NanoViricides, Inc. (NYSE American: NNVC) announced positive results from a juvenile mouse study evaluating the safety, tolerability, and toxicity of its broad-spectrum antiviral drug NV-387, supporting its potential advancement into pediatric clinical trials. The 12-day repeated-dose study found NV-387 Oral Gummies were well tolerated at all tested dose levels, with no mortality, systemic toxicity, or treatment-related adverse effects. The highest tested dose of 3,690 mg/kg/day was established as the No Observed Adverse Effect Level (NOAEL), with no maximum tolerated dose identified.
The company believes the findings could support pediatric enrollment in future clinical trials for Ebola, Mpox, and measles, subject to further clinical development and regulatory requirements. NV-387 is currently being evaluated in Phase II clinical trials for Ebola and Mpox in the Democratic Republic of Congo. The drug has also received U.S. Food and Drug Administration orphan drug and rare pediatric disease designations for measles, underscoring its potential to address serious unmet medical needs in pediatric populations.
These safety results are significant because they suggest NV-387 may be safe for children, a critical step for developing treatments against deadly viruses that disproportionately affect pediatric patients in outbreak settings. If subsequent trials confirm efficacy, NV-387 could become a key weapon in the fight against Ebola, Mpox, and measles, diseases that often lack safe, broad-spectrum antiviral options for children. The juvenile study's clean safety profile at high doses reduces the risk of adverse events in future pediatric trials, potentially accelerating clinical development.
Separately, NanoViricides disclosed that its fiscal 2026 annual report included an auditor statement expressing substantial doubt about its ability to continue as a going concern. The company is pursuing potential nondilutive funding for clinical development while maintaining access to equity-based financing, including an at-the-market share offering facility. This financial uncertainty contrasts with the promising clinical data, highlighting the challenges small biotech firms face in funding costly drug development.
NanoViricides, a clinical-stage company creating special purpose nanomaterials for antiviral therapy, is developing NV-387 as a treatment for RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox and measles. The company's novel nanoviricide class of drug candidates is based on intellectual property from TheraCour Pharma, Inc. For more information, visit www.nanoviricides.com.
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