, Side-Effect-Free Treatment for a Rare Yet Widely Underserved Autoimmune Disease
SAN DIEGO, CALIFORNIA / ACCESS Newswire / August 4, 2025 / Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) ("Ainos" or the "Company"), a Texas incorporated, dual-platform AI and biotech company pioneering smelltech and immune therapeutics, today announced that its investigational low-dose oral interferon-alpha drug candidate, VELDONA®, has received formal approval from Taiwan's Food and Drug Administration (TFDA) to initiate a clinical study for primary Sjögren's syndrome (pSS).
The open-label study, titled "An open-label study to evaluate the efficacy of VELDONA® in patients with primary Sjögren's Syndrome" (Study No. 24PSS01), will be conducted at Taipei Medical University-Shuang Ho Hospital, one of Taiwan's leading academic medical centers. The trial is scheduled to begin patient enrollment in October 2025, with a six-month enrollment period and overall study completion anticipated in the first half of 2027. Clinical operations and monitoring will be managed by ComboTrial Consultancy Ltd, a TFDA-certified and GCP-compliant contract research organization.
VELDONA® has previously been evaluated in three large-scale clinical trials conducted in the United States, enrolling a total of 497 patients diagnosed with primary Sjögren's syndrome:
The first Phase III trial enrolled 241 participants, each receiving 24 weeks of treatment.
The second Phase III trial enrolled 256 participants, also treated for 24 weeks.
A third follow-up study included participants who completed either of the two initial trials and underwent an additional 24 weeks of treatment, contributing to the total enrollment of 497.
Among these, 300 patients were treated with VELDONA®, while the remainder received placebo. The trials demonstrated that VELDONA® significantly improved dryness-related symptoms--such as dry mouth and dry eyes--with no serious adverse events reported, highlighting its potential for long-term, well-tolerated use.
"Our mission is to bring meaningful solutions to people living with chronic, underserved autoimmune conditions," said Eddy Tsai, Chairman and CEO of Ainos. "Primary Sjögren's syndrome has affected millions worldwide and, to our knowledge, currently lacks a safe or effective standard treatment. VELDONA® represents our commitment to delivering a low-side-effect, immune-modulating therapy backed by rigorous science and real-world evidence."
"This TFDA approval validates our continued investment in global clinical development and underscores our belief that VELDONA® can be a transformative solution for patients and healthcare systems alike."
Primary Sjögren's syndrome (pSS) is a chronic autoimmune disorder that primarily affects the salivary and tear glands, causing dryness symptoms, joint pain, and fatigue. Although classified as a rare disease in the United States, a 2022 report by the National Center for Biotechnology Information (NCBI) estimates the global prevalence to be between 400,000 and 3.1 million people, with onset typically occurring between the ages of 45 and 55.
Currently, no therapies have been approved by the U.S. FDA specifically for pSS, representing a significant and globally underserved medical need.
About VELDONA®
VELDONA® is Ainos' proprietary low-dose oral interferon formulation designed to modulate immune response without the adverse effects typically associated with injectable interferon therapies. The platform is being developed for multiple indications across human and veterinary medicine, including viral infections, autoimmune disorders, and chronic inflammatory diseases. Harnessing nearly 40 years of research, VELDONA® has demonstrated a strong safety profile and immunomodulatory potential in clinical and preclinical studies. Ainos is advancing clinical trials in Asia to validate its therapeutic efficacy and unlock global licensing opportunities.
About Ainos, Inc.
Ainos, Inc. (NASDAQ: AIMD) is a dual-platform AI and biotech company pioneering smelltech and immune therapeutics. Its AI Nose platform and smell language model (SLM) digitize scent into Smell ID, a machine-readable data format, powering intelligent sensing across robotics, smart factories, and healthcare. The company also develops VELDONA®, a low-dose oral interferon targeting rare, autoimmune, and infectious diseases. Ainos, a fusion of "AI" and "Nose," is redefining machine perception for the sensory age. To learn more, visit https://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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