Ainos to Initiate Clinical Study of New Potential VELDONA-Based Animal Drug, Expanding VELDONA's Potential Market
Ainos announced a clinical study for a new VELDONA-based drug aimed at treating feline chronic gingivostomatitis (FCGS). The study will evaluate the efficacy of low-dose oral interferons and is expected to run from May 24, 2024, to March 31, 2025. This initiative follows a Memorandum of Understanding with SIDSCO Biomedical and aims to expand Ainos' presence in the pet care market. VELDONA, initially approved in 1985 for feline leukemia and canine parvovirus, has shown systemic effects in various species, making it a promising candidate for FCGS treatment. The trial will include 30 cats and assess health improvements and potential steroid dosage reductions.
- Initiation of a clinical study for a potential new drug targeting FCGS, expanding VELDONA's application.
- Study duration set from May 24, 2024, to March 31, 2025, with clear timelines.
- Ainos has a history of 28 studies confirming VELDONA's efficacy in various species.
- Potential to reduce the need for steroids or other immunosuppressive drugs in treating FCGS.
- VELDONA has demonstrated systemic effects without serious side effects.
- Positive market expansion into the growing pet care sector, leveraging an established product.
- Clinical trials are expected to take ten months, delaying potential market availability.
- The study involves only 30 cats, which may limit the generalizability of results.
- There are no current safe long-term pharmaceutical treatments for FCGS, indicating high-risk, high-reward potential.
- Previous successes in animal health do not guarantee success in this new application.
Insights
The decision by Ainos to initiate a clinical study for a new potential VELDONA-based drug targeting feline chronic gingivostomatitis (FCGS) represents a significant development in the field of veterinary medicine. This moves beyond VELDONA’s historical use in treating conditions like feline leukemia and canine parvovirus, reflecting an effort to leverage its systemic effects to manage chronic inflammatory diseases in pets. Currently, there are no long-term pharmaceutical treatments available for FCGS, which is indicative of an unmet need in the market.
From a clinical perspective, the use of low-dose oral interferons aims to modulate the immune system locally in the oral mucosa, potentially reducing systemic side effects associated with interferons. This targeted approach could offer significant improvements in both the quality of life for affected cats and in the long-term management of the disease.
Animal studies have previously shown that oral interferons can be distributed effectively to lymph nodes in the head and neck, which is important for modulating immune responses without causing systemic immunogenicity or bone marrow suppression. This localized effect is particularly promising for FCGS, a disease associated with immune system dysregulation.
The expansion of VELDONA into the pet care market aligns well with the broader trend of increased spending on pet health and wellness. The pet care market has seen significant growth in recent years, driven by a rise in pet ownership and a willingness among pet owners to invest in advanced treatments for their animals. With the prevalence of FCGS in cats ranging from 0.7% to 12%, there is a substantial potential customer base for an effective treatment, highlighting a lucrative opportunity for Ainos.
Given the historical efficacy of VELDONA in animal health and its versatile application across various species, the move to address FCGS could strengthen Ainos' position in the veterinary therapeutics market. The company's strategic collaboration with SIDSCO Biomedical Co., Ltd. further supports their market expansion goals, suggesting a well-coordinated approach to navigating regulatory pathways and market entry.
For investors, Ainos' initiation of this clinical study is a positive signal. The company is strategically diversifying its product offerings and tapping into a growing market segment. Financially, successful results from this study could potentially translate into a new revenue stream. The global pet care market is booming and a new effective treatment for FCGS would likely attract significant demand.
The ten-month timeline for clinical trials is relatively short in the pharmaceutical development cycle, suggesting that if results are positive, Ainos could move quickly toward commercialization. This could positively impact the company’s revenue and profitability in the near to medium term, especially if the treatment gains rapid adoption among veterinarians and pet owners.
Investors should, however, keep an eye on the trial outcomes and subsequent regulatory approvals. The company's ability to navigate these stages without significant setbacks will be critical to realizing the potential financial benefits discussed.
Study to evaluate clinical effectiveness of low-dose oral interferons in treating chronic gingivostomatitis in cats, building upon VELDONA's history in animal health since 1985
Clinical trials are expected to run for approximately ten months from May 24, 2024.
SAN DIEGO, CA / ACCESSWIRE / May 15, 2024 / Ainos, Inc. (NASDAQ:AIMD, AIMDW) ("Ainos", or the "Company"), a diversified healthcare company focused on the development of novel point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced the initiation of a clinical study for a new potential VELDONA®-based drug for pet disease. The study is aimed at evaluating the clinical efficacy of low-dose oral interferons in treating feline chronic gingivostomatitis ("FCGS"), a serious and chronic painful oral disease characterized by inflammation or abnormal proliferation in the oral cavity.
This marks another meaningful step in the Company' s strategy for expanding its product line into the global pet care market, which follows the Memorandum of Understanding Ainos signed last year with SIDSCO Biomedical Co., Ltd. The clinical trials are expected to run for approximately ten months from May 24, 2024 to March 31, 2025.
Current research suggests that FCGS results from multiple factors, including dental diseases, viral and bacterial pathogens, and environmental conditions, with a reported prevalence ranging between
Ainos' VELDONA®, a low-dose oral interferon alpha ("IFNα") formulation, was initially approved by the Texas Department of Health in 1985 for treating feline leukemia in cats and canine parvovirus in dogs. Ainos has conducted 28 studies, in which VELDONA® demonstrated systemic effects across various animal species including mice, cats, dogs, ferrets, chickens, rats, guinea pigs, horses, calves/cows, and particularly, pigs. These studies highlight the therapeutic or preventive capabilities in VELDONA® through oral mucosa, alongside systemic and mucosal immunity modulation without serious side effects.
Previous studies have confirmed that interferon administered through the oral mucosa can modulate partial immune system in experimental animals. Furthermore, interferon administered is shown by imaging to be prominently distributed in the lymph nodes of the head and neck, and in some cases, even reaching the lymphatic system surrounding the mesentery. Since the FCGS belongs to diseases of immune system dysregulation, partial oral mucosal administration not only modulates the disordered immune system but also avoids the associated systemic side effects of interferon use, such as immunogenicity and bone marrow suppression.
Ainos's study will involve a randomized, controlled trial with 30 cats divided into two groups: one receiving low doses (6000 IU/time) of the treatment and the other for high doses (12000 IU/time). The main objective is to demonstrate significant health assessment improvements made by both pet owners and veterinarians before and after the treatment. The trials will also evaluate the potential in reducing dosage and frequency of steroids or other immunosuppressive drugs.
Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and Chief Executive Officer of Ainos, commented "Animal health has been an important part of VELDONA's development history since 1985, we're excited to take another significant step in advancing VELDONA® in the pet health sector. With the burgeoning growth of the pet care market, there's never been a better time for us to study a potential treatment and broaden our VELDONA® offerings to address one of the most prevalent issues among cats. We are dedicated to expediting the animal drug development process through this pioneering clinical study, and we will remain steadfast in our commitment to providing safe and efficient solutions for our animal companions."
About Ainos, Inc.
Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on the development of novel point-of-care testing (POCT), low-dose VELDONA® interferon therapeutics, and synthetic RNA-driven preventative medicine. The company's products include VELDONA® clinical-stage human therapeutics, VELDONA® Pet cytoprotein health supplements, and telehealth-friendly POCTs powered by its AI Nose technology platform. The lead POCT candidate, Ainos Flora, is intended to be a telehealth-friendly POCT for women's health and certain common STIs. To learn more, visit https://www.ainos.com.
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Safe Harbor Statement
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," "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 reports filed 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 reports filed 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.
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