Virpax Pharmaceuticals (NSDQ:VRPX) today announced promising results from preclinical studies for its Envelta intranasal spray.
Berwyn, Pennsylvania-based Virpax designed Envelta (NES100), an endogenous enkephalin intranasal spray, for treating acute and chronic pain, including pain associated with cancer.
According to a news release, findings from preclinical dose range-finding studies for Envelta complement previous positive preclinical toxicology results and support the company’s development of the potential non-addictive treatment for pain. The company is currently conducting FDA investigational new drug (IND) enabling studies under a cooperative research and development agreement with the National Institutes of Health’s (NIH) National Center for Advancing Translational Sciences (NCATS).
NCATS conducted a 14-day intranasal dose range-finding toxicity study of Envelta in rats with a 14-day recovery period, showing no adverse related findings in hematology, coagulation and serum chemistry data. Another study of Envelta in dogs showed no adverse toxicologic findings.
Further evaluations of Envelta will be completed by NCATS to support the submission of an IND application to the FDA, Virpax said.
Envelta uses a preassembled device and cartridge to propel the enkephalin formulation through the nose to the brian by flowing along the olfactory nerve pathway, with Virpax’s molecular envelope technology designed to protect the drug and help carry it to the brain across the blood-brain barrier.
“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,” Virpax Chairman and CEO Anthony P. Mack said in the release. “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.”