Virpax Pharmaceuticals Announces Results of Probudur™ Dose Escalation Studies
27 9월 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 results for two pre-clinical
Probudur™ dose escalation studies.
The first study compared Probudur to Exparel® utilizing a planar
incision model. Two doses of Probudur, at 3 mg and 6 mg, were
administered to rats. The results demonstrated three times longer
efficacy for Probudur than Exparel.
In the second study, two different formulations at the same dose
of Probudur were compared to Exparel in rat incision models. In
this study, Probudur demonstrated a four to five times longer
effect than the comparable product.
“These IND enabling studies confirmed our results from earlier
studies,” commented Anthony P. Mack, Chairman and CEO of Virpax
Pharmaceuticals. “We only have a few additional studies to be
performed and are on track to begin first-in-human trials of
Probudur in 2024.”
Additional confirmational studies for efficacy, toxicity, and
pharmacokinetics are ongoing with others planned in order for the
Company to file an Investigational New Drug (IND) Application.
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 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). 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, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, and Private Securities Litigation Reform Act, as amended,
including those described below. 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
Company’s anticipated studies for efficacy, toxicity and
pharmacokinetics, the Company’s filing of an IND Application, and
the Company’s anticipated first-in-human trials of Probudur™ in
2024. These statements relate to future events and involve known
and unknown risks, uncertainties, and other factors, including 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 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 has filed 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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version on businesswire.com: https://www.businesswire.com/news/home/20230927781607/en/
Investor Relations: Betsy
Brod Affinity Growth Advisors Betsy.brod@affinitygrowth.com (917)
923-8541 Media: Robert Cavosi
RooneyPartners rcavosi@rooneypartners.com (646) 638-9891
Virpax Pharmaceuticals (NASDAQ:VRPX)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024
Virpax Pharmaceuticals (NASDAQ:VRPX)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024