Virpax’s NES100 to be Presented at The Society of Toxicology by NCATS

Rhea-AI Summary

Virpax Pharmaceuticals (NASDAQ: VRPX) announced that its NES100 dose range finding toxicity study will be presented at The Society of Toxicology 64th annual meeting in Orlando, FL, March 16-20th. The company has received an extension of its research agreement with the National Center for Advancing Translational Sciences (NCATS) for NES100's development.

NES100 is an intranasal enkephalin-based peptide designed for acute and chronic non-cancer pain management. The product utilizes nanotechnology delivery through the upper nasal cavity, bypassing the blood-brain barrier via olfactory neurons. The Molecular Envelope Technology (MET) helps deliver the drug directly to the brain, targeting delta opioid receptors for pain suppression.

Notably, animal studies have shown analgesic effects without typical opioid-related complications such as tolerance, withdrawal, respiratory depression, euphoria, or addiction.

Positive

• Non-addictive pain management solution with potential advantages over traditional opioids
• Successful demonstration of analgesic effects in animal models without opioid-related complications
• Novel drug delivery system bypassing blood-brain barrier
• Extended research agreement with National Institutes of Health (NIH) division

Negative

• Product still in early development phase
• No human clinical trial data available yet
• Pending regulatory approvals and further studies needed

BERWYN, Pa.--(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, is pleased to announce its NES100 dose range finding toxicity study will be presented at The Society of Toxicology (SOT) 64^th annual meeting and Tox Expo taking place March 16-20^th in Orlando, FL. This is a premier gathering of scientists and professionals in the field of toxicology to advance science in this area.

Virpax was previously granted an extension of its 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. This collaboration is for the continued development of Virpax’s product candidate, NES100, an intranasal peptide, for the management of acute and chronic non-cancer pain.

NES100 is an enkephalin drug product based on a type of nanotechnology delivery approach. Enkephalin is a naturally occurring (endogenous) peptide that is not easily administered in its original form. We believe that the nanotechnology may enable and enhance the delivery of this metabolically labile peptide drug into the brain. Unlike other drug formulations, we have the ability to deliver NES100 directly to the brain via the olfactory neurons in the upper nasal cavity bypassing the blood brain barrier which has proven to be a clinical challenge with other strategies. NES100 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 (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. NES100 has demonstrated analgesic potential in animal models without the development of opioid tolerance, withdrawal, respiratory depression, euphoria, or addiction associated with use of opioids.

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.

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 Contact:

info@virpaxpharma.com

Source: Virpax Pharmaceuticals, Inc.

FAQ

What is the mechanism of action for Virpax's NES100 (VRPX) pain management drug?

NES100 uses nanotechnology to deliver enkephalin through the nose directly to the brain via olfactory neurons, bypassing the blood-brain barrier to suppress pain by binding to delta opioid receptors.

What advantages does VRPX's NES100 show over traditional opioids in animal studies?

Animal studies show NES100 provides pain relief without developing opioid tolerance, withdrawal symptoms, respiratory depression, euphoria, or addiction risks.

When will Virpax (VRPX) present its NES100 toxicity study findings?

The NES100 toxicity study will be presented at The Society of Toxicology 64th annual meeting, March 16-20th in Orlando, FL.

What is the delivery system used in VRPX's NES100 pain management treatment?

NES100 uses a preassembled device and cartridge with Molecular Envelope Technology (MET) to propel enkephalin formulation through the nose to the brain.