Virpax Successfully Completes Initial Preclinical Studies for VRP324

By: Virpax Pharmaceuticals, Inc. via Business Wire

April 26, 2022 at 09:00 AM EDT

-Nasal CBD Candidate to Manage Seizures Associated with Epilepsy in Children and Adults-

Virpax^® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing non-addictive product candidates for pain management, CNS disorders and anti-viral indications, reported preclinical pharmacokinetics (PK) results for VRP324 (MET-CBD), a nose-to-brain delivery platform for CBD for the management of seizures in children and adults. In this preclinical PK study, VRP324 was able to deliver cannabidiol (CBD) to the brain after nasal administration in a rodent model. Nasal delivery of VRP324 provided high concentrations of CBD in the brain and the preclinical studies confirm that there were higher levels of CBD in the brain versus the plasma.

Virpax believes that VRP324 may achieve higher efficiency via the nasal route compared to the oral CBD product on the market since peripheral exposure via plasma may be reduced by the nose-to-brain delivery. Evidence suggests that compared to the commercialized oral-dosed CBD, the nose-to-brain CBD formulation may have negligible liver first-pass metabolism, thereby avoiding drug to drug interactions and potentially producing fewer side effects. By avoiding the first pass effect, intranasal VRP324 may also eliminate enzymatic degradation.

“The results from this preclinical PK study met our expectations. We are encouraged that our molecular envelope technology (MET) may offer a more effective and efficient delivery method than the approved oral formulation, especially for children who suffer from seizure disorders. As previously stated, we plan to immediately proceed with preparing a pre-IND application briefing document for the U.S. Food and Drug Administration’s review,” commented Anthony P. Mack, Chairman and Chief Executive Officer of Virpax.

VRP324 uses a preassembled device and cartridge to propel the MET-CBD powder formulation into the nose via the olfactory nerve/bulb. This product candidate has been formulated to potentially treat seizures associated with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome and Dravet syndrome in patients one year of age and older. Lennox-Gastaut syndrome and Dravet syndrome are rare central nervous system diseases considered serious epileptic encephalopathies that cause different types of epileptic seizures, and cognitive and behavioral changes. These syndromes have historically been resistant to treatment.

“We are pleased to have generated successful preclinical PK data in support of the exclusive license for VRP324, previously granted to Virpax by Nanomerics Ltd. and we look forward to working with Virpax to bring this much needed treatment to epilepsy patients,” said Professor Ijeoma F. Uchegbu, Chief Scientific Officer of Nanomerics Ltd.

About VRP324

VRP324 is a drug product candidate based on nanotechnology enabling the delivery of CBD into the brain via intranasal delivery for the management of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older, as well as patients one year of age and older who experience seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome. VRP324 is manufactured using high pressure homogenization and spray drying. In animal studies, the MET nanoparticles are well-tolerated via the nasal route at the dose administered.

About Nanomerics

Nanomerics Ltd is a specialty pharmaceutical company based in London, United Kingdom. Nanomerics was spun out of University College London and was founded to commercialize 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. Nanomerics’ MET won first prize in the UK’s Royal Society of Chemistry Emerging Technologies competition. The founding scientists Professor 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. For more information, please visit www.nanomerics.com.

About Virpax Pharmaceuticals

Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval of its three patented drug delivery platforms. Epoladerm™ is a topical diclofenac spray film formulation being developed to manage osteoarthritis pain. Probudur™ is a single injection long-acting liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal Molecular-Envelope Technology (MET) enkephalin formulation being developed for the management post cancer pain and non-cancer pain, as well as post-traumatic stress disorder (PTSD) under the name PES200. MET technology is also used in AnQlar™, a candidate to inhibit viral replication caused by influenza or SARS-CoV-2. Virpax recently acquired global rights to VRP324, a product candidate for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of rare pediatric epilepsy. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220426005104/en/

Contacts

Christopher M. Chipman, CPA

Chief Financial Officer

cchipman@virpaxpharma.com

610-727-4597

Investor Relations:

Betsy Brod

Affinity Growth Advisors

betsy.brod@affinitygrowth.com

212-661-2231

Media:

Laura Radocaj

DGI

212-825-3210

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Virpax Successfully Completes Initial Preclinical Studies for VRP324

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