Virpax Pharmaceuticals Engages Dr. Kenneth W. Sommerville and Dr. Lawrence Fried to Assist in Development of NobrXiol™ (formerly VRP324)

Rhea-AI Summary

Virpax Pharmaceuticals (NASDAQ: VRPX) announced the engagement of Dr. Kenneth W. Sommerville and Dr. Lawrence Fried to advance the development of NobrXiol, a cannabidiol product aimed at managing epilepsy. Their expertise includes advising on trial design and regulatory pathways. NobrXiol employs Nanomerics' Molecular Envelope Technology for nasal delivery to enhance efficacy in reaching the brain. This partnership is expected to bolster patient recruitment and advocacy efforts.

Positive

• Engaged leading physicians with extensive experience in childhood epilepsy.
• NobrXiol employs advanced delivery technology to potentially enhance efficacy.
• Collaboration expected to improve regulatory pathways and trial design.

Negative

• None.

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 engaged two leading physicians experienced in childhood epilepsy, Dr. Kenneth W. Sommerville and Dr. Lawrence Fried, to support the overall development plan for NobrXiol. Their involvement with this program is expected to include advising on trial design, regulatory pathway development and patient recruitment. Additionally, it is anticipated that they will support Virpax with patient advocacy groups and grant applications.

NobrXiol is the Company’s product candidate for the delivery of cannabidiol in the management of epilepsy in children and adults that 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.

Dr. Kenneth W. Sommerville is a board-certified neurologist with over 30 years of experience working with major multinational pharmaceutical companies enabling approvals for numerous drugs with both the FDA and the EMEA. He is a recognized authority in drug development with an expertise in anti-epileptic drugs, pain, and abuse-deterrent opioids. Dr. Sommerville was in charge of Phases II and III of the U.S. epilepsy trials for cannabidiol. The lead cannabinoid, CBD (Epidiolex®), received FDA approval in June of 2018.

Dr. Lawrence Fried is an experienced clinical leader in epilepsy and neurology and a practicing epileptologist. He currently serves as an Attending Physician in the Pediatric Regional Epilepsy Program at the Children’s Hospital of Philadelphia, as well as an Assistant Professor of Clinical Neurology at the University of Pennsylvania and is a Corporate Advisory Committee member of the American Epilepsy Society. Following medical school, he completed five years in residency positions in pediatrics and pediatric neurology, followed by a fellowship in epilepsy and pediatric neurology and has published extensively in those fields.

“These two outstanding physicians bring a wealth of knowledge and experience in childhood epilepsy to Virpax,” commented Dr. Sheila A. Mathias, Chief Scientific Officer for Virpax. “We expect that Dr. Sommerville, with his direct experience in U.S. epilepsy trials and the approval of Epidiolex, will be instrumental in advising on our trial design and regulatory pathway. Additionally, we anticipate that Dr. Fried, as a practicing epileptologist, will provide us with invaluable insight into our proposed patient population and important advocacy groups as well as assist us in pursuing appropriate grant funding. We welcome them both to Virpax and look forward to their contributions.”

About NobrXiol™

Virpax has acquired the exclusive worldwide rights from Nanomerics to use Nanomerics’ Molecular Envelope Technology (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 specific types of rare epilepsy syndromes in children 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/20230104005063/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 recent development has Virpax Pharmaceuticals (VRPX) achieved?

Virpax Pharmaceuticals announced the engagement of two leading physicians to support the development of NobrXiol, a cannabidiol product for epilepsy.

Who are the physicians engaged by Virpax Pharmaceuticals for NobrXiol?

Dr. Kenneth W. Sommerville and Dr. Lawrence Fried have been engaged by Virpax Pharmaceuticals to assist with NobrXiol's development.

What is NobrXiol and its significance in the market?

NobrXiol is a cannabidiol product candidate aimed at managing epilepsy in children and adults, utilizing innovative delivery technology to enhance brain transport.

How does NobrXiol improve upon existing epilepsy treatments?

NobrXiol's use of nasal delivery technology aims to bypass the digestive system, potentially reducing side effects associated with current treatments.

What role do the engaged physicians play in the development of NobrXiol?

They will advise on trial design, regulatory pathways, patient recruitment, and collaboration with patient advocacy groups.