Ainos, Inc. (NASDAQ: AIMD, AIMDW) (“Ainos”, or the “Firm”), a diversified healthcare firm centered on the event of AI-powered point-of-care testing, low-dose interferon therapeutics, and artificial RNA-driven preventative medication, at this time introduced that it had signed a Memorandum of Understanding (“MoU”) with SIDSCO Biomedical Co., Ltd. (“SIDSCO”).
The MoU is a vital step in Ainos’ technique to broaden its product line into the worldwide pet care market. Underneath the settlement, Ainos and SIDSCO (collectively, the “Events”) will collectively discover the feasibility of VELDONA�/Cytoprotein contract medical trials. Ainos intends to conduct animal medical trials for veterinary investigational medicines at the side of SIDSCO, and can present the technical data, funding, and help required for the undertaking.
Ainos’ low-dose oral interferon alpha (“IFNα”) formulation, VELDONA�, is a human interferon first accepted on the market by the Texas Division of Well being in 1985 for the therapy of cats with feline leukemia and canine with canine parvovirus. In 28 earlier research carried out by Ainos, VELDONA� was discovered to exhibit systemic results in mice, cats, canine, ferrets, chickens, rats, guinea pigs, horses, calves/cows, and notably pigs. VELDONA� has aided in boosting feed conversion effectivity and combating lethal viral infections in these species, together with canine parvovirus, equine herpesvirus, feline coronavirus, and others. These research exhibit that VELDONA� has a therapeutic or preventive impact through the oral mucosa. On the identical time, VELDONA� modulates systemic and mucosal immunity with out critical unwanted effects.
Earlier research have confirmed that feline interferon administered to the native oral mucosa can enhance the medical signs of ache in cats and the diploma of irritation within the affected space, and no critical antagonistic drug reactions occurred through the trial interval. The expertise of many veterinarians utilizing over-the-counter medicines has additionally proven that many circumstances of feline persistent gingivostomatitis (FCGS) have been considerably improved by using interferons. It may be seen that interferon has a very good impact on persistent gingivostomatitis in cats, and it has no antagonistic results when utilized in mixture with different medicine. The outcomes of the Agricultural Science and Expertise Analysis Institute’s efficiency and cytotoxicity assessments on VELDONA� utilizing feline macrophages (fcwf-4) confirmed its antiviral efficacy and established an efficient and protected dosage. Ainos’ upcoming medical trial, anticipated to be held in cooperation with SIDSCO at Mercy Animal Medical Middle, will examine VELDONA�’s protected use and efficacy for the therapy of FCGS in cats through oral mucosal administration.
FCGS is characterised by extreme irritation of the gingiva, buccal mucosa, and caudal oral mucosa. There are two sorts of FCGS. Sort 1 contains circumstances with alveolar and labial/buccal mucositis/stomatitis solely, whereas Sort 2 covers circumstances with caudal mucositis/stomatitis, with or with out alveolar and labial/buccal mucositis/stomatitis. The precise reason for FCGS remains to be unknown. Plainly cats with FCGS have a hyperimmune response to plaque, micro organism, viruses, or environmental elements which ends up in extreme irritation. FCGS is a standard situation, with a reported prevalence starting from 0.7% to 12.0%.
Probably the most favorable medical management for decision of oral irritation is through partial or full mouth full tooth extractions. Dental extractions have been proven to treatment FCGS in 55% of circumstances, markedly enhance signs in 35% of circumstances, and haven’t any impact in 10% of circumstances. Refractory FCGS requires lifelong medicine, together with immunosuppressants akin to corticosteroids or cyclosporine, or immunomodulators akin to Feline Interferon Omega. Nevertheless, as a result of potential deleterious side-effects of long-term corticosteroid administration, these ought to solely be used as wanted for symptomatic alleviation through the acute part.
At present, medical administration of FCGS stays extremely variable and infrequently depends upon comorbidities in every particular person case. Usually, present medical therapies for FCGS embody antibiotics, antihistamines, and immunosuppressants, akin to corticosteroids or cyclosporine, which are sometimes first-line remedies for affected animals. Nevertheless, these immunosuppressants have critical long-term unwanted effects, together with sort 2 diabetes and opportunistic infections. At present, there aren’t any medicines for animals that don’t reply to anti-inflammatory or immunosuppressive remedies, and there aren’t any superb long-term options accessible to pet homeowners.
A report compiled by Grand View Analysis exhibits that the worldwide pet dental well being market is projected to develop at a CAGR of 6.2%, reaching US$9.98 billion by 2030. The canine market section accounted for the most important income share at over 55.0%, and the feline market section is anticipated to broaden at a CAGR of 6.9%.
Cat possession in the USA is estimated at 85.5 million, suggesting that as many as 10.3 million cats have FCGS. Companion animal possession continues to rise in the USA, particularly amongst younger folks. About 35% of American households personal a cat. Along with Taiwan, Ainos is actively working to benefit from bigger market alternatives with gross sales in Asia and the USA.
Ainos’ upcoming medical trial is anticipated to be despatched to the USA’ Inside Animal Care and Use Committee (IACUC) for evaluate in December this yr. The medical trial is a small-scale area pre-trial. It’s anticipated to begin accepting circumstances within the first quarter of subsequent yr, and to finish admission of 15-30 cats within the second quarter. If the outcomes of this trial meet the anticipated efficacy necessities, the Firm will submit a proper utility to Taiwan’s Bureau of Prevention and Inspection of the Ministry of Agriculture for animal new drug area trials. This could signify a big step ahead within the strategy of acquiring an animal new drug license. Ainos plans to conduct the upcoming medical research in cooperation with SIDSCO at Mercy Animal Medical Middle.
Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and Chief Govt Officer of Ainos, commented, “We’re thrilled to be taking this important step within the additional development of VELDONA� throughout the pet well being house. The worldwide pet care market is huge, estimated at $223 billion in 2021, making this the right time for us to broaden our VELDONA� portfolio to incorporate a possible therapy possibility for one of the widespread illnesses amongst home cats. By signing this MoU with SIDSCO, we’re intent on accelerating the drug growth course of, and we consider our collaboration will convey substantial advantages to each events. We stay steadfast in our dedication to offering pet homeowners with protected and efficient options to safeguard their animals’ well being, and I sit up for our staff working side-by-side with SIDSCO to make this purpose a actuality.”