BERWYN, Pa.– Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing non-addictive product candidates for pain management, as well as PTSD, CNS disorders and anti-viral indications, reported promising results from preclinical dose range finding studies for Envelta (NES100), Virpax’s endogenous enkephalin intranasal spray for acute and chronic pain, including pain associated with cancer. These findings complement previous positive preclinical toxicology results and support the Company’s continuing development of this potential non-addictive treatment for acute and chronic pain.
Investigational New Drug (IND) enabling studies for Envelta are being performed under a Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health’s (NIH) National Center for Advancing Translational Sciences (NCATS) entered into by Virpax and the NIH in August of 2020. Under the cooperation agreement, the studies are performed and funded by the NIH.
Pursuant to the CRADA, NCATS conducted a 14-day intranasal dose range finding toxicity study of Envelta in rats with a 14-day recovery period. This study showed no adverse related findings in hematology, coagulation and serum chemistry data, with no treatment related toxicology findings or mortality noted. A 14-day intranasal dose range finding toxicity study of Envelta in dogs with a 14-day recovery period was also conducted and showed no adverse toxicologic findings. “These early data appear promising and support our continued quest for safe and effective pain and CNS therapies. We look forward to completing our final IND enabling studies,” noted Dr. Jeff Gudin, Virpax EVP and Chief Medical Officer.
To further evaluate the potential of Envelta as an intranasal treatment for acute and chronic pain, NCATS will complete the remaining preclinical studies to support submission of an IND to the Food and Drug Administration (FDA).
“These preclinical data support and further strengthen the development of Envelta as a potential intranasal enkephalin for the management of cancer and non-cancer pain. We remain focused on the next steps so that we may submit an IND and then initiate a Phase 1 study in humans upon any potential FDA acceptance,” commented Anthony P Mack, Chairman and CEO of Virpax.
