Virpax Reports Positive Results in Human Study for its Molecular Envelope Technology
27 Fevereiro 2025 - 6:01PM
Business Wire
Virpax Pharmaceuticals, Inc. (Nasdaq: VRPX) (“Virpax” or the
“Company”), 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, would like to congratulate Nanomerics on completing a
human study using the Molecular Envelope Technology (MET) and
showing no moderate to severe adverse events. Virpax uses MET in
its Envelta (NES100) and NobrXiol.
Envelta is an enkephalin drug product based on a type of
nanotechnology delivery approach. The MET is designed to protect
and help carry the drug to the brain with the goal of promptly
suppressing pain by binding to the delta opioid receptors. Envelta
has demonstrated analgesic potential in animal models without the
development of opioid tolerance or reward seeking behavior. It is
currently being developed in a cooperative research and development
agreement with the National Center for Advancing Translational
Sciences (NCATS), an institute/center of the National Institutes of
Health (NIH), U.S. Department of Health and Human Services.
In addition, Virpax uses MET with NobrXiol. NobrXiol is being
developed for delivery of cannabidiol in the management of epilepsy
in children and adults. NobrXiol utilizes the MET as its delivery
system to cross the blood brain barrier, propelling the cannabidiol
nanoparticles through the nose to the brain via the olfactory
nerve. The drug has received pre-Investigational New Drug (PIND)
application guidance from the U.S. Food and Drug Administration
(FDA)
Nanomerics’s Phase I trial, the SUNLIGHT trial, involved 28 days
of administration of OC134, powered by the MET and MET alone as eye
drops to healthy volunteers. Dosing twice daily (12 h apart) of the
healthy study participants with MET eye drops and OC134 eye drops
commenced in December 2024 and was completed in January 2025.
The SUNLIGHT trial was a phase I clinical trial; these trials
are used to test for the safety, side effects, best dose, and
timing of a new treatment. It may also test the best way to give a
new treatment (for example, by mouth, infusion into a vein, or
injection) and how the treatment affects the body.
All volunteers (n=10) completed the dosing schedule without
dropouts and volunteers will report for follow up assessments in
February 2025. There were no adverse events of moderate or severe
severity reported during the clinical phase of the trial and there
were no clinically significant individual changes from baseline or
notable trends in safety assessments including safety bloods, vital
signs, eye examination, 12 lead ECGs and urine analysis. The
topical administration of MET and OC134 eye drops on 56 consecutive
occasions were well tolerated by healthy volunteers under the
condition of the trial.
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 partners for 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
https://www.virpaxpharma.com.and follow us on Twitter, LinkedIn and
YouTube.
About Nanomerics
Nanomerics Ltd is a specialty pharmaceutical company with
state-of-the-art laboratories based in London, UK. Nanomerics was
founded to commercialise its biocompatible polymer technologies for
drug delivery and other applications. Nanomerics' proprietary
technology is based on world leading know-how and scientific
leadership in polymer nanotechnology. Nanomerics creates uniquely
differentiated, patented pharmaceutical assets, underpinned by high
quality science. For example, the company's Molecular Envelope
Technology (MET) is a unique patented biocompatible polymer that
delivers a step change in target tissue bioavailability. The
founding scientists, Professor Dame Ijeoma F. Uchegbu and Professor
Andreas G. Schätzlein developed the technology at the Universities
of Strathclyde and Glasgow and, latterly at the UCL School of
Pharmacy. Pharmaceutical product candidates in development include
the eye drops: OC134 for the treatment of moderate to severe
allergic conjunctivitis, OC137 for the treatment of retinal
diseases and OC135 for the treatment of glaucoma. For more
information, please visit www.nanomerics.com
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. These statements relate to future events
and involve known and unknown risks, uncertainties, and other
factors, 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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Investor: info@virpaxpharma.com
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