BERWYN, PA — Virpax Pharmaceuticals, Inc. (NASDAQ: VRPX) announced it will pursue an OTC Intranasal Medical Device Consumer regulatory pathway for AnQlar™, the Company’s product candidate being developed as a prophylactic antiviral barrier against influenza and SARS-CoV-2.
“We believe that AnQlar, upon successful development and commercialization, may be a 24-hour prophylactic medical device that can be used as an intranasal barrier against COVID, Influenza and most negatively charged viruses, including the Rhinovirus. We expect the OTC non-prescription Medical Device pathway to provide a faster drug development timeline and global approval track than the OTC non-prescription New Drug Application pathway that we had originally pursued for AnQlar,” stated Anthony P. Mack, Chairman and CEO of Virpax.
“Additionally, we intend to validate AnQlar’s claims and assess its value for commercialization in North America, Europe and Asia,” continued Mr. Mack. “We now have two product candidates, AnQlar and Epoladerm™, in our OTC pipeline and will seek to license out or partner these assets as we continue to focus our efforts on our prescription drug pipeline.”
To support the OTC Medical Device application, Virpax plans to submit AnQlar’s completed in-vitro study, ex-vivo study using human mucosal cells, in-vivo study in rats, toxicology study and its pharmacokinetics (PK) characteristics studies to the FDA. Additionally, the Company will include AnQlar’s completed safety-pharmacology studies, drug-drug interaction studies and its virology studies evaluating AnQlar’s antiviral properties against two variants of SARS-CoV-2 in a SARS-CoV-2 mouse model to the FDA. For the OTC medical device application, Virpax anticipates that it will have to complete stability testing, human factors testing for medical devices, safety studies and supplementary in-vitro studies.
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