DGAP-News Virpax(R) Pharmaceuticals Inc.: Virpax Begins IND Enabling Studies of Envelta(TM)
DGAP-News: Virpax(R) Pharmaceuticals Inc. / Key word(s): Miscellaneous
Virpax Begins IND Enabling Studies of Envelta(TM)
WEST CHESTER, PA / ACCESSWIRE / February 23, 2021 / Virpax(R) Pharmaceuticals Inc. ("Virpax" or the "Company") (NASDAQ:VRPX), today announced that according to the Cooperative Research and Development Agreement ("CRADA") entered into between Virpax and the National Center for Advancing Translational Sciences ("NCATS"), an institute/center of the National Institutes of Health ("NIH"), U.S. Department of Health and Human Services, the NCATS has begun the Investigational New Drug ("IND") enabling studies of Envelta(TM) for Virpax to support Virpax's future application for clearance from the FDA to initiate its first-in-human ("FIH") clinical trials.
Anthony P. Mack, Chairman and CEO of Virpax stated, "The commencement of these critical pre-clinical studies takes us one step closer to the clinic. Dr. Jeffrey Gudin, principal investigator and co-founder of Virpax, has been working in partnership with the NCATS since we announced the CRADA in August 2020. We believe that the NIH/NCATS collaborative agreement will facilitate maintaining momentum for our team in both our pre-clinical and future clinical development strategies."
Envelta(TM) is an intranasal enkephalin drug product candidate formulation based on nanotechnology which enables the delivery of the drug product to the brain. Enkephalin is a naturally occurring (endogenous) peptide that is not easily administered in its original form. Envelta(TM) is an investigational formulation delivered via the nasal route with the potential to improve enkephalin transport to the brain. Envelta(TM) uses a preassembled device and cartridge to propel the enkephalin formulation through the nose to the brain by flowing along the olfactory nerve pathway. The Molecular Envelope Technology is designed to protect and help carry the drug to the brain, crossing the blood brain barrier and suppressing pain by binding to the delta-opioid receptors. Envelta(TM) has demonstrated analgesic potential in animal models without developing opioid tolerance, withdrawal, respiratory depression, euphoria, or addiction associated with the use of opioids.