NanoViricides elaborates on its current assets and plans towards becoming a successful pharmaceutical company intending to revolutionize the treatment of viral infections. The company said, “NV-387, our lead broad-spectrum antiviral drug candidate has completed Phase I clinical trial in healthy subjects with no drop-outs and no reported adverse events, indicative of excellent safety and tolerability in humans. This single drug, NV-387, has been found to be highly active against a number of different types of viruses. In fact, its activity has, in animal models: Resulted in curing lethal lung RSV infection; Substantially bested the activities of approved drugs for Influenza; Substantially bested the activity of Remdesivir against lethal coronavirus infection; and Matched the activity of TPOXX against poxvirus. We believe that this ultra-broad-spectrum antiviral activity of NV-387 became possible because NV-387 is designed to mimic an invariant host feature that over 90% human pathogenic viruses employ for attachment and infection. A single antiviral drug that can effectively treat almost any respiratory viral infection would be a revolutionary development in the treatment of viral diseases, reminiscent of the revolution caused by penicillin in the treatment of bacterial infections, we believe. We are rapidly moving towards Phase II studies to establish effectiveness against a viral disease in humans. We plan on Phase II studies for RSV, with the goal of developing a therapeutic for the treatment of pediatric patients, which is the greatest unmet need in RSV infection. The market sizes for the viral diseases that NV-387 has already been found to be a viable clinical drug candidate as above are substantial…Thus NV-387 alone is poised to propel NanoViricides towards great success in a near-term horizon. We plan to license or co-develop our various drug candidates against multiple viral diseases to other Pharma Companies. In addition, we plan on seeking non-dilutive funding for the development of drugs that are of interest for biodefense. We have already demonstrated the ability to manufacture our own drug candidates at several Kilograms scales in cGMP-compliant processes for clinical trials. Our campus comprises a multi-Kg scale cGMP-compliant manufacturing facility with Class 100 clean rooms. We have demonstrated capabilities for manufacture of the drug substance, and thereafter formulate, fill-finish-and-package the drug products for clinical trials in this facility. We believe that our existing manufacturing facility would be adequate for market entry of NV-387 for the pediatric patients segment when the drug is approved by the FDA. We also have a drug in development against herpesviruses, NV-HHV-1, formulated as a skin cream, that we plan on advancing through clinical trials for regulatory approval as a topical treatment of Shingles/Chickenpox skin rashes, HSV-1 “cold sores”, as well as HSV-2 “genital ulcers”. NV-HHV-1 had completed IND-enabling studies by October 2019 just before the COVID-19 pandemic broke out, whereupon we took up the challenge of developing a highly effective drug to treat all coronavirus infections. We have an oral formulation of NV-HHV-1 in development for systemic use to treat herpesvirus infections.”
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