Virpax Pharmaceuticals, Inc. (NASDAQ: VRPX) is a biopharmaceutical company that is focused on the research and development of treatment candidates for pain management, central nervous system (CNS), and anti-viral applications. Shares of the biopharma company shot up 111% during early trading on Tuesday, August 17, 2021. Over the past three months, Virpax Pharmaceuticals has seen average daily volume of 2.27 million shares. However, volume of 43.61 million shares or dollar volume of $387.26 million, has already exchanged hands through early trading on Tuesday.
Shares of Virpax Pharmaceuticals surged after the company announced it has received a written pre-investigational new drug (pre-IND) response from the U.S. FDA regarding MMS019, a patented high-density molecular masking spray for use as a anti-viral barrier. Management believes the pre-IND response will drive support for further research on its MMS019 candidate and its potential ability to limit viral transmission.
The FDA’s guidance suggested that Virpax Pharmaceuticals could move forward with a New Drug Application (NDA) for MMS019 with the Office of Non-Prescription Drugs. Virpax has also announced that it is engaging Syneos Health to assist with clinical trial design and an effective timeline.
In the previously-announced completed in-virto, and in-vivo trials for MMS019, the candidate showed the ability to inhibit viral replication of the SARS-CoV-2 and influenza viruses in animals. It should be noted that the animals had much higher ranges of the virus in their nasal passages than what is typically seen in humans.
Not only were no adverse reactions reported, but MMS019 demonstrated abilities to decrease viral loads in animal brain tissue. This is a significant finding, as neurological conditions have been seen in human patients living with 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,” 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.”
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