BERWYN, Pa. – 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 the initial results from the pilot study for Probudur™ performed by the U.S. Army Institute of Surgical Research (USAISR) under an existing Cooperative Research and Development Agreement (CRADA). The USAISR is the U.S. Department of Defense’s premier research organization for developing solutions for trauma and critical care challenges in combat casualties.
This study was designed to determine if Probudur reduces pain behaviors in a rat model of incisional pain. Two concentrations of Probudur were injected into the tissue around the incision site as well as a saline solution for the control group. Both doses of Probudur showed reduction in incision-induced pain behaviors.
“While the data from these studies will be further analyzed, these positive results are consistent with what we at Virpax have previously observed. We are encouraged by these initial findings and expect that the next step by the USAISR would be a full powered study comparing Probudur with free bupivacaine and EXPAREL®,” commented Gerald W. Bruce, CEO of Virpax Pharmaceuticals.
Probudur is being developed by Virpax to significantly reduce or eliminate the need for opioids after surgery or trauma in approved indications. In pre-clinical trials, Probudur has shown long duration pain control for at least 96 hours.
“All of our RX products have CRADAs associated with them, similar to the USAISR one recently highlighted in a Forbes.com article. Virpax has developed a core competency in identifying, applying for, and winning government grants which are an essential part of our non-dilutive funding strategy. We are continuing to apply for additional grants to help fund our upcoming clinical trials. In the interim, we are moving ahead with our remaining confirmational studies for Probudur and Envelta™ and are still on target to file Investigational New Drug (IND) Applications in the second half of this year,” concluded Mr. Bruce.
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 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). 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.
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and Private Securities Litigation Reform Act, as amended, including those described below. 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 the next step by the USAISR being a full powered study comparing Probudur with free bupivacaine and EXPAREL, developing Probudur to significantly reduce or eliminate the need for opioids after surgery or trauma in approved indications, continuing to apply for additional grants to help fund upcoming clinical trials, moving ahead with remaining confirmational studies for Probudur and Envelta™ and still being on target to file Investigational New Drug (IND) Applications in the second half of this year. These statements relate to future events 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 Company’s ability to obtain additional grants to help fund upcoming clinical trials; the Company’s ability to move ahead with remaining confirmational studies for Probudur and Envelta™ as planned; 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 Company’s ability 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 has filed 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.
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