Virpax Pharmaceuticals Reports on FDA Pre-IND Response for NobrXiol™ (formerly VRP324)

Rhea-AI Summary

Virpax Pharmaceuticals (NASDAQ: VRPX) has received guidance from the FDA on the pre-Investigational New Drug (PIND) application for its cannabidiol product candidate, NobrXiol, aimed at managing epilepsy in children and adults. Utilizing the Nanomerics Molecular Envelope Technology, NobrXiol aims to deliver cannabidiol directly to the brain through the nasal route. The FDA's feedback paves the way for IND-enabling studies, helping Virpax move forward with regulatory planning and potential clinical trials.

Positive

• Received FDA pre-IND guidance for NobrXiol, expediting the regulatory process.
• NobrXiol's delivery system may offer significant advantages over existing CBD treatments.

Negative

• None.

--VRPX Intranasal Cannabidiol Product Candidate for Management of Epilepsy in Children and Adults--

BERWYN, Pa.--(BUSINESS WIRE)-- Virpax^® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and viral barrier indications, today announced that it has received pre-Investigational New Drug (PIND) application guidance from the U.S. Food and Drug Administration (FDA) for NobrXiol™, the Company’s product candidate for the delivery of cannabidiol in the management of epilepsy in children and adults. NobrXiol utilizes the Nanomerics Molecular Envelope Technology (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 main purpose of a pre-IND submission is to obtain FDA guidance on the overall development plan for a new drug and to identify any need for further data prior to submitting the IND.

“Virpax now has guidance on how to proceed with the IND enabling studies and possible regulatory pathways to pursue for NobrXiol,” stated Dr. Sheila A. Mathias, Chief Scientific Officer for Virpax. “Based on the written responses from the FDA and its recommendations, we believe that we can proceed with the next steps in the process towards an IND application for this product candidate.”

“This is a significant step forward for the NobrXiol project and we are very pleased with the outcome of the pre-IND meeting with the FDA,” said Anthony P. Mack, Chairman and CEO of Virpax. “We believe this product candidate has potential benefits over existing oral CBD treatments for epilepsy including Dravet Syndrome and Lennox-Gastaut Syndrome. We believe that by using the MET delivery system there may be significant advantages for patients including fewer side effects, avoidance of drug-to-drug interaction and lower dosing of CBD required,” concluded Mr. Mack.

About NobrXiol™

Virpax has acquired the exclusive worldwide rights from Nanomerics to use Nanomerics' MET platform for the nasal delivery of cannabidiol (CBD) for the management of epilepsy in children (a rare pediatric disease) and adults. As part of this agreement, Nanomerics is developing an investigational formulation delivered via the nasal route to enhance CBD transport to the brain which could potentially eliminate any drug interaction issues and bypass the digestive system, possibly eliminating many of the side effects associated with the product currently in use on the market. Nanomerics demonstrated the ability of its platform technology to deliver CBD directly to the brain in an animal model.

About Virpax Pharmaceuticals

Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies that optimize and target drug delivery. Virpax is initially seeking FDA approval of its three different patented drug delivery platforms. Epoladerm™ is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis of the knee. 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 of acute and chronic pain, including pain associated with cancer, 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 acquired global rights to NobrXiol™, a product candidate for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of epilepsy in children (a rare pediatric disease) and adults. 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 the Company’s financial performance and involve known and unknown risks, uncertainties, and other factors, including the potential impact of the COVID-19 pandemic and the potential impact of sustained social distancing efforts, on the Company’s operations, clinical development plans and timelines, including any feedback received from the FDA, 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/20221214005204/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

Source: Virpax Pharmaceuticals, Inc.

FAQ

What is NobrXiol from Virpax Pharmaceuticals?

NobrXiol is a product candidate developed by Virpax for delivering cannabidiol intranasally to manage epilepsy in children and adults.

How does NobrXiol work?

NobrXiol uses Nanomerics Molecular Envelope Technology to deliver cannabidiol directly to the brain through the nasal route, potentially reducing side effects and drug interactions.

What is the significance of the FDA's guidance for VRPX?

The FDA's guidance on the pre-IND application for NobrXiol allows Virpax to proceed with IND-enabling studies and defines the regulatory pathway for further development.

What potential benefits does NobrXiol have over existing treatments?

NobrXiol may have fewer side effects, lower dosing requirements, and a reduced chance of drug-to-drug interactions compared to current oral CBD treatments.