Virpax to Initiate Investigational New Drug (IND) Enabling Studies for Probudur(TM) for Postoperative Pain
Virpax Pharmaceuticals (NASDAQ:VRPX) announced the initiation of preclinical studies for Probudur, a long-acting injectable local anesthetic utilizing liposomal technology. Conducted in partnership with Charles River Laboratories, the studies include seven animal trials focused on dosage and toxicity as part of the FDA's Investigational New Drug Application requirements. The FDA has suggested pursuing a 505(b)(2) NDA for Probudur, with the potential to advance to Phase 2A clinical trials upon completion. Early animal studies indicate Probudur may offer significantly extended analgesic activity compared to existing products.
- Initiation of preclinical studies for Probudur, enhancing product pipeline.
- FDA's indication to pursue 505(b)(2) accelerated NDA for Probudur.
- Early studies show Probudur provides analgesic activity lasting up to 96 hours, exceeding market competitors.
- None.
BERWYN, PA / ACCESSWIRE / March 22, 2021 / Virpax® Pharmaceuticals, Inc. ("Virpax" or the "Company") (NASDAQ:VRPX), today announced that preclinical studies of Probudur™, a proprietary patented injectable, long-acting "local anesthetic" Liposomal (Hydro) Gel Technology for postoperative pain management, have been initiated under an agreement with Charles River Laboratories. Under the terms of the agreement, Charles River Laboratories will perform seven preclinical animal studies including method, dosage, and toxicity as part of the required U.S. Food and Drug Administration ("FDA") enabling trials for an Investigational New Drug Application ("IND") for Probudur™.
Anthony Mack, Chairman & Chief Executive Officer of Virpax stated, "We now have three product candidates in preclinical IND enabling studies. As anticipated, our pipeline is moving forward and we are confident that we will be able to engage in our first-in-human trials in the near future."
About Probudur ™
Probudur™ is a drug product candidate based on a unique liposomal delivery system utilizing large multivesicular vesicles ("LMVVs") encapsulating a high dose of the local anesthetic bupivacaine. These drugloaded liposomes are composed of lecithin and cholesterol which are generally recognized as safe by the FDA. These LMVVs are embedded in hydrogel beads to form a Lipogel. The system delivers a local anesthetic/analgesic medicine from the Lipogel. Early non-clinical animal studies produced data which suggests that Probudur™ may be able to provide improved onset, duration and peak performance properties as compared to a similar product on the market. Data from these animal studies demonstrated that after treatment with Probudur™, statistically significant analgesic activity (measured as threshold pressure at the withdrawal of the animal's treated extremity) was observed in comparison to a control (vehicle), for as long as 96 hours post-treatment, which is 24 hours longer than the leading product on the market.
Effective analgesia enhances recovery and reduces postoperative morbidity. Depot formulations of local anesthetics remain at the site of injection and release the drug slowly over time. Probudur™ demonstrated peak analgesia at 6 hours, a 96-hour duration, and persistent analgesia over 96 hours in a pig wound model. Probudur™ showed tolerability and safety in multiple animal models.
As a result of the Pre-Investigational New Drug ("Pre-IND") review, the U.S. Food and Drug Administration ("FDA") has indicated that it is reasonable for the Company to pursue a 505(b)(2) accelerated New Drug Application ("NDA"). Once the preclinical IND enabling studies are completed, Probudur™ may advance directly to the Phase 2A clinical trials.
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 using its three patented drug delivery platforms. Epoladerm™ is a topical diclofenac metered-dose spray film formulation being developed to manage acute musculoskeletal pain and osteoarthritis. Probudur™ is a single injection liposomal bupivacaine formulation being developed to manage postoperative pain. 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 its PES200 product candidate to manage post-traumatic stress disorder (PTSD) and its MMS019 product candidate to inhibit viral replication caused by influenza or SARS-CoV-2. 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 preclinical and 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 our financial performance and involve known and unknown risks, uncertainties, and other factors, including the potential impact of the recent COVID-19 pandemic and the potential impact of sustained social distancing efforts, on the Company's operations, clinical development plans and timelines, 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.
Contact:
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
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