Virpax Announces Positive Results of Swine Model Pilot Study for Probudur™
July 10 2024 - 7:30AM
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 a Swine Model
pilot study for Probudur, Virpax’s long-acting liposomal
bupivacaine formulation injected at a wound site to provide both
immediate and extended pain relief.
The pharmacokinetics (PK) and safety study of Probudur in the
Swine Model was designed to determine the PK profile of Probudur as
well as to ascertain any adverse effects on the pigs. Probudur was
subcutaneously injected into 4 juvenile domestic pigs at a dose of
30 mg/kg and was well-tolerated by all of the pigs and demonstrated
a long-term, slow-release profile. Histopathology was also
conducted at the injection site and Probudur was well-tolerated by
all pigs in this study.
“Our study results to date for Probudur, as expected, have
consistently been positive and support our belief that Probudur has
the potential to provide both immediate relief as well as sustained
relief at the wound site,” stated Gerald Bruce, CEO of Virpax
Pharmaceuticals. “With our agreement to negotiate additional
funding from our new institutional investor, and remaining
necessary studies underway, we continue to target the end of the
year for filing our Investigational New Drug Application (IND) for
Probudur.”
Probudur is being developed to significantly reduce or eliminate
the need for opioids after surgery in approved indications.
Probudur is a local anesthetic that binds to the sodium channel,
preventing pain signals from reaching the brain. In pre-clinical
studies, Probudur has shown long duration pain control for at least
96 hours, with a rat incisional model demonstrating analgesia for
up to five days and in vitro studies demonstrating a slow release
of bupivacaine that lasted for up to six days.
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
one other prescription product candidate, NobrXiol™, which is 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 two of its prescription drug candidates,
one 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
as that term is defined in the Private Securities Litigation Reform
Act of 1995, 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 Probudur
having the potential to provide both immediate relief as well as
sustained relief at the wound site, continuing to target filing an
Investigational New Drug Application (IND) for Probudur by the end
of the year. These statements relate to future events and involve
known and unknown risks, uncertainties, and other factors,
including Probudur’s ability to provide both immediate relief as
well as sustained relief at the wound site, , the Company’s ability
to file an IND by the end of the year, to obtain FDA approval for
its prescription drug candidates and nonprescription drug
candidates; the Company’s ability to successfully complete research
and further development and commercialization of Company drug
candidates in current or future indications; the Company’s ability
to obtain additional grants to help fund upcoming clinical trials;
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 Company’s ability to obtain capital to
meet its current and long-term liquidity needs on acceptable terms,
or at all, including the additional capital which will be necessary
to complete studies and clinical trials that the Company plans to
initiate and other factors listed under "Risk Factors" in the
Company’s 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/20240710164147/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
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