– AnQlar™ has already demonstrated antiviral activity against influenza and SARS-CoV-2 in three preclinical studies –
— The FDA has notified Virpax that the company is authorized to file an NDS (New Drug Submission) application with the Office of Non-Prescription Drugs —
Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in the development of non-addictive drug candidates to manage pain as well as post-traumatic stress disorder (PTSD), central nervous system (CNS) disorders and certain viral diseases, has extended its agreement exclusive license agreement for AnQlar™ with Nanomerics Ltd., which gives Virpax exclusive worldwide development and marketing rights.
Virpax has completed studies in vitro, ex-vivo (human mucous cells) and live (rats) on AnQlar, which showed that AnQlar inhibited viral replication of SARS-CoV-2 and influenza in animals at higher levels than seen in human nasal passages. No side effects were observed during the studies. The studies also found lower levels of the virus in the animals’ brain tissue. Virpax expects studies allowing Investigational New Drug (IND) status to be completed by the fourth quarter of fiscal year 2022 and expects to file for OTC drug authorization.
“We would like to thank our partner, Nanomerics, for working with the Company to restructure our original agreement, which extends North American rights to a worldwide agreement, and replaces all commercial steps and royalties through a profit sharing agreement. This makes it easier for us to apply for potential over-the-counter (OTC) drug status with the FDA for AnQlar,” said Christopher M. Chipman, Chief Financial Officer and Corporate Secretary of Virpax.
“Getting global rights to AnQlar is consistent with our international business model and puts the company in a better position to enter into strategic alliances or pursue commercial opportunities for this drug candidate,” commented Anthony P. Mack. , CEO of Virpax.
About AnQlar™
AnQlar (GCPQ) is a positively charged chitosan derivative that binds to the electrostatic charge of negatively charged viruses, such as SARS-CoV-2 and influenza. AnQlar can prevent the binding of coronavirus to the ACE-2 membrane receptor which mediates viral infection. This molecule can have two modes of action: it has virucidal properties and inhibits the penetration of the virus into cells via the ACE-2 receptor.
AnQlar is a mucoadhesive polymer with an extended nasal retention time. Applying AnQlar to the nasal mucosa can create a barrier against viral infection by inhibiting virus binding. Preliminary data obtained in vitro, ex-vivo and live showed that AnQlar inhibits SARS-CoV-2 replication and can inhibit viral proliferation as well as viral load in the brain.
About Nanomerics
Nanomerics Ltd is a specialty pharmaceutical company based in London, UK. Nanomerics originated at University College London (UCL) and was created to commercialize its biocompatible polymers for drug delivery and other applications. Nanomerics’ proprietary technology is based on world-class know-how and world-class scientific leadership in polymer nanotechnology. Nanomerics creates unique patented pharmaceutical products, based on quality science. For example, the Molecular Envelope Technology (MET) developed by the company is a unique patented biocompatible polymer that revolutionizes bioavailability in the target tissue. Nanomerics’ TEM won first prize in the Royal Society of Chemistry’s Emerging Technologies competition. The founders, Prof. Ijeoma F. Uchegbu and Prof. Andreas G. Schätzlein, developed this technology at the universities of Strathclyde and Glasgow, then at the faculty of pharmacy of UCL. For more information, visit www.nanomerics.com.
About Virpax Pharmaceuticals
Virpax is developing drug candidates for non-addictive pain management and neurological disorders, based on its proprietary technologies, to optimize and target drug delivery. Virpax is initially seeking FDA approval for its three patented drug delivery platforms. Epoladerm™ is a film-forming topical formulation of diclofenac spray, developed for the management of osteoarthritis pain. Probudur™ is a single injection, long-acting liposomal bupivacaine formulation developed for the management of post-operative pain. Envelta™ is an enkephalin formulation using intranasal Molecular Envelope Technology (MET) developed for the management of pain, particularly in oncology, as well as for the management of post-traumatic stress disorder ( PTSD), under the name of PES200. MET technology is also used in AnQlar™, a drug candidate aimed at inhibiting the replication of influenza or SARS-CoV-2 viruses. Virpax recently acquired worldwide rights to VRP324, a drug candidate for the nasal delivery of a cannabidiol (CBD) sold in pharmacies for the management of epilepsy in children (a rare pediatric disease) and adults. For more information, visit www.virpaxpharma.com.
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