Pain Management Company Virpax Sees Promise in Potential COVID-19 Antiviral OTC
Philadelphia-based Virpax Pharmaceuticals (Nasdaq: VRPX) has been blazing a trail in the development of non-addictive pain treatments, but the small company may first make its mark with an antiviral nasal spray that appears to have potential application against COVID-19.
The company licensed an asset known as AnQlar that has potential to be an OTC (over-the-counter) treatment for COVID-19. Virpax Chief Executive Officer Anthony Mack said it was the asset’s potential as a non-prescription anti-viral medication that caused so much excitement about the company. AnQlar is a chitosan derivative and is a positively charged molecule that binds electrostatically to negatively charged coronaviruses.
In preclinical studies, Mack said Virpax has found the drug to be effective as a prophylactic against the COVID-19 virus. Each time the drug was introduced into a model and came into contact with the introduced virus, AnQlar halted viral replication. As Mack described how it worked, he said the SARS virus is negatively charged. The AnQlar asset is positively-charged, thus the virus is attracted to it. AnQlar surrounds the spike proteins and prohibits them from attaching to the ACE2 receptor in the upper nasal passage.
Mack said that in animal studies, rats that had been used as subjects were dissected and Virpax researchers found no viral brain load. Not only does that suggest AnQlar prohibited viral spread, it also seems to suggest that the medication could eliminate the potential for symptoms related to long COVID.
“This is really exciting stuff,” said Mack.
Virpax anticipated filing its Investigational New Drug application in 2022 in order to move it into human studies. AnQlar will be studied for once-daily prophylactic use. Mack noted that the OTC potential has been appealing to investors. Virpax completed a $40 million fund raising effort earlier this summer – to be used to advance the preclinical development of AnQlar and advance two product candidates to NDA filing. The capital will enable the company a runway through mid-2024 and multiple product development catalyst.
As AnQlar moves through clinical studies, Mack noted that Virpax will have to seek outside partnerships to help bring the medication to market should it pass through the regulatory hurdles. He acknowledged that the company’s leadership team lacks experience with not only the OTC market, but also the antiviral field.
“The OTC space is new to Virpax. We set this company up with pain and CNS (central nervous system) in mind. Having an antiviral product wasn’t one of our goals,” Mack admitted. “While this might not be our area of expertise, we’re happy to contribute to use one of our proprietary drug delivery platforms to contribute to stopping viral spread.”
Virpax also has several assets in preclinical development for these different pain and CNS indications and has global rights to a patented topical spray film delivery technology for osteoarthritis of the knee.
The spray system delivers the nonsteroidal anti-inflammatory drug Diclofenac Epolamine to the skin. Mack said this approach, should it pan out in clinical development, will be beneficial to patients because it allows for easy application without the mess associated with other topical gel medications. At the same time, the spray application maintains comparable skin absorption capabilities to topical creams and gels currently on the market, he said. Virpax anticipates some new data that will support a potential IND in the new year.
Another asset Virpax has licensed is a patented injectable “local anesthetic” liposomal hydrogel technology being developed for postoperative pain management. When it’s injected into the knee or the hip, the hydrogel keeps the pain medication at the site. This keeps the medicine from migrating and ensures effectiveness, Mack said. So far, they have seen the pain medication remain at the site of injection for up to 96 hours. Mack said they anticipate new data that will provide information as to how long the pain control will last.
Virpax is also developing an intranasal cannabidiol asset for the management of epilepsy in adults and children. Mack said they will aim to file a pre-IND with the FDA to receive guidance from the regulatory agency on their clinical program in the first half of 2022. The asset, VRP324, is designed to go directly to the C1 receptor without being metabolized in the liver.
Lastly, Virpax is developing a potential treatment for PTSD (post-traumatic stress disorder). Using MET (molecular envelope technology), the same innovative delivery system being used in AnQlar, Virpax aims to improve the transport of enkephalin through the blood-brain barrier. The MET protects enkephalin from biodegrading, which allows enkephalins to attach to the delta receptors and control pain without the concerns of opioid related side effects like respiratory depression, drug seeking and drug tolerance as demonstrated in animal studies versus morphine, Mack said.
The company is looking at broad applications for this beyond PTSD to include cancer pain once they complete the pre-IND enabling trials and receive the green light from the FDA to initiate Phase 1 studies.
“If it can do in humans what it has done in animals, you’ll have a really good option for physicians to use that may eliminate opioid related side effects,” Mack said.