NanoViricides is advancing its broad-spectrum antiviral candidate NV-387 toward Phase II clinical trials for the treatment of measles.
The company is preparing an Investigational New Drug application protocol for submission to the U.S. Food and Drug Administration.
The candidate also completed a juvenile mouse toxicity study showing no treatment-related adverse effects at the highest dose tested. Having already concluded a Phase I human safety trial, the therapeutic is now undergoing separate Phase II evaluations targeting mpox and the Ebola Bundibugyo virus within the Democratic Republic of Congo.
The FDA granted NV-387 both Orphan Drug Designation and Rare Pediatric Disease Drug Designation for measles. The pediatric designation could make NanoViricides eligible for a Priority Review Voucher following a qualifying marketing application approval, subject to applicable requirements.
Addressing Unmet Needs
This therapeutic pipeline tackles a crucial gap in healthcare as measles infections increase domestically and globally. NanoViricides said that NV-387 remains investigational and has not received approval for treating measles or any other viral disease.
The clinical-stage company creates special purpose nanomaterials for antiviral therapy based on proprietary technology from TheraCour Pharma, Inc. NanoViricides maintains a Memorandum of Understanding with TheraCour for drug development across all antiviral infections, excluding cancer treatments.
The business model relies on licensing technology from TheraCour for specific virus application verticals established at the company’s foundation in 2005. Lead drug candidate NV-387 is also developed to treat respiratory viral infections like respiratory syncytial virus, COVID-19, long COVID, and influenza, alongside smallpox and mpox infections.
Clinical Development Plans
NanoViricides cannot project an exact date for filing an investigational new drug application because of dependence on external collaborators and consultants. The company develops NV-CoV-2 and NV-CoV-2-R independently as COVID-19 treatments, with the latter encapsulating remdesivir developed by Gilead.
The company holds a worldwide exclusive perpetual license from TheraCour for several drug targeting mechanisms covering human immunodeficiency virus, hepatitis viruses, rabies, herpes simplex viruses, varicella-zoster virus, influenza, dengue viruses, Japanese encephalitis virus, west viral virus, and ebola viruses. Pharmaceutical product development requires substantial capital and remains subject to typical industry risk factors regarding safety and effectiveness.
Questions About NV-387 Preclinical Testing and FDA Designations
What preclinical testing did NV-387 complete for measles?
The drug demonstrated antiviral activity in a humanized mouse model and completed a juvenile mouse toxicity study where no treatment-related adverse effects appeared at the highest tested dose.
What regulatory designations has the FDA granted?
The FDA granted NV-387 both Orphan Drug Designation and Rare Pediatric Disease Drug Designation for the treatment of measles.
Which other clinical trials are currently underway?
NV-387 is currently evaluated in separate Phase II clinical trials for Ebola Bundibugyo virus and mpox in the Democratic Republic of Congo.
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