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Ainos Enrolls First Topic for Medical Research of VELDONA-Primarily based Animal FCGS Drug By Investing.com

The medical examine of recent potential VELDONA-based animal drug is poised to increase VELDONA’s market.

This medical trial goals to finish the enrollment of 30 topics by the end-2024 with the trial report back to be finalized in Q1 2025.

SAN DIEGO, CA / ACCESSWIRE / July 23, 2024 / Ainos, Inc. (NASDAQ:AIMD, AIMDW) (“Ainos”, or the “Company”), a diversified healthcare firm centered on novel AI-powered point-of-care testing (“POCT”) and low-dose interferon therapeutics (“VELDONA”), at the moment introduced it has enrolled the primary topic for its Taiwanese medical examine of VELDONA ®-based animal drug in treating feline continual gingivostomatitis (“FCGS”), a severe and painful continual cat oral illness characterised by irritation or irregular proliferation within the oral cavity. Dosing of the primary topic is anticipated to happen on July 26, 2024.

This animal medical examine is a randomized, double-blind, parallel, single-center, multiple-dose oral drug trial designed to judge the security, tolerability, and efficacy of low-dose oral interferons within the remedy of FCGS. The medical website in Taiwan is anticipated to enroll 30 topics.

This examine builds on the animal well being analysis of Ainos’ VELDONA ®, a low-dose oral interferon alpha (“IFNα”) formulation that was initially authorised by the Texas Division of Well being in 1985 for treating feline leukemia in cats and canine parvovirus in canines. The trial goals to finish the enrollment of 30 topics by the top of 2024 and to finalize the trial report within the first quarter of 2025. If the outcomes meet expectations, Ainos will provoke the subsequent part involving an utility to a medical discipline trial for an animal drug certificates from the Animal and Plant Well being Inspection Company below Taiwan’s Ministry of Agriculture.

Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and CEO of Ainos, commented, “We are pleased to announce the enrollment of the first subject in the clinical trial, with dosing scheduled for July 26, 2024, marking an important milestone in the animal drug development process of VELDONA ®. Initiating this clinical trial emphasizes our relentless efforts to advance innovative treatment options for cats with FCGS. Furthermore, we are also committed to fully leveraging our VELDONA ® platform to develop a diversified portfolio of products for various therapeutic areas.”

Based on the 2023-2024 American Pet Merchandise Affiliation (APPA) Nationwide Pet House owners Survey, roughly 46.5 million U.S. households have pet cats. With a median of 1.78 cats per family, this ends in a complete of 82.8 million home cats. Given the prevalence fee of 0.7-10%, it’s estimated that as much as 8.3 million cats within the U.S. undergo from FCGS.

Based on the 2023-2024 American Pet Merchandise Affiliation (APPA) Nationwide Pet House owners Survey, roughly 46.5 million U.S. households have pet cats. With a median of 1.78 cats per family, this ends in a complete of 82.8 million home cats. Given the prevalence fee of 0.7-10%, it’s estimated that between 5.8 to eight.3 million cats within the U.S. undergo from FCGS.

Based on Grand View Analysis, the worldwide marketplace for pet dental well being is projected to develop at a compound annual development fee of 6.25% from 2023 to achieve US$9.98 billion in 2030, pushed by components together with rising prevalence of pet dental ailments and rising consciousness for stopping painful dental circumstances in pets.

About VELDONA ® Pet

Primarily based on Ainos’ low-dose oral interferon-alpha (“IFNα”) formulation, VELDONA ® Pet are supported by a number of analysis research and medical trials and are manufactured with world-class supplies in a extremely licensed plant. VELDONA ® Pet goals to keep up immunity in cats and canines by contributing to gum and pores and skin well being for allergy aid and stress discount. Interferon is a substance naturally produced by an organism’s physique. When cells are invaded by overseas particles, immune signaling molecules notify neighboring cells. As soon as neighboring cells obtain the interferon’s protein sign by their floor receptors, they provoke and modulate the immune system to guard felines and canines from gum and pores and skin ailments, allergic reactions, and stress-related circumstances.

An earlier medical examine sponsored by Ainos and carried out by the Agricultural Expertise Analysis Institute in Taiwan has demonstrated that VELDONA ® Pet helps preserve the immune programs of cats and canines. VELDONA ® Pet not solely goals to offer safety towards widespread and hard-to-diagnose ailments together with FCGS, a extreme oral mucosal inflammatory illness afflicting cats, and canine atopic dermatitis (CAD), an inflammatory pores and skin illness present in canines, but in addition goals to supply secure and prime quality merchandise available on the market.

About FCGS

FCGS is characterised by extreme irritation of the gingiva, buccal mucosa, and caudal oral mucosa. There are two kinds of FCGS. Sort 1 consists of instances with alveolar and labial/buccal mucositis/stomatitis solely, whereas Sort 2 covers caudal mucositis/stomatitis, with or with out alveolar and labial/buccal mucositis/stomatitis. As of now, the precise causes of FCGS stays unknown. Cats with FCGS seemingly have a hyperimmune response to plaque, micro organism, viruses, or environmental components to result in extreme irritation. FCGS is a typical situation in cats, with a reported prevalence starting from 0.7% to 12.0%.

At present, medical administration of FCGS stays extremely variable and sometimes is dependent upon comorbidities in every particular person case. Typically, current medical therapies for FCGS embody antibiotics, antihistamines, and immunosuppressants, comparable to corticosteroids or cyclosporine, which are sometimes first-line therapies for affected animals. Nonetheless, these immunosuppressants have severe long-term negative effects, together with kind 2 diabetes and opportunistic infections. At present, no drugs exist for animals which are unresponsive to anti-inflammatory or immunosuppressive therapies, and there are not any preferrred long-term options out there for pet homeowners.

About Ainos, Inc.

Headquartered in San Diego, California, Ainos is a diversified healthcare firm centered on novel AI-powered point-of-care testing (POCT) and VELDONA low-dose interferon therapeutics. The Firm’s clinical-stage product pipeline consists of VELDONA human and animal oral therapeutics, human orphan medication, and telehealth-friendly POCT options powered by its AI Nostril expertise platform.

The title “Ainos” is a mix of “AI” and “Nose” to replicate the Firm’s dedication to empowering people to handle their well being extra successfully with next-generation AI-driven POCT options. To be taught extra, go to https://www.ainos.com.

Observe Ainos on X, previously often called Twitter, (@AinosInc) and LinkedIn to remain up-to-date.

Secure Harbor Assertion

Sure statements on this press launch are forward-looking statements inside the which means of Part 27A of the Securities Act of 1933, as amended, and Part 21E of the Securities Alternate Act of 1934, as amended. All statements apart from statements of historic reality are forward-looking statements. Ahead-looking statements may be recognized by way of phrases comparable to “anticipate,” “believe,” “estimate,” “approximate,” “expect,” “intend,” “plan,” “predict,” “project,” “target,” “future,” “likely,” “strategy,” “foresee,” “may,” “guidance,” “potential,” “outlook,” “forecast,” “should,” “will” or different comparable phrases or phrases. Equally, statements that describe the Firm’s goals, plans or targets are, or could also be, forward-looking statements. Ahead-looking statements are based mostly solely on the Firm’s present beliefs, expectations, and assumptions. Ahead-looking statements are topic to inherent uncertainties, dangers, and modifications in circumstances which are troublesome to foretell and plenty of of that are outdoors of the Firm’s management. The Firm’s precise outcomes might differ materially from these indicated within the forward-looking statements.

Essential components that would trigger the Firm’s precise outcomes to vary materially from the projections, forecasts, estimates and expectations mentioned on this press launch embody, amongst others, the price of manufacturing and gross sales potential of the merchandise introduced on this press launch; the Firm’s dependence on projected revenues from the sale of present or future merchandise ; the Firm’s restricted money and historical past of losses; the Firm’s potential to realize profitability; the Firm’s potential to lift further capital to proceed the Firm’s product growth; the power to precisely predict the longer term working outcomes of the Firm; the power to advance Ainos’ present or future product candidates by medical trials, receive advertising and marketing approval and finally commercialize any product candidates the Firm develops; the power to acquire and preserve regulatory approval of Ainos’ product candidates; delays in finishing the event and commercialization of the Firm’s present and future product candidates, which may end in elevated prices to the Firm, delay or restrict the power to generate income and adversely have an effect on the enterprise, monetary situation, outcomes of operations and prospects of the Firm; intense competitors and quickly advancing expertise within the Firm’s business that will outpace its expertise; buyer demand for the services the Firm develops; the accuracy of third-party market analysis knowledge, the influence of aggressive or different merchandise, applied sciences and pricing; disruption in analysis and growth amenities; lawsuits and different claims by third events or investigations by numerous regulatory businesses governing the Firm’s operations; potential cybersecurity assaults; elevated necessities and prices associated to cybersecurity; the Firm’s potential to appreciate the advantages of third occasion licensing agreements; the Firm’s potential to acquire and preserve mental property safety for Ainos product candidates; compliance with relevant legal guidelines, laws and tariffs; continued itemizing on and compliance with the relevant laws of the Nasdaq Capital Market; and the Firm’s success in managing development. A extra full description of those danger components and others is included within the “Risk Factors” part of Ainos’ Annual Report on Type 10-Ok for the 12 months ended December 31, 2023, and different public filings with the U.S. Securities and Alternate Fee (“SEC”), a lot of which dangers are past the Firm’s management. Along with the dangers described above and within the Firm’s filings with the SEC, different unknown or unpredictable components additionally may trigger precise outcomes to vary materially from the projections, forecasts, estimates and expectations mentioned on this press launch.

The forward-looking statements made on this press launch are expressly certified of their entirety by the foregoing cautionary statements. Any forward-looking statements contained on this press launch characterize Ainos’ views solely as of at the moment and shouldn’t be relied upon as representing its views as of any subsequent date. Ainos undertakes no obligation to, and expressly disclaims any such obligation to, publicly replace or revise any forward-looking assertion to replicate modified assumptions, the incidence of anticipated or unanticipated occasions or modifications to the longer term outcomes over time or in any other case, besides as required by legislation.

Investor Relations Contact

Feifei Shen
E mail: IR@ainos.com

SOURCE: Ainos, Inc.

View the unique press launch on accesswire.com

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