Ainos Announces Interim Results of VELDONA Clinical Trial

Ainos 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 , 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. The interim analysis includes the first six treated subjects. Enrollment remains ongoing. The primary disease activity assessment utilized the Stomatitis Disease Activity Index, 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 greater than or equal to30% clinically meaningful improvement. Wilcoxon signed-rank testing demonstrated statistical significance. 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. Comparative hematology and serum biochemistry analyses between baseline and Week 6 demonstrated: Liver enzymes remained within normal limits. Renal function markers 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.