BERWYN, Pa.– Virpax® Pharmaceuticals, Inc., a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and anti-viral barrier indications, today announced that it expects to submit an Investigational New Drug Application (IND) for Envelta in mid-2024 following review of comments made by the US Food and Drug Administration on the Company’s Pre-IND submission. If successful, that would allow clinical trials to begin by the middle of 2024.
Envelta (MET-LENK) is the Company’s non-addictive pain product candidate for acute and chronic pain that is being funded under an in-kind grant from the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH). Envelta utilizes a novel and patented intranasal drug delivery system, Molecular Envelope Technology (MET) to bypass the blood-brain barrier. The MET was developed by Nanomerics, Ltd., a UK-based nanotechnology research and development company that has licensed its MET-LENK to Virpax. The nose-to-brain MET platform protects molecules from biodegrading and enhances the bioavailability of product candidates on its transport to the brain.
The initial Envelta dose ranging studies in rats and dogs have been completed. The 14-day rat dose range finding study (DRF) showed no treatment related clinical signs or mortality. In addition, there were no related findings in hematology, coagulation, and serum chemistry data. The 14-day DRF study in dogs also showed no treatment related mortality or findings in body temperature, body weight, food consumption, and ophthalmic exam. From an efficacy perspective, a dose-response with intranasal MET-LENK was noted in a Complete Freund’s Adjuvant (CFA) anti-hyperalgesia model versus an intranasal placebo and subcutaneous morphine. Administration of the high dose MET-LENK (30 mg/kg) significantly decreased hypersensitivity in treated animals compared to CFA control.
“There is a significant unmet need for effective analgesics with limited or no abuse potential. Our research on Envelta suggests that there is a clear efficacy signal with minimal adverse effects noted in animals in all of our head-to-head comparisons to morphine. Using our novel MET, leucine-enkephalin can be delivered to the brain via an intranasal formulation of nanoparticles which helps to protect from biodegradation. If human data confirms analgesic benefit without drug tolerance or drug-seeking behavior, this formulation may represent a potential broad-spectrum molecule to treat severe pain and CNS disorders,” stated Anthony P. Mack, Chairman and CEO of Virpax. “We are grateful to the FDA for the thorough and clear direction that was provided to us in our pre-IND meeting. With the ongoing support of our NIH colleagues, we expect to continue advancing Envelta through preclinical development leading up to first in human trials in 2024.”
