VELDONA® interferon-alpha formulation has shown potential as a treatment candidate for feline chronic gingivostomatitis and canine atopic dermatitis
Ainos advances its product pipeline as it targets commencing clinical studies during the second quarter of 2023
SAN DIEGO, Nov. 21, 2022 /PRNewswire/ — Ainos, Inc. (NASDAQ: AIMD, AIMDW) (“Ainos”, or the “Company”), a diversified medtech company focused on the development of novel point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced that it has published preclinical data demonstrating the potential of its low-dose oral interferon-alpha (IFNα) formulation, VELDONA®, as treatment candidates for the two most common medical conditions for dogs and cats. The preclinical data can be accessed here.
Ainos intends to begin clinical studies to assess VELDONA®’s potential use in the treatment of feline chronic gingivostomatitis (FCGS) and canine atopic dermatitis (CAD) during the second quarter of 2023. The Company initially applied VELDONA® to feline coronavirus (FCoV)-infected fcwf-4 (feline microphage) systems to determine potency and dose translation. According to the results, the EC50 value of VELDONA® was 1062 IU/mL (5.29×10-3 ng/ml). Based on VELDONA®’s effective antiviral efficacy, the Company is planning an expansion of its use for the treatment of humans to treatment of animals. Ainos is designing dose-finding field studies to identify optimal VELDONA® dose via oromucosal administration for feline FCGS and canine CAD.
A report compiled by Research and Markets and published by Mordor Intelligence shows that the global pet dental health market is projected to grow at a CAGR of 6.2%, reaching US$9.98 billion by 2030. The dog market segment accounted for the largest revenue share at over 55.0%, and the cat market segment is anticipated to expand at a CAGR of 6.9%. It is also reported that the global CAD market size is projected to grow at a CAGR of 12.6% to reach US$221.20 billion by 2027.
FCGS is a severe oral mucosal inflammatory disease afflicting cats, while CAD is an inflammatory skin disease found in dogs. Both of these diseases are common, difficult to diagnose, and have complex multifactorial etiologies, with complex causes including environmental factors, bacterial or viral infections, and aberrant host immune systems. Once infected, the host animal will display an inappropriate immune response which may require life-long medication to control.
Estimates of the prevalence of FCGS among cats range from 0.7% to 12% and the prevalence of CAD among dogs is estimated to be between 3% and 15%. The estimated ownership of cats and dogs in the U.S. numbers 85.5 million and 78 million respectively, suggesting up to 10.3 million cats suffer from FCGS and up to 11.7 million dogs suffer from CAD. The rate of companion animal ownership in the U.S. continues to increase, especially among young people. Approximately 44% of all U.S. households have a dog and 35% of U.S. households have a cat.
Presently, medical management of FCGS and CAD remains highly diverse, and is often dependent upon comorbidities in individual cases. In general, existing pharmacotherapies for FCGS and CAD include antibiotics, antihistamines, and immunosuppressive agents such as corticosteroids or cyclosporine, which are often the first line of treatment for afflicted animals. However, the long-term adverse effects of these immunosuppressive agents are serious, and include type II diabetes and opportunistic infections. At present, no medication exists for animals that are not responsive to anti-inflammatory or immunosuppressive treatments, and there is no ideal long-term solution available to pet owners.
Over the course of several years, the Company’s VELDONA® formulation exhibited systemic effects in mice, cats, dogs, rats, guinea pigs, horses, cattle, and swine, involving such indications as feed efficiency in swine and lethal virus infection in other species (e.g., canine parvovirus, horse herpes virus, and feline coronavirus). These in vivo studies indicate that VELDONA® can have a therapeutic or prophylactic effect at sites distal to the oral mucosa. VELDONA® modulates systemic and mucosal immunity in the absence of serious adverse effects, first-pass effect and proteolytic degradation associated with other administration routes.
Chun-Hsien Tsai, Ainos’ Chairman of the Board, President, and Chief Executive Officer commented, “Following our acceleration of five VELDONA® candidates to Phase 3 trials and commercialization, this preclinical data indicates the formulation’s promising potential for an array of applications. It also demonstrates that we are successfully executing on our strategy to broaden VELDONA®’s market, and our progress in advancing the monetization of our innovative product pipeline. More and more people are taking to pet ownership, and it has become all the more important that pet owners have access to safe and effective solutions for their animals’ medical issues. As we look ahead to the process of conducting clinical trials to assess VELDONA®’s potential use in the treatment of FCGS and CAD, we are proud to be able to offer a potential treatment for two conditions that combined affect millions of creatures.”
About Ainos, Inc.
Headquartered in San Diego, California, Ainos, Inc. (f/k/a Amarillo Biosciences, Inc.) is a diversified medtech company engaged in developing innovative medical technologies for point-of-care testing and safe and novel medical treatment for a broad range of disease indications. In addition to its proprietary therapeutics using low-dose non-injectable interferon, Ainos is committed to developing a comprehensive healthcare business portfolio encompassing medical devices and consumer healthcare products. While prioritizing the commercialization of medical devices as part of its diversification strategy, Ainos has also expanded its product portfolio to include Volatile Organic Compounds (VOC) and COVID-19 POCTs. Leveraging its patents related to VOC technologies and COVID-19 POCT products, the Company seeks to expedite the commercialization of its medical device pipeline, beginning with Ainos-branded COVID-19 POCT product candidates.
This press release contains “forward-looking statements” about Ainos within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as “anticipate,” “believe,” “estimate,” “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 planned drug treatments announced in this press release; the Company’s dependence on revenues from the sale of COVID-19 test kits; 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 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; and the Company’s success in managing the growth. A more complete description of these risk factors and others is included in the “Risk Factors” section of Ainos’ most recent Annual Report on Form 10-K/A and other reports filed with the U.S. Securities and Exchange Commission, many of which risks are beyond the Company’s control. In addition to the risks described above and in the Company’s Form 10-K/A, 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. 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.
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