Ainos Receives TFDA Approval to Initiate Clinical Study of VELDONA for Primary Sjögren's Syndrome
Rhea-AI Summary
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.
Positive
- 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
Negative
- 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
News Market Reaction – AIMD
On the day this news was published, AIMD gained 0.41%, reflecting a mild positive market reaction. Argus tracked a peak move of +19.1% during that session. Argus tracked a trough of -14.4% from its starting point during tracking. Our momentum scanner triggered 18 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $42K to the company's valuation, bringing the market cap to $10M at that time. Trading volume was exceptionally heavy at 12.7x the daily average, suggesting very strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
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
What is the significance of TFDA approval for Ainos (AIMD) VELDONA clinical study?
How many patients were involved in VELDONA's previous clinical trials?
When will Ainos (AIMD) complete the VELDONA clinical study in Taiwan?
What is the market potential for VELDONA in treating primary Sjögren's syndrome?
What were the results of VELDONA's previous clinical trials?
