Preparing Investigational New Drug Application for Submission Upon Completion of Canadian Clinical Study
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 disorders and anti-viral indications, completed all FDA required pre-clinical studies for Epoladerm™, Virpax’s investigational pre-filled topical spray analgesic product to manage chronic pain associated with osteoarthritis (OA) of the knee. The key Investigational New Drug Application (IND)-enabling studies completed included dermal toxicity, sensitization, irritation, phototoxicity and PK characteristics.
Virpax is drafting FDA IND submission documents for Epoladerm that will include these pre-clinical studies. Additionally, in January 2022, Virpax announced a clinical trial agreement with Altasciences Company, Inc., to complete a first-in-human pilot study investigating Epoladerm for pain associated with OA of the knee. The pilot study will take place in Canada under a Clinical Trial Application (CTA) filing with enrollment of the first patient anticipated in 2022. Virpax plans to submit the results of the pilot study as part of its IND application.
“Physicians commonly encounter patients with pain from osteoarthritis (OA). The American College of Radiology guidelines on OA, as well as clinical practice guidelines from the American Academy of Family Physicians and the American College of Physicians recommend topical non-steroidal anti-inflammatory drugs (NSAIDs) as first-line therapy before recommending oral NSAIDs,” stated Jeff Gudin, MD, Professor of Anesthesiology and Executive Vice President and Chief Medical Officer of Virpax.
“Our internal research and development team, along with an extensive network of partners, has progressed Epoladerm through the IND-enabling studies. We believe our clinical studies will demonstrate that Epoladerm, which utilizes our unique spray film technology, will be a more effective and easier-to-use treatment for OA of the knee than what is currently available. We anticipate rapid progress toward the completion of the clinical studies,” stated Anthony P. Mack, Chairman and Chief Executive Officer of Virpax.
Virpax Pharmaceuticals is developing Epoladerm™ (diclofenac epolamine), an investigational analgesic supplied in a pre-filled device for administration as a topical spray film to manage chronic pain associated with osteoarthritis of the knee. The Company’s proprietary technology is intended to provide a convenient aerosol canister for application of the spray film to the knee. The resulting film is intended to be thinner than a standard liquid bandage, visibly clear and fast drying. The spray formulation is intended to avoid the inconvenient and messy application of creams or gels to the knee.
About Virpax Pharmaceuticals
Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval of its three patented drug delivery platforms. Epoladerm™ is a topical diclofenac spray film formulation being developed to manage osteoarthritis pain. Probudur™ is a single injection long-acting liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal Molecular-Envelope Technology (MET) enkephalin formulation being developed for the management cancer and non-cancer pain, as well as post-traumatic stress disorder (PTSD) under the name PES200. MET technology is also used in AnQlar™, a candidate to inhibit viral replication caused by influenza or SARS-CoV-2. Virpax recently acquired global rights to VRP324, a product candidate for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of epilepsy in children (a rare pediatric disease) and adults. For more information, please visit www.virpaxpharma.com.
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Christopher M. Chipman, CPA
Chief Financial Officer
Affinity Growth Advisors
Virpax Pharmaceuticals, Inc.
1055 Westlakes Drive, Suite 300
Berwyn, PA 19312
Affinity Growth Advisors
Virpax Pharmaceuticals, Inc.