Virpax Pharmaceuticals Announces that Envelta™ Remains on Track for Trial in Humans Following FDA Review
31 10월 2023 - 9:58PM
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 anti-viral
barrier indications, today announced that it expects to submit an
Investigational New Drug Application (IND) for Envelta in mid-2024
following review of comments made by the US Food and Drug
Administration on the Company’s Pre-IND submission. If successful,
that would allow clinical trials to begin by the middle of
2024.
Envelta (MET-LENK) is the Company’s non-addictive pain product
candidate for acute and chronic pain that is being funded under an
in-kind grant from the National Center for Advancing Translational
Sciences (NCATS), part of the National Institutes of Health (NIH).
Envelta utilizes a novel and patented intranasal drug delivery
system, Molecular Envelope Technology (MET) to bypass the
blood-brain barrier. The MET was developed by Nanomerics, Ltd., a
UK-based nanotechnology research and development company that has
licensed its MET-LENK to Virpax. The nose-to-brain MET platform
protects molecules from biodegrading and enhances the
bioavailability of product candidates on its transport to the
brain.
The initial Envelta dose ranging studies in rats and dogs have
been completed. The 14-day rat dose range finding study (DRF)
showed no treatment related clinical signs or mortality. In
addition, there were no related findings in hematology,
coagulation, and serum chemistry data. The 14-day DRF study in dogs
also showed no treatment related mortality or findings in body
temperature, body weight, food consumption, and ophthalmic exam.
From an efficacy perspective, a dose-response with intranasal
MET-LENK was noted in a Complete Freund’s Adjuvant (CFA)
anti-hyperalgesia model versus an intranasal placebo and
subcutaneous morphine. Administration of the high dose MET-LENK (30
mg/kg) significantly decreased hypersensitivity in treated animals
compared to CFA control.
“There is a significant unmet need for effective analgesics with
limited or no abuse potential. Our research on Envelta suggests
that there is a clear efficacy signal with minimal adverse effects
noted in animals in all of our head-to-head comparisons to
morphine. Using our novel MET, leucine-enkephalin can be delivered
to the brain via an intranasal formulation of nanoparticles which
helps to protect from biodegradation. If human data confirms
analgesic benefit without drug tolerance or drug-seeking behavior,
this formulation may represent a potential broad-spectrum molecule
to treat severe pain and CNS disorders,” stated Anthony P. Mack,
Chairman and CEO of Virpax. “We are grateful to the FDA for the
thorough and clear direction that was provided to us in our pre-IND
meeting. With the ongoing support of our NIH colleagues, we expect
to continue advancing Envelta through preclinical development
leading up to first in human trials in 2024.”
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 has competitive
cooperative research and development agreements (CRADAs) for all
three of its prescription drug candidates, two with the National
Institutes of Health (NIH) and one with the Department of Defense
(DOD). Novvae™ Pharmaceuticals, a wholly-owned subsidiary of
Virpax, is developing over-the-counter (OTC) products using
innovative metered-dose drug delivery platforms. Novvae is seeking
approval of AnQlar which is being developed to inhibit viral
replication caused by influenza or SARS-CoV-2.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
submitting an Investigational New Drug Application for Envelta in
mid-2024, beginning clinical trials by the middle of 2024, research
on Envelta suggesting that there is a clear efficacy signal with
minimal adverse effects noted in animals in head-to-head
comparisons to morphine, human data confirming analgesic benefit
without drug tolerance or drug-seeking behavior, the formulation
representing a potential broad-spectrum molecule to treat severe
pain and CNS disorders and continuing to advance Envelta through
preclinical development. These statements relate to future events
or the Company’s financial performance and involve known and
unknown risks, uncertainties, and other factors, including the
impact of any damages or remedies awarded in the additional
proceedings of the lawsuit filed in the Delaware Chancery Court
against the Company; the Company’s ability to successfully begin
trials when expected and 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 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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Investor Relations Contact:
Betsy Brod Affinity Growth Advisors Betsy.brod@affinitygrowth.com
(917) 923-8541 Media Contact:
Robert Cavosi RooneyPartners rcavosi@rooneypartners.com (646)
638-9891
Virpax Pharmaceuticals (NASDAQ:VRPX)
과거 데이터 주식 차트
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Virpax Pharmaceuticals (NASDAQ:VRPX)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024