Ainos, Inc. (Nasdaq: AIMD, AIMDW), a biotechnology company specializing in low-dose oral interferon therapeutics, has announced promising interim results from its ongoing clinical trial of VELDONA for the treatment of Feline Chronic Gingivostomatitis (FCGS), a painful inflammatory condition affecting cats.
The randomized, controlled trial, which aims to enroll 30 cats divided into high and low-dose treatment groups, has already shown meaningful improvements in inflammation scores and reduced steroid dependency in the first three completed cases.
Significant Clinical Improvements Observed
The interim data reveals consistent anti-inflammatory effects across all treated cases:
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A 5-year-old cat with severe oral inflammation showed a 10.5% reduction in inflammation score (from 19 to 17) and was able to reduce steroid dosage from 0.8mg/kg/day to 0.5mg/kg/day while maintaining a stable condition. Notably, this cat had previously failed treatment with a high-dose injectable interferon product.
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A 14-year-old cat with chronic inflammation demonstrated a 23.1% improvement in inflammation score (from 16 to 12.3) and was able to completely discontinue steroid therapy two months after treatment, with the condition remaining stable.
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The index case achieved the most dramatic improvement with a 44.4% reduction in inflammation score (from 9 to 5) and has maintained remission without steroids since completing treatment.
A fourth case is currently undergoing treatment. Importantly, no significant side effects have been observed in any of the treated animals.
Addressing an Unmet Need in Veterinary Medicine
FCGS represents a significant challenge in veterinary medicine, with limited effective long-term treatment options. Current approaches rely heavily on corticosteroids, which can cause serious side effects with prolonged use, especially in aging or chronically ill animals.
Dr. Albert Yu, Technical Director of Pharmaceuticals at Ainos, highlighted the potential paradigm shift this therapy represents: "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."
The steroid-sparing effect demonstrated in these early results is particularly significant, as it could substantially improve long-term outcomes for affected animals by reducing exposure to the adverse effects of chronic steroid use.
Market Potential and Commercial Strategy
The global pet dental market represents a substantial commercial opportunity, projected to reach nearly $13 billion by 2030 according to Global Market Insights. This growth is 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. The company believes these early clinical signals reinforce its leadership in translational biotech and help lay the foundation for future commercial strategies, including partnerships, licensing, and regulatory engagements across major veterinary markets.
Trial Design and Methodology
The ongoing trial is designed to assess pre- and post-treatment inflammation scores, corticosteroid usage, and safety profiles. The focus on chronic inflammatory diseases such as feline gingivostomatitis targets an area where effective long-term treatments remain limited.
The trial's dual-arm design, comparing high and low doses of VELDONA, will provide valuable data on optimal dosing strategies for future development and commercialization efforts.
About VELDONA Technology
VELDONA represents Ainos's proprietary low-dose oral interferon technology. Unlike traditional high-dose injectable interferons, which often cause significant side effects, the low-dose oral approach appears to modulate immune responses more gently while maintaining efficacy.
This approach could potentially be applied to other chronic inflammatory conditions in companion animals, expanding the potential therapeutic applications beyond FCGS.
Company Background
Headquartered in San Diego, California, Ainos develops medical and healthcare solutions based on its proprietary AI Nose and VELDONA technologies. The company's clinical-stage product pipeline includes AI-driven point-of-care testing solutions, VELDONA human and animal oral therapeutics, and human orphan drugs.
The positive interim results from this veterinary trial could have implications for the company's human health programs as well, potentially validating the broader platform technology across species.
