Virpax Pharmaceuticals Announces Preliminary Results of ProbudurTM Pilot Study with the U.S. Army Institute of Surgical Research
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Insights
The pilot study results for Probudur by Virpax Pharmaceuticals signify a potential advancement in non-opioid pain management therapies. Considering the opioid crisis, the development of alternative pain relief solutions is critical. The efficacy of Probudur in reducing pain without the need for opioids could disrupt the current pain management market, making it a significant point of interest for stakeholders. The partnership with the U.S. Army Institute of Surgical Research enhances the credibility of the study and may accelerate the regulatory approval process.
Long-duration pain control, as demonstrated in pre-clinical trials, positions Probudur as a strong candidate for post-surgical or trauma-related pain management. This could lead to a decrease in the healthcare system's reliance on opioids, potentially reducing the incidence of addiction and its associated social costs. The market potential for such a product is substantial, given the high demand for effective and safer pain management alternatives.
The strategic approach of Virpax Pharmaceuticals in securing non-dilutive funding through government grants is noteworthy. This approach mitigates the risk of shareholder dilution and conserves capital, which is particularly important for small-cap biotech firms with no revenue-generating products. The company's ability to secure these grants reflects positively on its management's acumen and operational strategy.
Investors should monitor the progress of Virpax's upcoming IND filings, as these milestones are critical in the drug development process and can significantly influence the company's stock price. The successful advancement of Probudur and Envelta™ through clinical trials could lead to substantial long-term value creation, although it is important to remember that drug development is inherently risky and subject to regulatory hurdles.
The initial results from the pilot study of Probudur, indicating a reduction in pain behaviors in a rat model, are a promising step towards addressing the unmet need for non-addictive pain management options. However, it is important to note that the transition from pre-clinical to clinical efficacy is not always linear and further analysis and full-powered studies are necessary to confirm these findings in humans.
The focus on non-addictive pain management aligns with current medical research priorities and public health initiatives. If Probudur demonstrates similar efficacy and safety in human trials, it could become a significant tool in combating the opioid epidemic. The potential for reduced healthcare costs and improved patient outcomes could make Probudur a valuable addition to the pharmaceutical market.
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.
Forward-Looking Statements
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
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Source: Virpax Pharmaceuticals, Inc.
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