Analysts at Zacks have issued a new report on clinical stage biotech NanoViricides (NYSE-A:NNVC), saying that its lead drug candiate NV-387 shows broad-spectrum antiviral potential ahead of a Phase 2 clinical trial for the treatment of Mpox.
The trial will take place in the Democratic Republic of Congo, where the recent Mpox outbreak has been concentrated and will evaluate the safety, tolerability, and efficacy of NV-387 in combination with standard of care.
NanoViricides has received preliminary approval from the regional Ethics Committee and is working with a contract research organization to finalize trial design.
Zacks analysts highlighted that NV-387 has shown preclinical activity against a broad range of viruses, including respiratory syncytial virus, influenza, measles, and orthopoxviruses such as smallpox. “Positive data from the Mpox trial would also support the potential use of NV-387 as a smallpox therapy,” the analysts wrote, noting potential collaboration with the US Biomedical Advanced Research and Development Authority (BARDA).
The company is also planning a novel “basket-type” adaptive clinical trial in India to test NV-387 as an empiric therapy against multiple respiratory viruses before the specific causative agent is identified. Preclinical studies suggest NV-387 compares favorably with existing antiviral treatments, such as ribavirin for RSV and oseltamivir for influenza, with improved survival outcomes in animal models.
Zacks valued NanoViricides at $7 per share using a probability-adjusted discounted cash flow model that factors in potential future revenues from NV-387 for Mpox, smallpox stockpiling, and viral respiratory illnesses.
NanoViricides previously demonstrated NV-387 is safe and well-tolerated in a Phase 1 study in India, but human efficacy has yet to be established. The company aims to file a Clinical Trial Application by the fourth quarter of 2025 and estimates the Phase 2 trial will take three to six months to complete, depending on patient enrollment and the outbreak’s course.