Virpax Pharmaceuticals Inc. (NASDAQ: VRPX) stock gains by 98.21% in the current market trading session. Virpax is leveraging its unique technology to optimize and tailor medication delivery for branded, non-addictive pain treatment product candidates. Virpax is requesting FDA clearance for three of its proprietary medication delivery systems.
What’s happening with VRPX stock?
MMS019, Virpax Pharmaceuticals’ patented and unique high-density molecular masking spray under production as an anti-viral barrier solution, has got a written pre-investigational new drug (pre-IND) statement from the US Food and Drug Administration. The results of the pre-IND reaction, according to Virpax, encourage future study on MMS019 as intranasal protection that may restrict viral transmission to others. MMS019 as a once-daily intranasal therapy is expected to be pursued by Virpax as a New Drug Application (NDA). The Office of Non-Prescription Drugs at the FDA has suggested that Virpax may seek an NDA medication approval. Syneos Health has been hired by the company to help with the best clinical trial design based on a short timeframe.
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Virpax previously reported that in-vitro, ex-vivo, and in-vivo studies for this product candidate had been completed. MMS019 inhibited viral replication of SARS-CoV-2 and influenza in animals at considerably greater concentrations than those seen in human nasal passages, with no side effects reported throughout the tests. In addition to inhibiting viral multiplication, the animal tests revealed lower amounts of the virus in the brain tissue of the animals
Anthony P. Mack, Chairman, and CEO of Virpax commented,
They are quite happy with the FDA’s reaction. They think the starting road to go forward with MMS019 development has been established. The pre-IND conference allows the Sponsor and the FDA to communicate openly about the IND development project and get FDA recommendations for clinical trials for the novel drug candidate. They will establish the approach for their drug-device combination product candidate, MMS019, for use in an over-the-counter context as their research program progresses, as they want to promote a consumer-friendly OTC indication.