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Veldona Animal Study Enrolls First Subject, Marking a Good Start

Enrolled first subject in feline oral disease study, paving way for animal health opportunity. The randomized, double-blind Veldona animal study will enroll 30 cats with feline chronic gingivostomatitis (FCGS) at a single Taiwan clinical site. Two dosage groups, a low dose (6,000 IU) and high dose (12,000 IU), will be evaluated. The first enrolled subject will be dosed later this week. Ainos expects to complete enrollment by year-end, with data in 1Q25. Positive results would support a pivotal field study for animal drug approval in Taiwan, marking a good start in Veldona animal drug development and expanding commercial opportunity beyond human drugs. Preclinical data support Veldona activity in animals. In an in-vitro cell assay study, Veldona showed an EC50 of 1062 U/ml in virally infected feline cells, compared with 38.8 U/ml EC50 for active control (feline IFN). The higher EC50 supports Veldona’s low dose form, which modulates the immune system but with better tolerability and less side effects. FCGS market size expanding, as cat ownership grows. An estimated 46.5 million US households have pet cats, according to the 2023-2024 APPA National Pet Owners Survey. The average number of cats owned per household is approximately 1.78, totaling 82.8 million domestic cats in the US. With a 0.7-10% prevalence rate, an estimated 5.8-8.3 million US cats have FCGS. China had approximately 65.4 million pet cats in 2022, which grew 13% from 2021, a year when cats exceeded the number of pet dogs for the first time in the country. In Taiwan, the number of pet cats totaled 1.3 million in 2023, with ownership growing rapidly, a 50% increase over the prior two years, according to the Ministry of Agriculture. Limited treatment options for cats. FCGS is a chronic oral disease in cats, characterized by severe painful inflammation of the gingiva and oral mucosa. An overstimulated immune response to oral pathogens, like plaque bacteria and feline viruses, is the suspected cause. Current FCGS treatment is to minimize oral bacteria and control inflammation through complete tooth extractions and the use of immunosuppressive drugs, corticosteroids or cyclosporine, in refractory cases. Feline recombinant interferon-omega (FeIFN-?), an immunomodulator and Type 1 interferon, is also an option, but difficult to obtain in the US given a lack of FDA approval. Tooth extractions of partial or full mouth have shown a cure rate of 55%, improvement in 35%, and a 10% failure rate. Less effective first-line treatment options include antibiotics and antihistamines, as well as immunosuppressants. Ideally, corticosteroids and cyclosporine are acute therapies, as long-term chronic use have serious side effects, particularly corticosteroids, which can lead to diabetes mellitus, organ damage, and opportunistic infections.