Virpax Pharmaceuticals Provides Progress Update on Product Candidates
July 07 2021 - 9:00AM
Business Wire
Virpax® Pharmaceuticals Inc. ("Virpax" or the "Company")
(NASDAQ:VRPX), today is providing a progress update on its pipeline
of product candidates following the Company’s initial public
offering (the “IPO”) in mid-February of 2021.
Chairman and CEO Anthony P. Mack commented, “Our goal following
our IPO was to become a clinical stage company as quickly as
possible while preserving our cash and utilizing grants to fund
product development efforts where appropriate. To date, I believe
we have made solid progress towards these goals. We are making
refinements to some formulations which we believe will improve
manufacturability, and possibly extend patent life. We are also
evaluating additional indications for our unique delivery
technologies. Finally, we plan to begin initial Investigational New
Drug Application ("IND") enabling studies shortly on several of our
existing programs and recently submitted a pre-IND briefing
document to the U.S. Food and Drug Administration (“FDA”) for
MMS019, our intranasal molecular masking spray.”
Epoladerm™
Epoladerm is Virpax’s metered-dose diclofenac spray film product
candidate that is currently being evaluated for two indications,
acute musculoskeletal pain and chronic osteoarthritis of the knee
pain (OSF200). The Company will begin a series of IND enabling
toxicity studies which are expected to take from eight months to
one year to complete. Upon successful completion of these studies,
the Company intends to submit an IND application to the FDA,
including a trial design for a Phase I study.
For the chronic osteoarthritis pain of the knee indication,
Virpax is planning to conduct a Phase I study to evaluate the
relative bioavailability, pharmacokinetics, and safety of its
product candidate, OSF200, compared with Pennsaid topical solution.
No date for trial initiation or timeline has been determined for
OSF200 at this time.
Probudur™
Probudur is Virpax’s injectable bupivacaine liposomal hydrogel
for postoperative pain management, which we believe to have
improved onset and extended duration of action compared to existing
treatment options. Charles River Laboratories has been engaged to
perform seven preclinical animal studies during the second half of
2021, including method, dosage, and toxicity as part of the
required FDA enabling trials for an IND for Probudur. However, the
Company has elected to strategically delay these trials in order to
enhance the formulation of Probudur to increase stability for
manufacturing purposes and to possibly extend the lifetime of a
relevant patent.
Envelta™
Envelta is Virpax’s endogenous enkephalin intranasal spray for
acute and chronic pain, including pain associated with cancer. The
IND enabling studies for Envelta are being performed under a
Cooperative Research and Development Agreement (“CRADA”) entered
into by Virpax and the National Center for Advancing Translational
Sciences (“NCATS”). The Company recently announced that it intends
to use these studies as a source for INDs for two additional
potential indications, cancer pain and Post-Traumatic Stress
Disorder. To date, 2 of the 4 planned initial in vitro studies have
been successfully completed. These pre-clinical studies under the
CRADA will be conducted through 2021 and early 2022.
MMS019
MMS019 is Virpax’s high-density intranasal molecular masking
spray being developed as an anti-viral barrier that will be used as
an adjuvant to barrier-based personal protective equipment. The
Company recently announced that results from an animal study of
MMS019 demonstrated inhibited viral replication and decreased
levels of virus in animal brain tissue. Virpax engaged Syneos
Health to assist with the regulatory pathway and drug development
trials required to file an NDA for FDA approval. The Company has
submitted a pre-IND briefing package to the FDA.
“We remain excited about the opportunities that we have ahead of
us. We will be providing additional newsworthy information through
our filings with the SEC or through news releases,” concluded Mr.
Mack.
About Virpax Pharmaceuticals
Virpax is developing branded, non-addictive pain management
product candidates using its proprietary technologies that optimize
target drug delivery. Virpax is initially seeking FDA approval
using its three patented drug delivery platforms. Epoladerm™ is a
topical diclofenac metered-dose spray film formulation being
developed to manage acute musculoskeletal pain and osteoarthritis.
Probudur™ is a single injection liposomal bupivacaine formulation
being developed to manage post-operative pain. 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 its PES200 product
candidate to manage post-traumatic stress disorder (PTSD) and its
MMS019 product candidate to inhibit viral replication caused by
influenza or SARS-CoV-2. For more information, please visit
www.virpaxpharma.com.
Forward-Looking Statement
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. These statements relate to future events
or our financial performance and involve known and unknown risks,
uncertainties, and other factors, including the potential impact of
the recent COVID-19 pandemic and the potential impact of sustained
social distancing efforts, on the Company’s operations, clinical
development plans and timelines, which may cause actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements. Such factors include those set
forth in the Company's filings with the 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/20210707005225/en/
Christopher M. Chipman, CPA Chief Financial Officer
cchipman@virpaxpharma.com 610-727-4597
Or
Betsy Brod Affinity Growth Advisors
betsy.brod@affinitygrowth.com 212-661-2231
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