NanoViricides (NYSE-A:NNVC) announced it is moving forward with Phase 2 clinical development of its experimental antiviral therapy, NV-387, for the treatment of Mpox.
The company has selected Mpox as the first indication among several viral targets studied in preclinical models, including RSV, influenza, and COVID-19.
NanoViricides said it chose Mpox based on the potential for rapid trial enrollment, cost-effective operations in the Democratic Republic of Congo (DRC), and existing animal data.
The Phase II trial is being developed in coordination with a clinical trial site in the DRC. A protocol has been drafted in collaboration with a principal investigator in the region, and a clinical trial application (CTA) is currently being finalized.
A contract research organization has been engaged to manage the trial and regulatory submissions. Manufacturing of the drug’s active ingredient is nearly complete at the company’s facility, with production of the oral gummy formulation underway.
The company believes the Mpox trial could provide proof of concept for NV-387’s broader antiviral potential. Successful human efficacy data could validate its animal model results and support future development of NV-387 for respiratory viruses, it added.
Mpox remains endemic in parts of Central Africa and has caused occasional outbreaks globally. The strain circulating in the DRC, primarily Clade 1b, has a higher severity than strains seen in recent outbreaks in the West.
NanoViricides noted the trial’s location could facilitate access to patients while keeping costs lower than similar studies in the US or Europe.
The company plans to advance NV-387 in respiratory indications once the Phase 2 trial in Mpox is underway.