WHO Extended Global Emergency Status of MPox Epidemic – Development of Treatment for MPox with NV-387 is Timely
July 16, 2025
With the World Health Organization extending mpox’s public health emergency status in July 2025, NanoViricides, Inc. reaffirmed the importance of its candidate NV-387. Positioned as a broad-spectrum, host-mimetic antiviral, NV-387 is designed to block viral entry by mimicking human cell receptors, potentially limiting viral escape through mutation. Unlike prior antivirals like tecovirimat or brincidofovir, which have shown limited efficacy or adverse effects in mpox patients, NV-387 showed strong safety signals in Phase I trials. NanoViricides plans to launch a Phase II trial in Africa to assess dosing and efficacy. Success could unlock broader pandemic preparedness and bioterrorism market opportunities.
Following the World Health Organization’s July 2025 extension of the mpox Public Health Emergency of International Concern (PHEIC), NanoViricides, Inc. reiterated the urgency of advancing NV-387, its investigational antiviral designed to treat orthopoxvirus infections, including mpox. NV-387, a novel nanomedicine, operates through a host-mimetic mechanism that targets the conserved viral binding site on heparan sulfate proteoglycans (HSPG), a common viral entry point used by over 90% of human viruses. This strategy aims to limit the potential for resistance due to viral mutation—an issue that has hindered efficacy of existing antivirals like tecovirimat and brincidofovir.
While tecovirimat failed to demonstrate clinical superiority in mpox patients, and brincidofovir caused liver toxicity in early trials, NV-387 has shown favorable safety data in both animal models and a completed Phase I trial, with no adverse events reported. The company now plans a randomized Phase II trial in Africa targeting Clade Ia and Ib infections. The study will assess dosing, safety, and antiviral efficacy of NV-387, formulated as orally dissolvable gummies to accommodate patients with oral lesions, a common mpox symptom.
The strategic implications extend beyond mpox. A successful Phase II trial could position NV-387 as a candidate for stockpiling in national bioterrorism preparedness programs, given that smallpox—another orthopoxvirus—remains a bioterror threat. Tecovirimat and brincidofovir were previously stockpiled under such initiatives, but have shown limited clinical effectiveness in mpox, potentially creating a void for safer and more effective options.
With mpox continuing to spread across Africa and sporadic Clade I cases appearing globally, NV-387 represents a potentially vital countermeasure. If proven effective, it could fill a critical therapeutic gap in current global response efforts and reshape antiviral preparedness for orthopoxvirus outbreaks.