NanoViricides, Inc. (NYSE American: NNVC), a clinical-stage company developing special purpose nanomaterials for antiviral therapy, announced positive results from a juvenile mouse study evaluating the safety, tolerability, and toxicity of its broad-spectrum antiviral drug NV-387. The 12-day repeated-dose study found that 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. These findings are significant because they could support the enrollment of pediatric patients 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. The positive juvenile safety data are particularly important given the lack of approved treatments for these diseases in children, and they pave the way for expanding NV-387's development into pediatric populations. However, NanoViricides also 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 could impact the company's ability to advance NV-387, but the positive safety results may help attract additional funding or partnerships.
NanoViricides is creating special purpose nanomaterials for antiviral therapy based on its novel nanoviricide class of drug candidates. The company's lead drug candidate, NV-387, is a broad-spectrum antiviral being developed for RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox and Measles. For more information about NanoViricides, visit www.nanoviricides.com. The latest news and updates relating to NNVC are available in the company's newsroom at https://ibn.fm/NNVC. To view the full press release, visit https://ibn.fm/5QClt.
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