Virpax Pharmaceuticals Files Provisional Patent Application for Intranasal Delivery
July 13 2023 - 7:58AM
Business Wire
Virpax® Pharmaceuticals, Inc. (“Virpax” or the
“Company”) (NASDAQ: VRPX), a company specializing in developing
non-addictive products for pain management, post-traumatic stress
disorder, central nervous system (CNS) disorders and viral barrier
indications, today announced that it has filed a new provisional
patent application with the United States Patent and Trademark
Office (‘USPTO’) entitled “Intranasal Delivery” related to its
Envelta™ product candidate.
Envelta utilizes Molecular Envelope Technology (‘MET’) for the
delivery of Enkephalin intranasally for severe cancer pain and
non-cancer pain. The enkephalin/MET formulation is delivered using
a delivery device which propels the formulation into nose such that
the enkephalin is delivered to the brain. MET was developed by
Nanomerics Ltd., a UK-based nanotechnology research and development
company. Nanomerics has licensed its technology to Virpax, which is
utilizing the nose-to-brain MET platform to enhance drug delivery
for certain of its product candidates including Envelta. The
development program for Envelta is being funded almost exclusively
through a Cooperative Research and Development Agreement (‘CRADA’)
with the National Center for Advancing Translational Sciences
(‘NCATS’), part of the National Institute of Health.
“We are pleased with the continued development of our patent
portfolio for Envelta,” stated Anthony P. Mack, Chairman and CEO of
Virpax. “Recent toxicology studies for MET performed by NCATS on
dogs demonstrated evidence of delivery of Envelta to the brain. We
are utilizing this technology for a number of our programs as we
believe the nose to brain intranasal drug delivery pathway, which
avoids the blood-brain barrier, will lessen drug-to drug
interaction and reduce drug dosing.”
About Virpax Pharmaceuticals
Virpax is developing branded, non-addictive pain management
products candidates using its proprietary technologies to optimize
and target drug delivery. Virpax is initially seeking FDA approval
for two prescription drug candidates that employ two different
patented drug delivery platforms. Probudur™ is a single injection
liposomal bupivacaine formulation being developed to manage
post-operative pain and Envelta™ is an intranasal molecular
envelope enkephalin formulation being developed to manage acute and
chronic pain, including pain associated with cancer. Virpax is also
using its intranasal Molecular Envelope Technology (MET) to develop
two other product candidates. PES200 is a product candidate being
developed to manage post-traumatic stress disorder (PTSD) and
NobrXiol™ is a product candidate being developed for the nasal
delivery of a pharmaceutical-grade cannabidiol (CBD) for the
management of rare pediatric epilepsy. Virpax recently acquired
global rights to NobrXiol. Virpax is also seeking approval of two
nonprescription product candidates: AnQlar, which is being
developed to inhibit viral replication caused by influenza or
SARS-CoV-2, and Epoladerm™, which is a topical diclofenac spray
film formulation being developed to manage pain associated with
osteoarthritis. For more information, please visit virpaxpharma.com
and follow us on Twitter, LinkedIn and YouTube.
Forward-Looking Statements
This press release contains certain forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934 and Private
Securities Litigation Reform Act, as amended, including those
relating to the Company's planned clinical trials, product
development, clinical and regulatory timelines, market opportunity,
competitive position, possible or assumed future results of
operations, business strategies, potential growth opportunities and
other statements that are predictive in nature. These
forward-looking statements are based on current expectations,
estimates, forecasts and projections about the industry and markets
in which we operate and management's current beliefs and
assumptions.
These statements may be identified by the use of forward-looking
expressions, including, but not limited to, "expect," "anticipate,"
"intend," "plan," "believe," "estimate," "potential,” "predict,"
"project," "should," "would" and similar expressions and the
negatives of those terms and include statements regarding the
continued development of our patent portfolio for Envelta and the
nose to brain intranasal drug delivery pathway, which crosses the
blood-brain barrier, lessening drug-to drug interaction and reduce
drug dosing. These statements relate to future events or the
Company’s financial performance and involve known and unknown
risks, uncertainties, and other factors, including the ability to
continue the development of the patent portfolio, the ability of
the nose to brain intranasal drug delivery pathway to lessen
drug-to drug interaction and reduce drug dosing, the Company’s
ability to successfully complete research and further development
and commercialization of Company drug candidates in current or
future indications; the uncertainties inherent in clinical testing;
the Company’s ability to manage and successfully complete clinical
trials and the research and development efforts for multiple
product candidates at varying stages of development; the effects of
the outbreak of COVID-19 on the Company’s business and results of
operations; the timing, cost and uncertainty of obtaining
regulatory approvals for the Company’s product candidates; the
Company’s ability to protect its intellectual property; the loss of
any executive officers or key personnel or consultants;
competition; changes in the regulatory landscape or the imposition
of regulations that affect the Company's product candidates; the
Company’s ability to continue to obtain capital to meet its
long-term liquidity needs on acceptable terms, or at all, including
the additional capital which will be necessary to complete clinical
trials that the Company plans to initiate; and other factors listed
under "Risk Factors" in our annual report on Form 10-K and
quarterly reports on Form 10-Q that the Company files with the U.S.
Securities and Exchange Commission. Prospective investors are
cautioned not to place undue reliance on such forward-looking
statements, which speak only as of the date of this press release.
The Company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise.
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Betsy Brod Affinity Growth Advisors
betsy.brod@affinitygrowth.com 212-661-2231
Virpax Pharmaceuticals (NASDAQ:VRPX)
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