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 (5.29x10-3 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.
Forward-Looking Statements
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.
Investor Relations Contact
ICR, LLC
Robin Yang
Tel: +1 646-224-6971
Email: Ainos.IR@icrinc.com
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SOURCE Ainos, Inc.