Altasciences Chosen by Virpax Pharmaceuticals, Inc. to Conduct First-in-Human Study of Epoladerm™ for Chronic Pain Associated with Osteoarthritis of the Knee

Rhea-AI Summary

Virpax Pharmaceuticals (NASDAQ: VRPX) has selected Altasciences to conduct a first-in-human study of Epoladerm™ for chronic knee pain due to osteoarthritis. This innovative treatment utilizes a pre-filled device for a convenient topical spray application. Set to begin in Q2 2022 at Altasciences’ Montreal facility, the study aims to support the FDA's 505(b)(2) approval pathway. Altasciences, experienced in clinical trials, is committed to advancing this analgesic therapy towards regulatory approval, enhancing patient care through its cutting-edge technology.

Positive

• Virpax's Epoladerm™ targets chronic knee pain, a significant market need.
• Partnership with Altasciences enhances the credibility of clinical trials.
• The study's focus on FDA's 505(b)(2) approval pathway could expedite market entry.

Negative

• None.

LAVAL, Quebec--(BUSINESS WIRE)-- Altasciences is pleased to have been chosen by Virpax® Pharmaceuticals, Inc. (“Virpax”) (NASDAQ:VRPX) to conduct a first-in-human study of Epoladerm™ (diclofenac epolamine) for chronic pain associated with osteoarthritis of the knee. This treatment is supplied in a pre-filled device for administration as a topical spray film.

The study will be conducted in Q2 2022 at Altasciences’ clinical pharmacology unit in Montreal, Canada. “We look forward to working with Altasciences to accelerate the development of this analgesic treatment and provide robust data in support of the 505(b)(2) FDA approval pathway,” stated Virpax’s Chairman & CEO, Anthony P. Mack.

Virpax’s proprietary technology provides a pre-filled canister for the therapeutic application of a clear, fast-drying spray film that is thinner than a standard liquid bandage. This technology offers convenience and eliminates the need for messy creams or gels.

Altasciences leverages decades of experience conducting first-in-human clinical trials, a vast database of study participants, and state-of-the-art bioanalytical facilities to provide expert guidance and personalized solutions. Ingrid Holmes, Altasciences’ Vice President, Global Clinical Operations, says, “We are proud to partner with Virpax to help move this important therapeutic further along the path to regulatory approval.”

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single service or a synchronized approach to CRO and CDMO services, from lead candidate selection to clinical proof of concept, and beyond.

More information on Virpax® Pharmaceuticals, Inc.’s program can be found here.

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About Altasciences

Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220121005256/en/

Julie-Ann Cabana

Altasciences

+1 514 601-9763

jcabana@altasciences.com

Source: Altasciences and Virpax Pharmaceuticals, Inc.

FAQ

What is the purpose of the Epoladerm™ study by Virpax Pharmaceuticals?

The study aims to evaluate Epoladerm™ for chronic pain associated with osteoarthritis of the knee.

When will the Epoladerm™ study take place?

The study is set to begin in Q2 2022.

Who is conducting the Epoladerm™ clinical trial?

Altasciences is conducting the first-in-human study of Epoladerm™.

What is the significance of the FDA's 505(b)(2) approval pathway for Virpax?

This pathway can expedite regulatory approval for Epoladerm™, potentially allowing it to reach the market faster.

What advantages does Epoladerm™ offer over traditional treatments?

Epoladerm™ uses a clear, fast-drying spray film, providing convenience and avoiding messy creams or gels.