Virpax to Use Envelta™ IND Enabling Study Results for Two Additional Indications
June 21 2021 - 08:00AM
Business Wire
Virpax® Pharmaceuticals, Inc. ("Virpax" or the "Company")
(NASDAQ: VRPX), today announced that the Investigational New Drug
(IND) Application enabling studies for Envelta™ being performed
under a Cooperative Research and Development Agreement (CRADA)
entered into by Virpax and the National Center for Advancing
Translational Sciences (NCATS) for chronic pain, will also be used
as a source for INDs for two additional indications, for cancer
pain and Post-Traumatic Stress Disorder (PTSD). NCATS has commenced
the IND enabling studies of Envelta to support Virpax’s future
application for clearance from the Food and Drug Administration
(FDA) to initiate Virpax’s first-in-human clinical trials.
Sheila Mathias, PhD, JD, Chief Scientific Officer of Virpax
stated, “Once the Envelta IND enabling studies are submitted to the
FDA for acute/chronic pain, the parent IND is expected to be used
to cross reference for the PTSD IND. We believe the same Phase I
Single Ascending Dose (SAD)/Multiple Ascending Dose (MAD) study
could be used to advance all three indications. SAD and MAD studies
are typically the first-in-human studies, where we seek to gain
information on safety and tolerability, general pharmacokinetic
(PK), and pharmacodynamic (PD) characteristics, and identify the
maximum tolerated dose.”
About Envelta
Envelta™ is an investigational intranasal formulation intended
to improve enkephalin transport to the brain. Enkephalin is a
naturally occurring (endogenous) peptide that is not easily
administered in its original form. Envelta™ uses a preassembled
device and cartridge to propel the enkephalin formulation through
the nose to the brain by flowing along the olfactory nerve pathway.
The Molecular Envelope Technology is designed to protect the drug
and help carry it to the brain, enabling it to cross the
blood-brain barrier to suppress pain by binding to the delta-opioid
receptors. Envelta™ has demonstrated analgesic potential in animal
models without developing opioid tolerance, withdrawal, respiratory
depression, euphoria, or addiction associated with the use of
opioids. Once the Envelta IND enabling studies are submitted to the
FDA, the data may be cross-referenced to our cancer pain and PTSD
INDs.
About Virpax Pharmaceuticals
Virpax is developing branded, non-addictive pain management
products candidates using its proprietary technologies to optimize
and target drug delivery. Virpax will initially seek 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, and PTSD. 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/20210621005055/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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