Virpax Pharmaceuticals (NSDQ:VRPX) today reported positive results from a study of its Epoladerm treatment for chronic pain management.
Berwyn, Pennsylvania-based Virpax designed Epoladerm, one of its lead investigational products, for managing pain associated with osteoarthritis of the knee.
According to a news release, the company reported positive results following the completion of a toxicology and pharmacokinetic study designed to support clinical trials with Epoladerm.
Charles River Laboratories, having been engaged by Virpax to perform FDA-required pre-clinical studies, completed a single-dose pharmacokinetic study of dermal administration of Epoladerm, delivered through a pre-filled device as a topical spray film.
Virpax’s proprietary technology acts as an aerosol canister for the application of the spray film to the knee. The company touts the resulting film as thinner than a standard liquid bandage, with clear coating upon application to the knee, while it dries fast.
Charles River Laboratories’ study had Epoladerm administrated in minipigs as part of the investigational new drug (IND) application-enabling trials, with delivery well-tolerated in all minipigs. There were no treatment-related clinical observations, changes in body weight or dermal irritation.
All Epoladerm-treated animals had plasma levels of Epoladerm confirming transdermal absorption, with the maximum plasma concentration reached at four hours post-dose, while plasma Epoladerm remained at 24 hours post-dose for all animals.
Virpax said it expects the data to strengthen its IND filing with the FDA in advance of its anticipated commencement of first-in-human clinical trials.
“This is an important step in the development of Epoladerm and further prepares us for expected clinical trials,” Virpax Chairman & CEO Anthony P. Mack said. “The results of this study underscore the safety of our spray film technology.”
