Virpax Reports Positive Results in Human Study for its Molecular Envelope Technology

Rhea-AI Summary

Virpax Pharmaceuticals (VRPX) announced positive results from Nanomerics' human study of Molecular Envelope Technology (MET), showing no moderate to severe adverse events. MET is a key component in Virpax's two main products: Envelta and NobrXiol.

The SUNLIGHT trial, a Phase I study conducted with 10 volunteers over 28 days, tested MET-powered eye drops with twice-daily administration. The trial demonstrated safety and tolerability with no significant adverse effects or changes in safety assessments.

Envelta, developed in partnership with the National Center for Advancing Translational Sciences, uses MET to deliver enkephalin for pain management without opioid tolerance risks. NobrXiol utilizes MET to deliver cannabidiol across the blood-brain barrier for epilepsy management in children and adults.

Positive

• Phase I trial demonstrated safety with no moderate/severe adverse events
• 100% participant retention rate in clinical trial
• Successful proof of MET delivery system safety
• Pre-IND guidance received from FDA for NobrXiol

Negative

• Early-stage Phase I trial only - efficacy not yet demonstrated
• Small study size of only 10 volunteers

Insights

Financial Analyst

Nanomerics' successful completion of a human safety study for Molecular Envelope Technology (MET) represents a significant de-risking event for Virpax Pharmaceuticals' development pipeline. The absence of moderate to severe adverse events in this 28-day administration study provides the first human safety validation for the delivery technology underpinning Virpax's two lead candidates.

This safety milestone is particularly valuable for Virpax's development strategy for two reasons:

• For Envelta (pain management): The safety data supports Virpax's non-addictive pain management approach, potentially offering an alternative in the opioid crisis landscape
• For NobrXiol (epilepsy): The demonstration that MET can safely deliver compounds across the blood-brain barrier strengthens the technical foundation for this cannabidiol-based therapy

For a micro-cap company ($4.5 million market capitalization), this external validation of their technology platform could prove pivotal for future financing rounds or partnership discussions. While Virpax didn't bear the direct costs of this trial, they benefit from the risk reduction without the associated R&D expenditure.

However, several critical hurdles remain before commercial viability. This study only addressed safety of the delivery technology, not efficacy of Virpax's specific formulations. Both Envelta and NobrXiol will require their own clinical trials demonstrating both safety and efficacy for their targeted indications.

The NIH collaboration for Envelta development suggests potential for non-dilutive funding pathways, which could extend Virpax's cash runway. For investors, this news reduces one element of technical risk, though considerable development, regulatory, and commercialization challenges remain for this early-stage pharmaceutical company.

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, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250227128970/en/

Investor:

info@virpaxpharma.com

Source: Virpax Pharmaceuticals, Inc.

FAQ

What were the key findings of VRPX's MET human safety study?

The Phase I SUNLIGHT trial showed no moderate to severe adverse events, with all 10 volunteers completing the 28-day study without dropouts. The MET eye drops were well-tolerated with no significant safety concerns.

How does Virpax's Envelta (NES100) utilize MET technology?

Envelta uses MET to deliver enkephalin to the brain, targeting delta opioid receptors for pain suppression without developing opioid tolerance or reward-seeking behavior.

What is the purpose of VRPX's NobrXiol product?

NobrXiol uses MET to deliver cannabidiol through the nose to the brain via the olfactory nerve for managing epilepsy in children and adults.

When was the VRPX SUNLIGHT trial conducted and what did it involve?

The trial was conducted from December 2024 to January 2025, involving twice-daily administration of MET eye drops and OC134 eye drops to healthy volunteers.