Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ:VRPX), today announced that the Investigational New Drug (IND) Application enabling studies for Envelta™ being performed under a Cooperative Research and Development Agreement (CRADA) entered into by Virpax and the National Center for Advancing Translational Sciences (NCATS) for chronic pain, will also be used as a source for INDs for two additional indications, for cancer pain and Post-Traumatic Stress Disorder (PTSD). NCATS has commenced the IND enabling studies of Envelta to support Virpax’s future application for clearance from the Food and Drug Administration (FDA) to initiate Virpax’s first-in-human clinical trials.
Sheila Mathias, PhD, JD, Chief Scientific Officer of Virpax stated, “Once the Envelta IND enabling studies are submitted to the FDA for acute/chronic pain, the parent IND is expected to be used to cross reference for the PTSD IND. We believe the same Phase I Single Ascending Dose (SAD)/Multiple Ascending Dose (MAD) study could be used to advance all three indications. SAD and MAD studies are typically the first-in-human studies, where we seek to gain information on safety and tolerability, general pharmacokinetic (PK), and pharmacodynamic (PD) characteristics, and identify the maximum tolerated dose.”
About Envelta
Envelta™ is an investigational intranasal formulation intended to improve enkephalin transport to the brain. Enkephalin is a naturally occurring (endogenous) peptide that is not easily administered in its original form. Envelta™ 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 the drug and help carry it to the brain, enabling it to cross the blood-brain barrier to suppress pain by binding to the delta-opioid receptors. Envelta™ has demonstrated analgesic potential in animal models without developing opioid tolerance, withdrawal, respiratory depression, euphoria, or addiction associated with the use of opioids. Once the Envelta IND enabling studies are submitted to the FDA, the data may be cross-referenced to our cancer pain and PTSD INDs.
