NV-387's Slow Decline in Blood Levels Allows Infrequent Dosing for Strong Antiviral Effect

NanoViricides, Inc., a forefront player in developing broad-spectrum antiviral nanomedicines, has announced promising findings related to their leading clinical-stage antiviral candidate, NV-387. This candidate has demonstrated desirable blood concentration profiles following intravenous administration in a non-human primate model, suggesting potential for infrequent dosing schedules.

The study focused on the drug candidate NV-387, which, when administered through a slow bolus intravenous infusion in cynomolgus monkeys, yielded a stable plateau of drug concentration in the bloodstream with a slow decline over 24 hours. This outcome is critical as it supports a once-daily or less frequent dosing regimen, ideal for maintaining therapeutic levels in the body over extended periods. The unique polymeric design of NV-387, which minimizes renal loss, is attributed to this sustained blood level.

NanoViricides has developed an injectable formulation of NV-387, called NV-387 Solution for Injection, Infusion, and Inhalation. This formulation is particularly useful for moderate to severe illnesses due to its sustained blood concentration profile. For severely ill patients, infusion would be appropriate, while inhalation via a handheld nebulizer could deliver the drug directly to the lungs, targeting the virus where it is most needed in severe lung infections.

The broad utility of NV-387 positions it as a versatile antiviral agent, akin to antibiotics. In studies, NV-387 demonstrated the ability to cure lethal lung infections in RSV-infected animals, even when administered orally. This is significant as RSV lacks effective treatment options, with the existing drug ribavirin being both toxic and less effective.

Further studies revealed that NV-387, whether administered intravenously or orally, outperformed approved drugs like Tamiflu, Rapivab, and Xofluza in treating lethal Influenza A/H3N2 lung infections. The drug’s mechanism, which involves mimicking host cell structures to which viruses bind, is believed to offer similar efficacy against Influenza A/H5N1 (Bird Flu) and other viruses.

Moreover, NV-387 has shown potent antiviral activity against a range of coronaviruses, including SARS-CoV-2 pseudovirions. In lethal coronavirus infection models, NV-387 was significantly more effective than remdesivir. This positions NV-387 as a promising candidate for the treatment of COVID-19 and Long COVID, conditions that continue to have substantial health and socioeconomic impacts. Current treatments like Paxlovid have limitations, underscoring the need for new therapeutic options.

NanoViricides, Inc. is dedicated to advancing NV-387 into Phase II human clinical trials for RSV treatment. Additionally, the company is working on another advanced candidate, NV-HHV-1, aimed at treating Shingles rash, HSV-1 "cold sores," and HSV-2 "genital ulcers." The timeline for filing an IND for any of their drugs remains uncertain due to reliance on various external collaborators and consultants.

The company is also developing treatments for a broad spectrum of viral diseases, leveraging TheraCour® nanomedicine technology, licensed from TheraCour Pharma, Inc. NanoViricides holds exclusive, perpetual licenses for developing treatments targeting viruses like HIV, Hepatitis B and C, Rabies, Herpes Simplex, Varicella-Zoster, Influenza, Dengue, Japanese Encephalitis, West Nile, Ebola, Marburg, and certain Coronaviruses.

NanoViricides acknowledges the lengthy and capital-intensive nature of pharmaceutical development. While the path to successful drug development is fraught with uncertainties, the promising preclinical and clinical data for NV-387 offer hope for new, effective antiviral treatments.