Virpax® Successfully Completes Preclinical Dermal Safety Studies for Epoladerm™

Rhea-AI Summary

Virpax Pharmaceuticals (NASDAQ: VRPX) announced positive results from four preclinical dermal safety studies for its investigational product, Epoladerm (diclofenac epolamine), aimed at managing osteoarthritis knee pain. Conducted by Charles River Laboratories, these studies indicated that Epoladerm was well-tolerated with no serious adverse findings, including skin irritation or sensitization. The successful outcomes support the company’s upcoming Investigational New Drug Application, paving the way for first-in-human trials.

Positive

• Epoladerm demonstrated well-tolerated results in four preclinical safety studies.
• No serious adverse findings or skin issues were reported during studies.
• Successful preclinical data strengthens the upcoming Investigational New Drug Application.

Negative

• None.

Well-tolerated with No Serious Adverse Findings

BERWYN, Pa.--(BUSINESS WIRE)-- Virpax^® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing product candidates for pain management, CNS disorders, and anti-viral indications, reported positive results of four preclinical dermal safety studies for Epoladerm™ (diclofenac epolamine). Epoladerm is an investigational product candidate for the management of pain associated with osteoarthritis of the knee. From these recently concluded animal studies, researchers concluded that once daily dermal administration of Epoladerm for 28 days was well-tolerated with no serious adverse findings.

The studies were performed by Charles River Laboratories, a well-known clinical research organization. The studies included a skin irritation study in rabbits; a dermal sensitization assessment in guinea pigs; and a phototoxicity assay in mouse fibroblasts. Epoladerm was well- tolerated in each of the studies and no reportable dermal irritation, dermal sensitization or phototoxicity was observed.

“These successful preclinical outcomes should further strengthen Virpax’s planned Investigational New Drug Application for Epoladerm in advance of the anticipated start of first-in-human trials,” said Anthony P. Mack, Chairman and CEO 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 of acute and chronic pain, including pain associated with cancer, as well as post-traumatic stress disorder (PTSD) under the name PES200. MET technology is also used in AnQlar™, a product candidate intended 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220118005164/en/

Christopher M. Chipman, CPA

Chief Financial Officer

cchipman@virpaxpharma.com

(610) 727-4597

Or

Investor Relations:

Betsy Brod

Affinity Growth Advisors

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(212) 661-2231

Media:

Laura Radocaj

DGI

212-825-3210

Source: Virpax Pharmaceuticals, Inc.

FAQ

What are the results of the recent studies for Epoladerm by Virpax Pharmaceuticals?

The recent studies indicated that Epoladerm was well-tolerated with no serious adverse findings and no reports of skin irritation or sensitization.

What is Epoladerm and what is it used for?

Epoladerm is an investigational product for managing pain associated with osteoarthritis of the knee, delivered as a topical spray film.

What company conducted the preclinical studies for Epoladerm?

The preclinical studies for Epoladerm were conducted by Charles River Laboratories.

What is the significance of the studies for Virpax Pharmaceuticals' future plans?

The positive outcomes from the studies bolster Virpax's planned Investigational New Drug Application, facilitating the start of first-in-human trials.