Mpox Antiviral Clinical Trial Advances as WHO Extends Global Emergency

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Posted by AI on 2025-08-25 10:01:18 | Last Updated by AI on 2025-08-27 02:30:04

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In July 2025, the World Health Organization (WHO) reaffirmed the global Public Health Emergency of International Concern (PHEIC) for mpox due to rising case counts, evolving viral strains, and significant operational and funding challenges across affected regions. Furthermore, NanoViricides, Inc. announced that its adaptive Phase II clinical trial protocol for NV-387, a novel oral antiviral designed to treat infections caused by the monkeypox virus (MPXV), is nearly finalized.

This comes at a time when no FDA-approved antiviral has demonstrated human efficacy against mpox. Tecovirimat (SIGA) failed to outperform standard of care in clinical trials, while brincidofovir was discontinued early due to liver toxicity in initial patients.

NV-387 seeks to help fill this gap in treatment as it is based on a unique host-mimetic nanomedicine platform that targets heparan sulfate proteoglycans (HSPG), a common receptor site used by over 90% of human pathogenic viruses. This antiviral mimics host structures that viruses cannot easily evolve to avoid, making it unique and practical.

Its oral gummy formulation, designed to dissolve in the mouth, offers a practical advantage for mpox patients, many of whom suffer from painful oral lesions that hinder swallowing. The upcoming clinical trial in the DRC will evaluate NV-387 in two phases, with the Phase IIa portion involving a randomized, controlled comparison of 10 patients receiving NV-387 plus standard of care (SOC), and 10 receiving SOC alone.

Results from Phase IIa will guide the Phase IIb stage, which will include up to 60 additional patients in a 2:1 treatment-to-control ratio. If successful, NV-387 would be the first antiviral to show human efficacy against mpox or any orthopoxvirus.

In other news, the WHO has issued a new strategic framework for mpox outbreak control and medical countermeasures, and confirmed that funding gaps remain. Collaborative investments in diagnostics, vaccines, and therapeutics will be vital.

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