BERYWN, PA — In a significant move that promises to reshape the future of pain management, Virpax Pharmaceuticals, Inc. (NASDAQ: VRPX) recently announced its intent to submit an Investigational New Drug Application (IND) for Envelta in mid-2024. This follows a review by the US Food and Drug Administration (FDA) on the Company’s Pre-IND submission. If successful, clinical trials could commence by the middle of the same year.
Envelta (MET-LENK) is Virpax’s proprietary non-addictive pain product candidate for acute and chronic pain. Its development has been funded under an in-kind grant from the National Center for Advancing Translational Sciences (NCATS), a part of the National Institutes of Health (NIH).
The innovative aspect of Envelta lies in its delivery system. It leverages a patented intranasal drug delivery system called Molecular Envelope Technology (MET), which bypasses the blood-brain barrier. This technology was developed by Nanomerics, Ltd., a UK-based nanotechnology research and development company, which has licensed its MET-LENK to Virpax. The nose-to-brain MET platform protects molecules from biodegrading and enhances the bioavailability of product candidates, ensuring effective delivery to the brain.
The initial dose-ranging studies for Envelta in rats and dogs have been successfully completed. The 14-day rat dose range finding study (DRF) showed no treatment-related clinical signs or mortality. Additionally, there were no related findings in hematology, coagulation, and serum chemistry data. The parallel 14-day DRF study in dogs also demonstrated 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.
Reflecting on these encouraging results, Anthony P. Mack, Chairman and CEO of Virpax, said, “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.” He further added, “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.”
The positive feedback from the FDA and the successful completion of preclinical studies make Envelta a promising candidate in the quest for non-addictive pain management solutions. As Virpax Pharmaceuticals continues to advance Envelta through preclinical development with ongoing NIH support, the medical community and avid investors will undoubtedly be watching closely. The anticipated commencement of human trials in 2024 marks an exciting new chapter in the company’s journey and its commitment to innovative, safe, and effective pain management solutions.
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