Open-Label Study Demonstrates Durable Reduction in Oral Inflammation with Favorable Tolerability Profile at Interim Analysis
HOUSTON, TEXAS / ACCESS Newswire / February 17, 2026 / Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) ("Ainos" or the "Company"), a SmellTech platform company digitizing scent as a native data language for artificial intelligence, today announced interim results from its ongoing open-label, multi-dose clinical trial evaluating VELDONA, a low-dose oral interferon alpha formulation, for the treatment of Feline Chronic Gingivostomatitis (FCGS), a severe, chronic inflammatory oral disease in companion animals.
The study is designed to enroll 12 client-owned cats diagnosed with FCGS across two dosing cohorts (6,000 IU and 12,000 IU administered orally three times per week for six weeks). The interim analysis includes the first six treated subjects. Enrollment remains ongoing.
Interim Efficacy Results
The primary disease activity assessment utilized the Stomatitis Disease Activity Index (SDAI; range 0-30), a composite score integrating:
Veterinary assessment of oral inflammation
Body weight changes
Owner-reported activity and feeding behavior
At Week 6:
The majority of subjects demonstrated reductions in total SDAI scores.
Directional improvement in overall disease activity was observed across the cohort.
No clinically significant rebound was observed through Week 14 follow-up.
Local oral inflammation scores demonstrated consistent and statistically significant improvement:
6 of 6 cats showed lower oral inflammation scores at Week 6 compared to baseline.
Mean improvement reached approximately 38% at Week 6.
66.7% of subjects achieved =30% clinically meaningful improvement.
Wilcoxon signed-rank testing demonstrated statistical significance (p < 0.05).
At Week 14 follow-up, mean improvement in oral inflammation increased to approximately 45%, suggesting sustained benefit after completion of the six-week treatment course.
Notably, one subject that did not undergo full-mouth dental extraction achieved measurable clinical improvement during interferon therapy, supporting a therapeutic effect independent of surgical recovery and consistent with an immunomodulatory mechanism.
Ainos plans to continue enrollment toward the full 12-subject target and further evaluate dose-response relationships, durability of effect, and safety outcomes in the complete dataset.
Safety and Tolerability
Comparative hematology and serum biochemistry analyses between baseline (Week 0) and Week 6 demonstrated:
Liver enzymes (ALP, ALT, AST) remained within normal limits.
Renal function markers (BUN, creatinine) remained stable without dose-related deterioration.
No persistent leukocyte abnormalities or evidence of immunosuppression were observed.
No dose-related toxicity trends were observed.
VELDONA was well tolerated in all six subjects, with no clinically significant safety signals identified in this interim analysis.
Study Overview
Design: Open-label, multi-dose clinical study
Population: Client-owned cats diagnosed with FCGS
Dosing: 6,000 IU (n=4) or 12,000 IU (n=2), administered orally three times weekly for six weeks
Setting: Five subjects underwent full-mouth dental procedures prior to treatment; one subject received dental cleaning only
Clinical and Market Context
FCGS is a debilitating, immune-mediated condition characterized by chronic oral inflammation, pain, and reduced quality of life. Current management often relies on invasive dental extractions and symptomatic therapies, with variable outcomes. An effective, non-invasive immunomodulatory approach could represent a meaningful advancement in companion animal care.
The global pet dental health market size is projected to reach USD 12.70 billion by 2030, growing at a CAGR of 7.57% from 2025 to 2030, according to Grand View Research.
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
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Investor Relations Contact
Feifei Shen
Email: IR@ainos.com
SOURCE: Ainos, Inc.
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https://www.accessnewswire.com/newsroom/en/computers-technology-and-internet/ainos-reports-statistically-significant-interim-efficacy-results-1137503
