Virpax Pharmaceuticals has brought its nasal spray for acute and chronic pain through an early test. With the National Institutes of Health (NIH) footing the bill, Virpax posted a clear toxicology report in a preclinical studies in preparation for filing to study the candidate in humans.
The NIH signed up to support the prospect in 2020 as part of its efforts to advance the development of nonaddictive pain treatments. Virpax’s candidate is a nasal formulation designed to improve transport of enkephalin, a natural opiate receptor agonist, to the brain. Using a nasal delivery device and cartridge, Virpax hopes to get the peptide to the brain via the olfactory nerve pathway.
Virpax is now working to generate the preclinical data needed to test that idea in humans. The push to the clinic advanced with the publication of results from preclinical dose ranging studies that tested the drug candidate for 14 days in rats and dogs.
The NIH’s National Center for Advancing Translational Sciences (NCATS) performed the rat study, which found no adverse related findings in hematology, coagulation and serum chemistry data and no treatment-related toxicology findings or mortality. Similarly, researchers saw no adverse toxicological findings in the study in dogs.
“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,” Virpax CEO Anthony Mack said in a statement.
NCATS will wrap up the remaining preclinical studies needed to file with the FDA to enter the clinic.