NanoViricides, Inc. (NYSE American: NNVC) has 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), and no maximum tolerated dose was identified. These findings are significant because they could support the inclusion 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, and the drug has received U.S. Food and Drug Administration orphan drug and rare pediatric disease designations for measles.
The positive juvenile safety data is a critical step for NanoViricides, as it potentially broadens the patient population that could benefit from NV-387. The company is creating special purpose nanomaterials for antiviral therapy, and its lead drug candidate NV-387 is being developed as a treatment for RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox and measles. For investors, the latest news and updates relating to NNVC are available in the company’s newsroom at https://ibn.fm/NNVC. However, NanoViricides also disclosed in its fiscal 2026 annual report 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 clinical progress and highlights the challenges of funding lengthy and costly drug development.
The company’s novel nanoviricide class of drug candidates is based on intellectual property, technology, and proprietary know-how of TheraCour Pharma, Inc. NanoViricides holds a worldwide exclusive perpetual license to this technology for several human viral diseases, including HIV/AIDS, Hepatitis B and C, Rabies, Herpes Simplex Virus, Varicella-Zoster Virus, Influenza, Dengue, Ebola/Marburg, and certain Coronaviruses. The company’s business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses. For more information about NanoViricides, visit www.nanoviricides.com. The full press release can be viewed at https://ibn.fm/5QClt.
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