Virpax Announces Results of Maximum Tolerated Dose Study for Probudur™
April 30 2024 - 7:30AM
Business Wire
-Liposomal Formulation Developed to Provide
Both Immediate and Sustained Pain Relief-
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 Maximum
Tolerated Dose (MTD) study in Sprague-Dawley Rats for
Probudur™.
Probudur is Virpax’s injectable long-acting liposomal
bupivacaine formulation that is injected at the wound site.
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
trials, 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.
The study was designed to determine the MTD of free bupivacaine,
Probudur, and Probudur plus free bupivacaine when administered as a
single subcutaneous injection to the wound. Probudur, with its
liposomal formulation, is intended to provide both immediate and
extended pain relief at the wound site. The dosing ranges were
selected based on a prior preliminary study. All doses of Probudur
were well-tolerated. There were no noteworthy effects on body
weight, clinical chemistry, hematology, or coagulation. It was also
observed that bupivacaine appears to be less toxic in the presence
of liposomes than when administrated as a free drug.
Histopathology was conducted on the injection site and all
treatment groups showed some changes which were minimal to moderate
in severity. Effects were slightly more pronounced at the high dose
of Probudur. In vivo MTD studies in rats indicated that Probudur
provided a better therapeutic window as compared to free
bupivacaine.
“These results confirm our belief that Probudur is
well-tolerated in animals and a single injection of this
proprietary liposomal formulation of bupivacaine has the potential
to provide both immediate relief as well as sustained relief at the
wound site,” stated Gerald Bruce, CEO of Virpax Pharmaceuticals.
“Probudur’s proprietary formulation allows for both rapid onset and
prolonged duration of action, obviating the need for simultaneous
administration of free bupivacaine. We are now another step closer
to completing our required preclinical studies and plan to file an
Investigational New Drug Application (IND) for Probudur by the end
of the year.”
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
significantly reducing or eliminating the need for opioids after
surgery in approved indications, Probudur providing immediate pain
relief at the wound site, as well as extended support for pain
reduction, Probudur being well-tolerated in animals and that a
single injection of this proprietary liposomal formulation of
bupivacaine having the potential to provide both immediate relief
as well as sustained relief at the wound site, being another step
closer to completing required preclinical studies and filing an
Investigational New Drug Application (IND) for Probudur by the end
of the year, subject to adequate financing. These statements relate
to future events and involve known and unknown risks,
uncertainties, and other factors, including the Probudur’s ability
to significantly reduce or eliminate the need for opioids after
surgery in approved indications, 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 maintain competitive cooperative research
and development agreements (CRADAs) for its prescription 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 move ahead with remaining confirmational
studies for Probudur as planned; 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/20240429015636/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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