Adaptive Clinical Protocol Design for Phase II MPox Clade I Treatment with a Novel Broad-Spectrum Drug NV-387
July 14, 2025
NanoViricides, Inc. is preparing to launch a Phase II adaptive clinical trial of its antiviral candidate NV-387 for Clade Ia and Ib mpox, aiming to evaluate safety, dosing, and efficacy. The trial will begin in the Democratic Republic of the Congo and use a dissolvable oral gummy formulation to ease administration in patients with painful lesions. If successful, NV-387 could become the first human-tested antiviral for orthopoxviruses. This trial arrives as existing options like tecovirimat have underperformed, and Clade I mpox remains a growing global concern. Further support and scrutiny will be crucial as the study advances.
NanoViricides, Inc. is advancing NV-387, a host-mimetic nanomedicine designed to treat Clade Ia and Ib mpox infections, into an adaptive Phase II clinical trial in the Democratic Republic of the Congo. This step positions NV-387 as a potentially first-in-class antiviral demonstrated to be effective in human trials against orthopoxviruses. The planned trial includes a Phase IIa dosing and safety evaluation (20 participants) and a Phase IIb efficacy arm (60 participants), with randomization against standard of care.
What sets NV-387 apart is its delivery via an oral gummy formulation—strategically designed to dissolve in the mouth, bypassing swallowing difficulties common among mpox patients with mucosal lesions. If successful, NV-387 could address an urgent therapeutic gap. Existing antivirals like tecovirimat and brincidofovir, while FDA-approved for smallpox via the Animal Rule, have shown disappointing safety or efficacy outcomes in mpox clinical trials.
The company highlights the urgent need for treatment readiness against Clade I mpox variants, which carry higher case fatality rates (up to 11%) and have fueled sustained epidemics in Central Africa. NanoViricides plans to seek regulatory approval not only in the United States but also in Africa and Europe, with the potential to earn orphan drug designation in the U.S.
However, NV-387’s clinical journey remains in its early stages, and as with any first-in-human therapeutic, rigorous scrutiny will be essential. The success of this trial could redefine therapeutic options for mpox and smallpox, especially amid growing concern over bioterrorism and global health security.
As mpox continues to spread and evolve, therapeutic innovation like NV-387 could become a cornerstone of future response strategies. Its success hinges not only on trial outcomes but also on strategic partnerships and global regulatory engagement. The world should watch closely.