NanoViricides is leveraging its expertise in antiviral drugs to find a cure for COVID-19.
The race to develop a safe and effective vaccine to prevent coronavirus infection appears to be nearing the finish line, with more than 10 coronavirus vaccine programs in phase 3 trials. Vaccines from Pfizer and partner BioNTech, Moderna, and Novavax are all getting fast-tracked for late-stage studies, and some may even get emergency use authorization by the end of the year.
Meanwhile, drugmakers like Eli Lilly and Company and Regeneron Pharmaceuticals are making progress toward monoclonal antibody treatments that could potentially help alleviate COVID-19 symptoms and reduce the need for hospitalization. With more than 12 million COVID-19 cases and over 250,000 deaths in the United States, what remains elusive is an actual cure for COVID-19 itself.
Late last year, NanoViricides was in the process of filing an Investigational New Drug application with the U.S. Food and Drug Administration for NV-HHV-101, its lead drug candidate for the treatment of shingles rash. When the COVID-19 outbreaks struck in Asia and Europe, NanoViricides decided to put everything on hold in order to leverage its expertise in the treatment of viral infections to find a COVID-19 cure.
“The SARS-CoV-2 virus is highly contagious and can cause respiratory tract infections that range from mild to deadly,” said Anil R. Diwan, founder and president of NanoViricides. “We clearly saw the need to shift all of our attention and resources to address the pandemic.”
As the inventor of TheraCour technology, Diwan holds two very broad international patents for antiviral drug technologies. He is a prolific inventor and serial entrepreneur who holds a doctorate in biochemical engineering from Rice University and a bachelor’s degree in technology from the Indian Institute of Technology Bombay, in Mumbai, India.
NanoViricides has been collaborating with Diwan’s other companies, TheraCour Pharma and AllExcel, to develop an entirely new class of drugs based on “nanomachines” that work against a virus by binding with ligands that mimic the host cell’s receptor to dismantle the virus. In effect, this blocks the reinfection cycle, going beyond what antibodies and immunotherapeutics do.
By January 2020, NanoViricides had identified a novel drug candidate, NV-CoV-1, which acts as an adjuvant to remdesivir, a medication made by Gilead Sciences and approved for the treatment of certain COVID-19 patients. Preliminary tests have shown that NV-CoV-1-R is more effective than remdesivir alone in cell culture and animal studies in fighting the virus.
“Attacking the reinfection cycle with NV-CoV-1 and simultaneously attacking the replication cycle with an encapsulated drug should produce a cure for the virus infection, scientifically speaking,” said Diwan of the NanoViricides approach in developing NV-CoV-1-R.
He added: “We chose remdesivir to develop this double-barrel attack on the virus because it is already known to work well in blocking virus replication and is FDA approved.”
Unfortunately, remdesivir suffers from the issue that much of it is rapidly metabolized in the body, and thus its full potential that is seen in cell culture studies is not realized in human clinical studies.
“Encapsulation is a process of ‘hiding’ remdesivir inside NV-CoV-1 so that it is protected from bodily metabolism,” Diwan said. “It is a well-known feature of nanomedicines that we are harnessing here to maximize the effectiveness of remdesivir, in addition to the double-barrel attack on the virus.”
“Our development timetable is very aggressive, while we are also focused on safety,” said Diwan, who was dubbed Researcher of the Year in 2014 by Business New Haven, a Connecticut-area business journal. “The effectiveness of NV-CoV-1-R in cell culture and animal models has led us to believe that it is worthy of human clinical development.”
By all measures, a novel drug candidate usually entails a significantly long process for approval. Fortunately, NanoViricides has taken steps to accelerate the timeline by engaging a well-established preclinical drug development firm with nearly 40 years of experience. Calvert Labs will perform safety pharmacology studies on NV-CoV-1-R. In the meantime, NanoViricides will file a Pre-Investigational New Drug application with the FDA to obtain guidance, ensure the smooth flow of the process and minimize the risk of failure of the application.
NanoViricides is confident that it has sufficient funds to move NV-CoV-1-R into initial human clinical trials. Once they are underway, NanoViricides plans to resume developing its shingles drug candidate, along with a portfolio of drug candidates for other viral infections, including oral and genital herpes, swine flu, bird flu, seasonal influenza, HIV, hepatitis C, rabies, dengue fever, and Ebola. While investors have long recognized the potential of NanoViricides to address many multibillion-dollar market spaces, they are embracing Diwan’s vision and focus on COVID-19 and hoping that the company’s promising technology can indeed help put an end to the pandemic.
NanoViricides Inc. is publicly traded on the New York Stock Exchange under the symbol NNVC. To learn more about NanoViricides, please visit nanoviricides.com.
Originally published on December 7, 2020 at https://www.usatoday.com/story/sponsor-story/nanoviricides/2020/12/07/why-nanomachines-could-potentially-end-covid-19-pandemic/3786631001/