Ainos Enrolls First Subject for Clinical Study of VELDONA-Based Animal FCGS Drug

Rhea-AI Summary

Ainos (NASDAQ:AIMD) has enrolled the first subject for its Taiwanese clinical study of VELDONA®-based animal drug in treating feline chronic gingivostomatitis (FCGS). The study aims to evaluate the safety, tolerability, and efficacy of low-dose oral interferons for FCGS treatment. With 30 subjects expected to be enrolled by end-2024, the trial report is anticipated to be finalized in Q1 2025. This milestone marks a significant step in Ainos' efforts to expand VELDONA's market and develop innovative treatments for cats with FCGS. The potential market is substantial, with an estimated 5.8 to 8.3 million cats in the U.S. affected by FCGS. The global pet dental health market is projected to reach US$9.98 billion by 2030, growing at a CAGR of 6.25% from 2023.

Positive

• Enrollment of first subject in VELDONA-based animal drug clinical trial for FCGS treatment
• Potential to expand VELDONA's market in the animal health sector
• Large potential market with up to 8.3 million cats affected by FCGS in the U.S.
• Global pet dental health market projected to reach US$9.98 billion by 2030

Negative

• Clinical trial results not expected until Q1 2025
• Further regulatory approvals required after trial completion

Insights

Medical Research Analyst

The initiation of clinical trials for Ainos' VELDONA-based drug to treat feline chronic gingivostomatitis (FCGS) is a significant milestone. This disease is a severe inflammatory condition in cats' oral cavities and a successful treatment could address a substantial unmet need. The trial builds on Ainos' previous successes with VELDONA in treating feline leukemia and canine parvovirus, indicating a strong scientific foundation. This trial's double-blind, randomized design ensures robust and reliable data, which is essential for future regulatory approvals. If the trial proves successful, it could pave the way for commercial applications, significantly expanding Ainos' product portfolio in veterinary medicine.

Market Research Analyst

The potential market for a successful FCGS treatment is substantial. According to the American Pet Products Association, up to 8.3 million cats in the U.S. alone suffer from this condition. With the global pet dental health market projected to reach nearly $10 billion by 2030, driven by increasing pet ownership and awareness of pet health, Ainos stands to gain significantly if it can capture even a small portion of this market. The company's strategic focus on leveraging its existing VELDONA platform to diversify into new therapeutic areas positions it well for long-term growth. Investors should monitor the trial's progress closely, as positive results could lead to significant revenue opportunities.

Financial Analyst

From a financial perspective, the initiation of this clinical trial marks a noteworthy development for Ainos. The company's ability to secure approval for VELDONA in past applications indicates a track record of regulatory success, which bodes well for this new trial. The commitment to complete enrollment by end-2024 and finalize reports by Q1 2025 sets a clear timeline for investors to watch. Given the promising market potential, this trial could enhance Ainos' valuation, particularly if it leads to a commercial product. However, investors should remain cautious and consider the inherent risks associated with clinical trials, including the possibility of unmet endpoints and subsequent delays or additional costs.

The clinical study of new potential VELDONA-based animal drug is poised to expand VELDONA's market.

This clinical trial aims to complete the enrollment of 30 subjects by the end-2024 with the trial report 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 company focused on novel AI-powered point-of-care testing ("POCT") and low-dose interferon therapeutics ("VELDONA"), today announced it has enrolled the first subject for its Taiwanese clinical study of VELDONA®-based animal drug in treating feline chronic gingivostomatitis ("FCGS"), a serious and painful chronic cat oral disease characterized by inflammation or abnormal proliferation in the oral cavity. Dosing of the first subject is expected to occur on July 26, 2024.

This animal clinical study is a randomized, double-blind, parallel, single-center, multiple-dose oral drug trial designed to evaluate the safety, tolerability, and efficacy of low-dose oral interferons in the treatment of FCGS. The clinical site in Taiwan is expected to enroll 30 subjects.

This study builds on the animal health research of Ainos' VELDONA®, a low-dose oral interferon alpha ("IFNα") formulation that was initially approved by the Texas Department of Health in 1985 for treating feline leukemia in cats and canine parvovirus in dogs. The trial aims to complete the enrollment of 30 subjects by the end of 2024 and to finalize the trial report in the first quarter of 2025. If the results meet expectations, Ainos will initiate the next phase involving an application to a clinical field trial for an animal drug certificate from the Animal and Plant Health Inspection Agency under 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."

According to the 2023-2024 American Pet Products Association (APPA) National Pet Owners Survey, approximately 46.5 million U.S. households have pet cats. With an average of 1.78 cats per household, this results in a total of 82.8 million domestic cats. Given the prevalence rate of 0.7-10%, it is estimated that up to 8.3 million cats in the U.S. suffer from FCGS.

According to the 2023-2024 American Pet Products Association (APPA) National Pet Owners Survey, approximately 46.5 million U.S. households have pet cats. With an average of 1.78 cats per household, this results in a total of 82.8 million domestic cats. Given the prevalence rate of 0.7-10%, it is estimated that between 5.8 to 8.3 million cats in the U.S. suffer from FCGS.

According to Grand View Research, the global market for pet dental health is projected to grow at a compound annual growth rate of 6.25% from 2023 to reach US$9.98 billion in 2030, driven by factors including increasing prevalence of pet dental diseases and rising awareness for preventing painful dental conditions in pets.

About VELDONA® Pet

Based on Ainos' low-dose oral interferon-alpha ("IFNα") formulation, VELDONA® Pet are supported by multiple research studies and clinical trials and are manufactured with world-class materials in a highly certified plant. VELDONA® Pet aims to maintain immunity in cats and dogs by contributing to gum and skin health for allergy relief and stress reduction. Interferon is a substance naturally produced by an organism's body. When cells are invaded by foreign particles, immune signaling molecules notify neighboring cells. Once neighboring cells receive the interferon's protein signal through their surface receptors, they initiate and modulate the immune system to protect felines and canines from gum and skin diseases, allergies, and stress-related conditions.

An earlier clinical study sponsored by Ainos and conducted by the Agricultural Technology Research Institute in Taiwan has demonstrated that VELDONA® Pet helps maintain the immune systems of cats and dogs. VELDONA® Pet not only aims to provide protection against common and hard-to-diagnose diseases including FCGS, a severe oral mucosal inflammatory disease afflicting cats, and canine atopic dermatitis (CAD), an inflammatory skin disease found in dogs, but also aims to offer safe and high quality products on the market.

About FCGS

FCGS is characterized by severe inflammation of the gingiva, buccal mucosa, and caudal oral mucosa. There are two types of FCGS. Type 1 includes cases with alveolar and labial/buccal mucositis/stomatitis only, while Type 2 covers caudal mucositis/stomatitis, with or without alveolar and labial/buccal mucositis/stomatitis. As of now, the exact causes of FCGS remains unknown. Cats with FCGS seemingly have a hyperimmune reaction to plaque, bacteria, viruses, or environmental factors to lead to excessive inflammation. FCGS is a common condition in cats, with a reported prevalence ranging from 0.7% to 12.0%.

Currently, medical management of FCGS remains highly variable and often depends on comorbidities in each individual case. Generally, existing medical therapies for FCGS include antibiotics, antihistamines, and immunosuppressants, such as corticosteroids or cyclosporine, which are often first-line treatments for affected animals. However, these immunosuppressants have serious long-term side effects, including type 2 diabetes and opportunistic infections. Currently, no medications exist for animals that are unresponsive to anti-inflammatory or immunosuppressive treatments, and there are no ideal long-term solutions available for pet owners.

About Ainos, Inc.

Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on novel AI-powered point-of-care testing (POCT) and VELDONA low-dose interferon therapeutics. The Company's clinical-stage product pipeline includes VELDONA human and animal oral therapeutics, human orphan drugs, and telehealth-friendly POCT solutions powered by its AI Nose technology platform.

The name "Ainos" is a combination of "AI" and "Nose" to reflect the Company's commitment to empowering individuals to manage their health more effectively with next-generation AI-driven POCT solutions. To learn more, visit https://www.ainos.com.

Follow Ainos on X, formerly known as Twitter, (@AinosInc) and LinkedIn to stay up-to-date.

Safe Harbor Statement

Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements can be identified by the use of words such as "anticipate," "believe," "estimate," "approximate," "expect," "intend," "plan," "predict," "project," "target," "future," "likely," "strategy," "foresee," "may," "guidance," "potential," "outlook," "forecast," "should," "will" or other similar words or phrases. Similarly, statements that describe the Company's objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements are based only on the Company's current beliefs, expectations, and assumptions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. The Company's actual results may differ materially from those indicated in the forward-looking statements.

Important factors that could cause the Company's actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release include, among others, the cost of production and sales potential of the products announced in this press release; the Company's dependence on projected revenues from the sale of current or future products ; the Company's limited cash and history of losses; the Company's ability to achieve profitability; the Company's ability to raise additional capital to continue the Company's product development; the ability to accurately predict the future operating results of the Company; the ability to advance Ainos' current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates the Company develops; the ability to obtain and maintain regulatory approval of Ainos' product candidates; delays in completing the development and commercialization of the Company's current and future product candidates, which could result in increased costs to the Company, delay or limit the ability to generate revenue and adversely affect the business, financial condition, results of operations and prospects of the Company; intense competition and rapidly advancing technology in the Company's industry that may outpace its technology; customer demand for the products and services the Company develops; the accuracy of third-party market research data, the impact of competitive or alternative products, technologies and pricing; disruption in research and development facilities; lawsuits and other claims by third parties or investigations by various regulatory agencies governing the Company's operations; potential cybersecurity attacks; increased requirements and costs related to cybersecurity; the Company's ability to realize the benefits of third party licensing agreements; the Company's ability to obtain and maintain intellectual property protection for Ainos product candidates; compliance with applicable laws, regulations and tariffs; continued listing on and compliance with the applicable regulations of the Nasdaq Capital Market; and the Company's success in managing growth. A more complete description of these risk factors and others is included in the "Risk Factors" section of Ainos' Annual Report on Form 10-K for the year ended December 31, 2023, and other public filings with the U.S. Securities and Exchange Commission ("SEC"), many of which risks are beyond the Company's control. In addition to the risks described above and in the Company's filings with the SEC, other unknown or unpredictable factors also could cause actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release.

The forward-looking statements made in this press release are expressly qualified in their entirety by the foregoing cautionary statements. Any forward-looking statements contained in this press release represent Ainos' views only as of today and should not 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 update or revise any forward-looking statement to reflect changed assumptions, the occurrence of anticipated or unanticipated events or changes to the future results over time or otherwise, except as required by law.

Investor Relations Contact

Feifei Shen
Email: IR@ainos.com

SOURCE: Ainos, Inc.

View the original press release on accesswire.com

FAQ

What is the purpose of Ainos' clinical study for VELDONA-based animal drug?

The clinical study aims to evaluate the safety, tolerability, and efficacy of low-dose oral interferons in treating feline chronic gingivostomatitis (FCGS) in cats.

When is Ainos (AIMD) expected to complete enrollment for the FCGS clinical trial?

Ainos aims to complete the enrollment of 30 subjects for the FCGS clinical trial by the end of 2024.

What is the potential market size for Ainos' FCGS treatment in the United States?

Based on prevalence rates, it is estimated that between 5.8 to 8.3 million cats in the U.S. suffer from FCGS, representing a significant potential market for Ainos' treatment.

What is the projected growth of the global pet dental health market according to Ainos' press release?

According to Grand View Research, the global pet dental health market is projected to grow at a CAGR of 6.25% from 2023 to reach US$9.98 billion in 2030.