BERWYN, Pa.– 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 following the completion of a toxicology and pharmacokinetic study designed to support clinical trials with Epoladerm™, one of its lead investigational product candidates for the management of pain associated with osteoarthritis of the knee.
Charles River Laboratories, a renowned CRO engaged by Virpax to perform Food and Drug Administration (FDA) required pre-clinical studies, has completed a single dose pharmacokinetic study of dermal administration of Epoladerm in minipigs as part of the required Investigational New Drug Application (“IND”) enabling trials. Single-dose transdermal delivery of Epoladerm was well-tolerated in all minipigs and no treatment-related clinical observations, changes in body weight, or dermal irritation were observed. All Epoladerm treated animals had plasma levels of Epoladerm confirming transdermal absorption. The maximum plasma concentration (Cmax) was reached at 4 hours post-dose, and plasma Epoladerm remained at 24-hour post-dose for all animals. This data should strengthen the Company’s IND filing in advance of the anticipated start of first-in-human clinical trials.
“This is an important step in the development of Epoladerm and further prepares us for expected clinical trials,” commented Anthony P. Mack, Chairman and CEO of Virpax. “The results of this study underscore the safety of our spray film technology.”
