The FDA gave positive feedback regarding
filing a Biologics License Application (BLA) for Sjögren's syndrome
following two Phase 3 studies
Ainos is seeking out-licensing opportunities
to accelerate the process of bringing five new drug candidates to
Phase 3 trials and eventual commercialization
SAN
DIEGO, Nov. 3, 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 is pursuing
out-licensing opportunities for five new drug candidates for its
low-dose oral interferon-alpha ("IFNα") formulation,
VELDONA®. Ainos has completed Phase 2 trials for the
five new drug candidates and will work with potential partners to
accelerate the candidates to Phase 3 trials and eventual
commercialization of VELDONA®. For more information,
please visit https://www.ainos.com/.
FDA feedback on the efficacy of the Company's new drug candidate
for treating Sjögren's syndrome has been promising following two
Phase 3 results.
Ainos' low-dose oral VELDONA® formulation is designed
to enhance a patient's immune response and boost their ability to
fight viral infections, while also potentially reducing the side
effects and risks caused by high-dose interferons and other small
molecule drugs. The following five indications have completed Phase
2 trials and showed positive effects of oral VELDONA®
treatment. Ainos aims to enter out-licensing agreements to advance
VELDONA® to Phase 3 trials and
commercialization.
- Sjögren's syndrome (US IND No. 5700): After 48 weeks of
treatment, the clinical results showed increased unstimulated whole
saliva and improvements in mouth dryness and seven other SS
symptoms. The FDA provided promising feedback on the efficacy of
this treatment over the course of two Phase 3 results.
- Aphthous Stomatitis (US IND No. 5126): The clinical results
showed clearance of existing lesions and reduced severity of new
lesions.
- Chemotherapy-induced Stomatitis (US IND No. 5587): The clinical
results showed reduced severity during repeat chemotherapy.
- Influenza (Australian ACTRNACTRN12609000976280): The clinical
results showed reduced incidence of moderate to severe symptoms;
remission of sore throat, fever and head congestion; and
significantly reduced influenza-like illness rate in three
subgroups: 50 year and older, those vaccinated against seasonal
flu, and males.
- Common Cold (US IND No. 5244): The clinical results showed
immediate reduction of malaise and sore throat after 6 hours from
initial treatment.
The Company's product is delivered into the oral cavity as a
lozenge in low (nanogram) doses. Human studies have shown that IFNα
given orally is effective against viral and autoimmune diseases,
without the side effects associated with high-dose injections of
IFNα. Ainos has cumulatively spent nearly $40 million on developments related to the oral
use of IFNα (VELDONA® formulation), not including the
expected expenses on clinical trials and manufacturing
VELDONA®. To date, 68 clinical trials have been
conducted with low-dose oral IFNα. Sixty-three studies were Phase 2
trials, and three Phase 1 and two Phase 3 studies have also been
conducted. Nearly 6,000 patients with one of 16 different disease
indications and/or healthy volunteers participated in these trials,
including a total of 4,600 subjects exposed to IFNα at a dose level
ranging from three to 2,000 international units given daily for up
to five years. The safety of orally administered IFNα has been
consistently demonstrated in these trials.
Interferons are proteins made by host cells in response to the
presence of pathogens such as viruses, bacteria, parasites, or
tumor cells. They allow for communication between cells to trigger
the protective defenses of the immune system that eradicate
pathogens or tumors. Of the nine different families of human
interferon that have been identified, interferon-alpha is the most
widely studied. The US FDA has approved the use of IFNα in mega
doses given by injection for treating a number of cancers, as well
as Hepatitis B and C.
Chun-Hsien Tsai, Ainos' Chairman of the Board, President, and
Chief Executive Officer, commented, "The Phase 3 results of the new
drug candidate for Sjögren's syndrome is an effective demonstration
of the potential VELDONA® treatment holds for other
indications. Low-dose oral interferon-alpha treatments have
previously shown a promising array of potential applications
through Phase 2 clinical trials, and we recently carried out
studies that demonstrated VELDONA®'s effectiveness in
protecting against symptoms associated with COVID-19 and prevention
and treatment of influenza. By exploring out-licensing
opportunities for our five VELDONA® new drug candidates,
we plan to accelerate commercialization of our VELDONA®
technology as rapidly as possible."
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.