BERWYN, PA — Virpax Pharmaceuticals, Inc. (NASDAQ: VRPX), a company specializing in developing pharmaceutical product candidates for pain management, this week announced the results of an animal study model for MMS019, its anti-viral product candidate for respiratory viruses. MMS019 is a high-density molecular masking spray the Company is developing as an anti-viral barrier. The Company intends for this formulation to be delivered using a preassembled device and cartridge to propel the High-Density Molecular Spray formulation into the nose.
Professor Krzysztof Pyrc, a virology specialist [and head of the Virology Laboratory at the Małopolska Biotechnology Center of the Jagiellonian] at the University in Krakow, Poland, who led the study, stated, “While the initial viral load given to the animals was much higher than what is encountered by humans, we demonstrated an inhibition of viral replication in the nasal passages. This is very exciting as it supports further research on our hypothesis that MMS019 may not only protect users that apply the mask, but also may limit transmission of the virus to others.”
Dr. Jeff Gudin, Chief Medical Officer and co-founder of Virpax added, “In addition to inhibition of viral replication, the study also demonstrated decreased levels of the virus in animal brain tissue, an important observation as recent studies have shown neurological conditions with survivors of severe Covid. We are encouraged by these results and have engaged Syneos Health to assist with our regulatory pathway and drug development trials required to file an NDA for FDA approval.”
The animal study model included transgenic mice expressing the human ACE2 protein under the human cytokeratin 18 promoter (a type of protein found on epithelial cells, inside and outside of the body). Each experimental group consisted of 10 animals with 14 animals in the control group. MMS019 was administered once daily intranasally in the treatment group, and the control group received remdesivir intramuscularly.
Initially, the animals were infected intranasally with the SARS-CoV-2 virus. The virus was amplified and titrated in commonly used cell cultures [Vero cells]. Mice received MMS019 or remdesivir every 24 hours from Day 1 until Day 6 post-infection.
On day 6 post-infection, the animals were euthanized, and selected tissues were collected for analysis; viral RNA was isolated, and the viral infection was quantified by means of the RT-qPCR system that detects genetic material of the virus using a lab technique called polymerase chain reaction (PCR). The initial viral titer was comparatively higher than would be contained in an infected human droplet. However, after treatment with MMS019, there was a marked inhibition of viral replication in the mouse nasal passages, and decreased levels of the virus were also recorded for the brain tissue, indicating the limited systemic infection. No adverse effects were observed during the experiment.
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