Virpax Completes All FDA-Required Pre-Clinical Studies for Epoladerm™

Rhea-AI Summary

Virpax Pharmaceuticals has completed all FDA-required pre-clinical studies for its investigational topical analgesic, Epoladerm™, aimed at managing chronic knee pain due to osteoarthritis. The studies encompassed dermal toxicity and phototoxicity, among others. Virpax is preparing to submit its Investigational New Drug Application (IND) including these results. A clinical trial agreement with Altasciences is in place for a first-in-human pilot study in Canada, with patient enrollment expected in 2022.

Management expresses confidence that Epoladerm will be a more effective treatment option for osteoarthritis pain.

Positive

• Completed all FDA-required pre-clinical studies for Epoladerm.
• Preparing IND submission with completed study results.
• Agreement with Altasciences for human clinical trials in Canada.

Negative

• Patient enrollment for the clinical trial anticipated to start in 2022, indicating possible delays.

Preparing Investigational New Drug Application for Submission Upon Completion of Canadian Clinical Study

BERWYN, Pa.--(BUSINESS WIRE)-- 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.

About Epoladerm™

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.

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 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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220322005148/en/

Christopher M. Chipman, CPA

Chief Financial Officer

cchipman@virpaxpharma.com

610-727-4597

Investor Relations:

Betsy Brod

Affinity Growth Advisors

betsy.brod@affinitygrowth.com

212-661-2231

Media:

Laura Radocaj

DGI

212-825-3210

Source: Virpax® Pharmaceuticals, Inc.

FAQ

What is Epoladerm and its purpose?

Epoladerm is an investigational topical spray analgesic designed to manage chronic pain associated with osteoarthritis of the knee.

When will the clinical trial for Epoladerm begin?

Patient enrollment for the clinical trial is anticipated to start in 2022.

What studies has Virpax completed for Epoladerm?

Virpax has completed all FDA-required pre-clinical studies, including dermal toxicity and phototoxicity.

How does Epoladerm differ from current pain management treatments?

Epoladerm utilizes unique spray film technology, aimed at providing a more effective and convenient application compared to traditional creams or gels.

What is the significance of the IND submission for Epoladerm?

The IND submission will include the results of the pre-clinical studies, which is a critical step toward obtaining FDA approval for clinical use.

What potential impacts does Epoladerm have on the market?

If approved, Epoladerm could offer an innovative non-addictive treatment option for patients suffering from osteoarthritis pain, thereby enhancing pain management alternatives.