Virpax Pharmaceuticals Announces that Envelta™ Remains on Track for Trial in Humans Following FDA Review

By: Virpax Pharmaceuticals via Business Wire

October 31, 2023 at 08:58 AM EDT

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 anti-viral barrier indications, today announced that it expects to submit an Investigational New Drug Application (IND) for Envelta in mid-2024 following review of comments made by the US Food and Drug Administration on the Company’s Pre-IND submission. If successful, that would allow clinical trials to begin by the middle of 2024.

Envelta (MET-LENK) is the Company’s non-addictive pain product candidate for acute and chronic pain that is being funded under an in-kind grant from the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH). Envelta utilizes a novel and patented intranasal drug delivery system, Molecular Envelope Technology (MET) to bypass the blood-brain barrier. The MET was developed by Nanomerics, Ltd., a UK-based nanotechnology research and development company that has licensed its MET-LENK to Virpax. The nose-to-brain MET platform protects molecules from biodegrading and enhances the bioavailability of product candidates on its transport to the brain.

The initial Envelta dose ranging studies in rats and dogs have been completed. The 14-day rat dose range finding study (DRF) showed no treatment related clinical signs or mortality. In addition, there were no related findings in hematology, coagulation, and serum chemistry data. The 14-day DRF study in dogs also showed no treatment related mortality or findings in body temperature, body weight, food consumption, and ophthalmic exam. From an efficacy perspective, a dose-response with intranasal MET-LENK was noted in a Complete Freund’s Adjuvant (CFA) anti-hyperalgesia model versus an intranasal placebo and subcutaneous morphine. Administration of the high dose MET-LENK (30 mg/kg) significantly decreased hypersensitivity in treated animals compared to CFA control.

“There is a significant unmet need for effective analgesics with limited or no abuse potential. Our research on Envelta suggests that there is a clear efficacy signal with minimal adverse effects noted in animals in all of our head-to-head comparisons to morphine. Using our novel MET, leucine-enkephalin can be delivered to the brain via an intranasal formulation of nanoparticles which helps to protect from biodegradation. If human data confirms analgesic benefit without drug tolerance or drug-seeking behavior, this formulation may represent a potential broad-spectrum molecule to treat severe pain and CNS disorders,” stated Anthony P. Mack, Chairman and CEO of Virpax. “We are grateful to the FDA for the thorough and clear direction that was provided to us in our pre-IND meeting. With the ongoing support of our NIH colleagues, we expect to continue advancing Envelta through preclinical development leading up to first in human trials in 2024.”

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 has competitive cooperative research and development agreements (CRADAs) for all three of its prescription drug candidates, two with the National Institutes of Health (NIH) and one with the Department of Defense (DOD). Novvae™ Pharmaceuticals, a wholly-owned subsidiary of Virpax, is developing over-the-counter (OTC) products using innovative metered-dose drug delivery platforms. Novvae is seeking approval of AnQlar which is being developed to inhibit viral replication caused by influenza or SARS-CoV-2.For more information, please visit virpaxpharma.com and follow us on Twitter, LinkedIn and YouTube.

Forward-Looking Statements

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 and include statements regarding submitting an Investigational New Drug Application for Envelta in mid-2024, beginning clinical trials by the middle of 2024, research on Envelta suggesting that there is a clear efficacy signal with minimal adverse effects noted in animals in head-to-head comparisons to morphine, human data confirming analgesic benefit without drug tolerance or drug-seeking behavior, the formulation representing a potential broad-spectrum molecule to treat severe pain and CNS disorders and continuing to advance Envelta through preclinical development. These statements relate to future events or the Company’s financial performance and involve known and unknown risks, uncertainties, and other factors, including the impact of any damages or remedies awarded in the additional proceedings of the lawsuit filed in the Delaware Chancery Court against the Company; the Company’s ability to successfully begin trials when expected and 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 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/20231031904726/en/

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Investor Relations Contact:

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Affinity Growth Advisors

Betsy.brod@affinitygrowth.com

(917) 923-8541

Media Contact:

Robert Cavosi

RooneyPartners

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(646) 638-9891

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Virpax Pharmaceuticals Announces that Envelta™ Remains on Track for Trial in Humans Following FDA Review

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