- The shares of Virpax Pharmaceuticals, Inc. (NASDAQ:VRPX) increased 265.48%. This is why it happened.
The shares of Virpax Pharmaceuticals, Inc. (NASDAQ:VRPX) – a company specializing in developing product candidates for pain management, CNS, and anti-viral indications – increased 265.48%, going from a previous close of $4.20 to $15.35. Investors responded positively to Virpax Pharmaceuticals announcing 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.
And 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. Going forward, Virpax is expecting to pursue a New Drug Application (NDA) for MMS019 as a once-daily intranasal treatment. The FDA 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.
Virpax had previously announced that it has completed in-vitro, ex-vivo (human mucosal cells) and in-vivo trials for this product candidate. And 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.
“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. 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.”
— Anthony P. Mack, Chairman and CEO of Virpax
Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.