Ainos Reports Breakthrough Interim Results in VELDONA Clinical Trial for FCGS, Signaling New Era in Companion Animal Immunotherapy

Rhea-AI Summary

Ainos (NASDAQ: AIMD) has reported promising interim results from its veterinary clinical trial of VELDONA, a low-dose interferon therapy for Feline Chronic Gingivostomatitis (FCGS). The trial, involving 30 cats, shows significant improvements in treating chronic inflammation. Key findings from the first three completed cases include inflammation score reductions ranging from 10.5% to 44.4%, with successful reduction or elimination of steroid dependency. The therapy demonstrated strong tolerability with no significant side effects. This breakthrough positions Ainos to tap into the global pet dental market, projected to reach $13 billion by 2030. The results suggest VELDONA could revolutionize companion animal immunotherapy by offering a steroid-free treatment option for chronic inflammatory conditions.

Positive

• Successful interim results showing inflammation score improvements of up to 44.4% in treated cats
• Achievement of steroid-free remission in multiple cases with no relapses
• No significant side effects observed in any treated cases
• Targeting a large addressable market worth $13 billion by 2030
• Potential first-mover advantage in animal interferon therapy

Negative

• Small sample size with only 3 completed cases out of planned 30
• Varying efficacy rates across cases (10.5% to 44.4% improvement)
• One case showed limited improvement (10.5%) compared to others

Insights

Veterinary Medicine Specialist

Ainos' VELDONA shows promising early results treating feline oral inflammation, with steroid-reduction benefits in a small sample.

The interim results from Ainos' veterinary trial of VELDONA for Feline Chronic Gingivostomatitis (FCGS) present encouraging but preliminary evidence of efficacy. With only three completed cases and one in progress from a planned 30-cat trial, these results must be viewed as highly preliminary.

The data shows inflammation score improvements ranging from 10.5% to 44.4% across the three completed cases, with the most notable benefit being the steroid-sparing effect. In veterinary medicine, reducing or eliminating steroid dependency represents a significant clinical advancement, as long-term steroid use carries substantial side effects including diabetes, immunosuppression, and liver complications.

The case highlighting a cat that failed to respond to a high-dose injectable interferon but showed improvement with VELDONA is particularly interesting, suggesting a potential mechanism advantage for low-dose oral delivery. FCGS is notoriously difficult to treat, with current options limited to steroids, antibiotics, and often tooth extraction as a last resort.

However, several critical questions remain unanswered: the durability of response, whether inflammation scores correlate with clinical improvement in eating and comfort, and most importantly, how VELDONA compares to standard care in a properly powered study. The small sample size and lack of control group data in this interim report make definitive conclusions impossible.

The $13 billion market projection seems to encompass the entire pet dental market rather than the specific FCGS indication, which represents a much smaller subset. While chronic oral inflammation in cats is common, affecting approximately 0.7% to 10% of cats depending on the population studied, translating this early signal into market capture requires substantial additional evidence and regulatory approval pathways.

Biotechnology Analyst

From a biotech perspective, what makes the VELDONA results notable is the novel application of low-dose oral interferon in veterinary medicine. Interferons are powerful immunomodulatory proteins typically administered at high doses parenterally, often with significant side effects. The oral low-dose approach represents a mechanistically distinct strategy that could potentially offer better tolerability.

The case comparison with the French high-dose injectable interferon suggests Ainos may have identified an important therapeutic window where lower doses provide efficacy while avoiding toxicity. This parallels human immunotherapy development where finding the optimal biological dose rather than maximum tolerated dose has become increasingly important.

The steroid-sparing effect observed across all three completed cases is particularly significant as a surrogate endpoint. In immunological conditions, steroid independence while maintaining disease control is considered a high-value outcome that correlates with improved long-term health.

However, the technology still faces substantial challenges before commercialization. The trial's limited size (targeting 30 cats total) suggests this is primarily a proof-of-concept study rather than a pivotal trial. The company will likely need to conduct larger controlled studies before regulatory submission. Additionally, while the press release mentions high and low dose groups, no comparative data between these groups is provided, leaving questions about dose optimization.

Unlike many biotechs that focus exclusively on human therapeutics, Ainos appears to be pursuing a veterinary-first strategy with VELDONA. This approach could potentially provide faster revenue generation and proof-of-mechanism with less regulatory burden than human trials, potentially supporting their broader platform development. The global companion animal health market continues to grow rapidly, with increasing willingness to pay for advanced therapeutics in pets, particularly in conditions with limited treatment options.

Early results show steroid-free remission, opening pathway into $13B global pet dental health market

VELDONA delivers consistent anti-inflammatory effects, strengthening Ainos' positioning in companion animal immunotherapy

SAN DIEGO, CALIFORNIA / ACCESS Newswire / May 19, 2025 / Ainos, Inc. (Nasdaq:AIMD)(Nasdaq:AIMDW) ("Ainos"), a pioneer of low-dose oral interferon therapeutics, today announced compelling interim results from its ongoing veterinary clinical trial using low-dose interferon VELDONA for treating Feline Chronic Gingivostomatitis ("FCGS"), a chronic inflammatory conditions in cats. The interim results demonstrate meaningful improvements in inflammation and a consistent reduction in steroid dependency, indicating strong commercial and scientific potential for a novel class of immunotherapy in companion animals.

The randomized, controlled trial aims to enroll 30 cats, divided into high- and low-dose treatment groups, to assess pre- and post-treatment inflammation scores, corticosteroid usage, and safety. The focus is on chronic inflammatory diseases such as feline gingivostomatitis-an area where effective long-term treatments remain limited and largely reliant on steroids.

To date, three cats have completed treatment, with a fourth currently in progress. All cases have shown clear clinical improvements and strong tolerability:

• Case 1 (5-year-old cat, severe oral inflammation):

  • Inflammation score reduced from 19 to 17 (10.5% improvement)

  • Previous treatment with a French high-dose injectable interferon treatment was ineffective

  • Steroid dose successfully reduced from 0.8mg/kg/day to 0.5mg/kg/day with stable condition

• Case 2 (14-year-old cat, chronic inflammation):

  • Score reduced from 16 to 12.3 (23.1% improvement)

  • Steroid therapy was fully discontinued two months after treatment; condition remains stable

• Case 3 (index case):

  • Score reduced from 9 to 5 (44.4% improvement)

  • Steroids discontinued post-treatment; no relapse observed

No significant side effects were observed in any case. The results also suggest a steroid-sparing effect, which is critical for improving long-term outcomes in aging or chronically ill pets.

Dr. Albert Yu, Technical Director of Pharmaceuticals at Ainos, commented: "We are witnessing a potential paradigm shift in treating chronic inflammatory diseases in companion animals. Our interferon therapy not only shows efficacy in reducing inflammation but also opens the door to steroid-free or steroid-reduced treatment strategies, which could significantly elevate animal welfare worldwide."

A High-Growth Market with Global Opportunity

According to Global Market Insights, the global pet dental market is projected to reach nearly $13 billion by 2030, driven by increasing focus on preventive care and growing awareness about pet dental health. By leveraging its proprietary interferon technology, Ainos is positioning itself at the forefront of this expanding market-potentially establishing a first-mover advantage in animal interferon therapy.

We believe these early clinical signals reinforce Ainos' leadership in translational biotech and help lay the foundation for future commercial strategies, including partnerships, licensing, and regulatory engagements across major veterinary markets.

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 the Company's commitment to enabling AI with the ability to smell and individuals to live healthier. The Company's 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. 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 are the interim results of Ainos (AIMD) VELDONA clinical trial for FCGS?

The interim results show inflammation score reductions of 10.5% to 44.4% in three completed cases, with successful reduction or elimination of steroid dependency and no significant side effects.

How large is the market opportunity for Ainos (AIMD) VELDONA therapy?

The global pet dental market is projected to reach $13 billion by 2030, representing a significant opportunity for Ainos' VELDONA therapy.

What is the success rate of steroid reduction in Ainos (AIMD) VELDONA trial?

Two out of three treated cats achieved complete steroid discontinuation, while one case reduced steroid dosage from 0.8mg/kg/day to 0.5mg/kg/day with stable condition.

How many cats are enrolled in the Ainos (AIMD) VELDONA clinical trial?

The trial aims to enroll 30 cats divided into high- and low-dose treatment groups, with 3 cases completed and a fourth in progress as of May 2025.

What are the safety results of Ainos (AIMD) VELDONA treatment?

No significant side effects were observed in any of the treated cases, demonstrating strong tolerability of the therapy.