NanoViricides, Inc. (NYSE American: NNVC) announced that a Phase II clinical trial of its antiviral candidate NV-387 for the treatment of MPox is expected to begin soon in the Democratic Republic of Congo, with site preparation and staff training scheduled for early April 2026. The study, already approved by the DRC regulatory agency, will evaluate the safety and effectiveness of NV-387 against Clade I MPox, as the company advances regulatory development and seeks Orphan Drug Designation from the U.S. FDA. This announcement marks a significant step for NanoViricides as it moves its lead drug candidate into human trials for a viral disease that has posed global health challenges.
NV-387 is a broad-spectrum antiviral drug that the company plans to develop as a treatment for respiratory viral infections including RSV, COVID-19, Long COVID, and influenza, as well as MPox and smallpox infections. The Phase II trial in the DRC is particularly important because Clade I MPox is considered more severe than the Clade II strain that caused the 2022 global outbreak. By targeting this clade, NanoViricides is addressing a critical unmet medical need in regions where MPox is endemic. The company is also pursuing Orphan Drug Designation, which could provide incentives such as tax credits and market exclusivity if the drug is approved.
According to the press release, the company’s business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals. NanoViricides holds a worldwide exclusive perpetual license to TheraCour's nanomedicine technology for several viruses. The company's platform technology involves creating special purpose nanomaterials designed to attack viruses directly. NV-387 is the API (active pharmaceutical ingredient) used in both NV-CoV-2 (without remdesivir) and NV-CoV-2-R (with remdesivir encapsulated). The company believes that since remdesivir is already FDA-approved, its drug candidate encapsulating remdesivir is likely to be approvable if safety is comparable.
The initiation of this trial comes as MPox continues to spread in parts of Africa, and the World Health Organization has declared it a Public Health Emergency of International Concern. The DRC has reported thousands of cases and hundreds of deaths, underscoring the urgency for effective treatments. NanoViricides' NV-387 could offer a novel therapeutic option if it demonstrates safety and efficacy in the Phase II study. The company also has other drug candidates in development, including NV-HHV-1 for shingles, and is exploring treatments for herpes, influenza, HIV, hepatitis C, rabies, dengue, and Ebola, among others.
Investors can find the latest news and updates relating to NNVC in the company’s newsroom at https://ibn.fm/NNVC. The full press release is available at https://ibn.fm/4Ckhk. As with any drug development, there are risks, including the lengthy and capital-intensive nature of clinical trials, and no assurance that NV-387 will ultimately receive regulatory approval.
