Virpax Announces Positive Preclinical Toxicology Results in Support of Molecular Envelope Technology (MET)

Rhea-AI Summary

Virpax Pharmaceuticals (NASDAQ: VRPX) has completed FDA-required preclinical toxicology studies for its Molecular Envelope Technology (MET), which enhances drug delivery for its pain management and epilepsy product candidates. This study aims to evaluate the safety of MET in preparation for IND submissions. Developed by Nanomerics Ltd., this technology is crucial for multiple drug candidates including AnQlar™ and Envelta™. Dr. Jeffrey Murray, a former FDA expert, is advising the company on clinical trial design, emphasizing MET's potential to improve drug administration while reducing interactions and dosage needs.

Positive

• Completion of FDA-required preclinical toxicology studies for MET enhances prospects for IND submissions.
• Engagement of Dr. Jeffrey Murray, an FDA expert, strengthens clinical trial design capabilities.
• MET technology could improve drug delivery efficiency and reduce drug interactions.

Negative

• No current financial metrics or market data provided to assess immediate impact.

-- MET Platform Nose-to-Brain Delivery Serves as Foundation for Multiple Virpax Drug Candidates --

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, announced today that the Company has completed FDA required preclinical toxicology studies for its licensed Molecular Envelope Technology (MET). MET enhances the delivery of Virpax’s non-addictive pain product and its epilepsy product candidate. MET is also utilized in the Company’s viral barrier product candidate. These preclinical toxicology studies were performed to evaluate the safety of the MET platform and to support the IND submission of each product candidate.

The Molecular Envelope Technology was developed by Nanomerics Ltd., a UK-based nanotechnology research and development company. Nanomerics has licensed its technology to Virpax, which is utilizing the nose-to-brain MET platform to enhance drug delivery for certain of its product candidates.

“We are working with a variety of CROs and scientific and pharmaceutical industry leaders to help us evaluate the safety of the MET platform, which underpins a number of our current drug development efforts such as AnQlar^™ which is our viral barrier product candidate. We anticipate that MET will also be a part of our plans for current and future drug development programs. We have engaged Dr. Jeffrey Murray, a leading expert in infectious diseases who spent almost 30 years of his career with the FDA, including as the Deputy Division Director for the Division of Antivirals, Center for Drug Evaluation and Research. Dr. Murray has published many articles related to antivirals and served as a reviewer for the New England Journal of Medicine while at FDA. He has been a valuable contributor to us in the antiviral area in addition to clinical trial design,” commented Dr. Sheila A. Mathias, Chief Scientific Officer for Virpax.

“We are using the MET platform for Envelta^™, AnQlar^™ and NobrXiol^™ and expect to use it in other future programs. This patented technology is designed to deliver drug molecules to the brain while reducing degradation during their intranasal transport past the blood-brain barrier. We believe that this drug delivery technology will lessen drug-to-drug interaction and reduce drug dosing. We will be moving these programs to the clinic and appreciate the support of the Virpax team as well as the leading physicians and researchers who are working side by side with us,” concluded Anthony P. Mack, Chairman and CEO of Virpax.

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 two other product candidates. PES200 is a product candidate being developed to manage post-traumatic stress disorder (PTSD) and NobrXiol™ is a product candidate being developed for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of rare pediatric epilepsy. Virpax recently acquired global rights to NobrXiol. Virpax is also seeking approval of 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 virpaxpharma.com and follow us on Twitter, LinkedIn and YouTube.

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 Company’s ability to successfully complete research and further development and commercialization of Company drug candidates in current or future indications; the uncertainties inherent in clinical testing; the Company’s ability to manage and successfully complete clinical trials and the research and development efforts for multiple product candidates at varying stages of development; the effects of the outbreak of COVID-19 on the Company’s business and results of operations; the timing, cost and uncertainty of obtaining regulatory approvals for the Company’s product candidates; the Company’s ability to protect its intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's product candidates; the Company’s ability to continue to obtain capital to meet its long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete clinical trials that the Company plans to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q that the Company files 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/20230213005043/en/

Betsy Brod

Affinity Growth Advisors

betsy.brod@affinitygrowth.com

212-661-2231

Source: Virpax Pharmaceuticals

FAQ

What is the Molecular Envelope Technology developed by Virpax Pharmaceuticals (VRPX)?

Molecular Envelope Technology (MET) is a patented platform designed to enhance drug delivery, particularly for Virpax's pain management and epilepsy product candidates.

What is the significance of the recent FDA toxicology studies for Virpax (VRPX)?

The completion of FDA-required preclinical toxicology studies for MET is crucial for supporting the IND submissions of several drug candidates.

Who is advising Virpax Pharmaceuticals on clinical trial design?

Dr. Jeffrey Murray, a former FDA expert, is advising Virpax on clinical trial design, particularly related to antiviral studies.

Which product candidates are utilizing the Molecular Envelope Technology by Virpax (VRPX)?

Product candidates using MET include AnQlar™ (viral barrier) and Envelta™ (pain management), among others.