NanoViricides advances NV-387 antiviral program, eyes Phase II trials for Mpox

NanoViricides (NYSE-A:NNVC) is preparing a Phase II clinical trial application for its lead antiviral candidate NV-387 to treat Mpox infections in Central Africa, marking a major step in the company’s broader strategy to address a growing range of viral public health threats with no currently approved treatments.

The Connecticut-based biotech firm recently received clearance from the Democratic Republic of Congo’s National Ethics Committee to proceed with the submission following a review of Phase I safety data and promising results from preclinical Mpox studies in lethal animal models.

The company is now producing clinical-grade drug supplies at its cGMP-compliant facility in Shelton, Connecticut.

NV-387 is a host-mimetic antiviral designed to neutralize viruses by mimicking cellular receptors, a mechanism the company says is difficult for viruses to evade. NanoViricides believes the compound has the potential to serve as a first-in-class broad-spectrum therapeutic for multiple deadly infections, including Mpox, Measles, Respiratory Syncytial Virus (RSV), and strains of bird flu such as H5N1.

There is currently no drug approved for Mpox, and Clade 1a/1b variants carry fatality rates of 3% to 4%, with serious implications for pediatric populations, the company said, noting that WHO has maintained its public health emergency designation for the disease in Africa through April 2025.

NanoViricides is also exploring NV-387 as a potential treatment for Measles, which has resurged in the US and Europe due to declining vaccination rates. Preclinical studies are underway using a humanized animal model. The company pointed to similarities in viral entry mechanisms between Measles and RSV — for which NV-387 showed strong efficacy — as a basis for optimism.

Additionally, the company is eyeing bird flu, including the H5N1 strain, as a major emerging threat. NV-387 previously demonstrated superior results to existing antivirals like Tamiflu and Xofluza in animal models of lethal influenza infection. NanoViricides said it intends to position NV-387 as a potential emergency use candidate should human outbreaks of H5N1 escalate.

Looking ahead, NanoViricides plans to pursue additional Phase II trials for NV-387 targeting viral acute respiratory infections and RSV in the US, subject to funding. The drug completed Phase I testing in healthy volunteers with no reported adverse events, and a final report is pending.

As of March 31, the company reported cash and cash equivalents of $2.73 million and an additional $3 million line of credit from its founder. NanoViricides raised $4.57 million through an at-the-market equity offering during the last nine months and said it expects to continue leveraging equity markets to support its clinical pipeline.

The company said it is actively reprioritizing programs in line with available funding while maintaining a focus on pandemic preparedness and unmet medical needs.

Shares of NanoViricides traded higher on the update, up more than 10% in early trade on Friday.