The Company has been working on a drug candidate to address the COVID-19 and has made significant progress in this regard
New York, New York--(Newsfile Corp. - March 5, 2020) - NanoViricides, Inc. (NYSE American: NNVC) (the "Company") is a nano-biopharmaceutical Company at the development stage, with proprietary and patented drug development work focused on viral diseases. The Company has recently been in the news for being one of the few biotechnology companies that is actively working on developing a drug that can treat COVID-19, the coronaviral pneumonia disease which is caused by the SARS-CoV-2 virus, aka, 2019-nCoV, also known as the Wuhan coronavirus. After originating in Wuhan, within the Hubei province in China, COVID-19 has affected more than 90,000 people across the globe, in more than 60 countries, including 11 deaths in the United States and disease occurrence in both West Coast and East Coast states. The extremely stringent quarantine measures implemented by China, with similar measures adopted in other affected areas, has resulted in global financial markets losing hundreds of billions of dollars in value. Long term school closings are already occurring in Japan, South Korea, and now in the USA as well.
The COVID-19 virus belongs to the same family of viruses that cause the Severe Acute Respiratory Syndrome (SARS) and the Middle-East Respiratory Syndrome (MERS) diseases. NanoViricides' CEO Dr. Anil Diwan has prior experience working on research associated with MERS which is why the Company could initiate its drug development process rapidly. The management believes that with governmental support, as well as support from international agencies, they have the capability to release a drug in the near future. NanoViricides' research team claims to have found broad-spectrum virus-binding ligands that are expected to attack the coronavirus at the same points that the virus uses to bind to its cognate cellular receptor, namely ACE-2 (angiotensin converting enzyme type 2), using molecular modeling based on known SARS-CoV and ACE2 interactions. The management intends to perform initial testing of these drug candidates for safety and effectiveness in cell culture studies in its own BSL-2 virology laboratory at its Shelton campus, using low-threat coronavirus strains that have been normally circulating in human population. This is a major development in terms of the rollout of any COVID-19 drug.
Other drug development efforts to combat COVID-19 include new discovery of antibodies, by companies including Regeneron, and the existing nucloside analog drug remedesivir by Gliead. While remdesivir is now in three clinical trials, two in China, and one in the USA, it has a checkered past. Despite having shown effectiveness in animal models of Ebola virus, it failed in a clinical trial for this disease conducted by the NIH and international agencies. Also, its protocol involves 10 days of 1-hour infusions daily, which leaves a lot to be desired. Antibody development against a virus takes several years of discovery and development efforts, because of the cycle of creating and screening the antibodies in mice, then taking the effective ones and converting them into humanized antibodies, then further modifying them, usually by PEGylation, so that they can be used for infusions in patients. Also viruses readily mutate and escape antibody drugs as well as vaccines. In light of this, the NanoViricides platform technology appears to have superior features, and may be the only game in town in the near future.
If the NanoViricides drug testing is successful, they can make kilogram quantities in just a few weeks. That would be sufficient to treat several hundreds to a few thousands of patients, from just a single production batch. They already have cGMP-capable production capability for this. Also, one of their drug candidates on this platform technology has already gone through full blown safety/toxicology studies and is in IND preparaion stage. Thus their drug candidate can be moved to human clinical trials and exploratory usage by regulatory authorities provided that there is the will to do so. The economic and human impact of the virus is now providing the political will for combating this virus, as seen from the recent $8.3 billion coronavirus related funding approved by the US Congress, and more than $10 billion committed by the Chinese government.
Dr. Anil Diwan, CEO, who is actively working on a drug to counter COVID-19, provided the following statement: "It is well recognized that development of vaccines takes a long time, and that vaccines can often be ineffective against viruses due to viral mutations that lead to emergence of resistant strains." The management is working on developing necessary collaborations in China to take the program further assuming that an effective drug candidate is identified soon and they intend to solicit interest and financing from government agencies in order to accelerate the Company's work on the coronaviruses and novel pathogens.
Before its work on COVID-19 became public, NanoViricides was in the news for its research on three HerpeCide™ drug development programs: dermal topical treatments for Herpes Simplex Virus Type 1 (HSV-1), Herpes Simplex Virus Type 2 (HSV-2) and Varicella Zoster Virus (VZV) which causes chickenpox and shingles. Its core drug candidate is NV-HHV-101, a skin cream for topical treatment of shingles rash caused by VZV which has already completed its GLP studies and is at the IND application phase before heading to Phase 1 of human trials. It is worth noting that there are between 500,000 to 1 million cases of shingles each year in the US alone and the only serious drug active in this space is preventive medication like the Shingrix vaccine. The Company's topical cream has a large addressable market across the globe and its management recently raised sufficient research for 2020. With its multi-kilogram-scale c-GMP capable manufacturing facility in Shelton, Connecticut, the Company appears well-positioned to move forward to the next level in its research for both, COVID-19 as well as HerpeCide™.
