BERWYN, Pa.– Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ:VRPX), a company specializing in developing product candidates for pain management, CNS and anti-viral indications, today announced that it has received a written pre-investigational new drug (pre-IND) response from the U.S. Food and Drug Administration (FDA) for MMS019, its patented and proprietary high-density molecular masking spray under development for use as an anti-viral barrier product. Virpax believes the results of the pre-IND response support further research on MMS019 as an intranasal protective that may limit transmission of the viruses to others. Virpax expects to move forward and pursue a New Drug Application (NDA) for MMS019 as a once daily intranasal treatment. The FDA has indicated that Virpax may pursue an NDA drug approval with the Office of Non-Prescription Drugs. The Company has engaged Syneos Health to assist with the optimal clinical trial design based on an efficient timeline.
“We are very pleased with the response from the FDA. We believe that the initial pathway to move forward with the development of MMS019 has been clarified,” said Anthony P. Mack, Chairman and CEO of Virpax. “The pre-IND meeting provides an opportunity for open communication between the Sponsor and the FDA to discuss the IND development plan and to obtain the FDA’s guidance for clinical studies for the new drug candidate. As our development program proceeds, we will define the strategy for our drug-device combination product candidate, MMS019, for use in an over-the-counter setting as we look to support a consumer-friendly OTC indication.”
Virpax previously announced that it has completed in-vitro, ex-vivo (human mucosal cells) and in-vivo trials for this product candidate. MMS019 demonstrated inhibition of viral replication of SARS-CoV-2 and influenza in animals at much higher ranges than what is encountered by humans in the nasal passages; no adverse effects were observed during the studies. In addition to inhibition of viral replication, the animal studies also demonstrated decreased levels of the virus in animal brain tissue, a potentially important observation as recent studies have shown neurological conditions with survivors of severe Covid.
MMS019 is a drug product candidate based on a type of nanotechnology that enables the exclusive delivery of a metabolically labile peptide drug into the brain on intranasal delivery. MMS019 is manufactured using industrially relevant equipment and processes (high pressure homogenization and spray drying). There is pharmacological evidence of activity of molecular envelope technology (MET) enabled enkephalin in morphine-tolerant animals. The MET nanoparticles are well tolerated via the nasal route at the dose administered. MMS019 demonstrated comparable preclinical activity to morphine in all animal pain models tested without the drug seeking and tolerance associated with opioids.
