NanoViricides Begins Phase II Trial of Broad-Spectrum Antiviral NV-387 in Mpox in DRC
核心洞察
NanoViricides has begun a Phase II trial of its broad-spectrum antiviral NV-387 in mpox (搜索), with the first patients enrolled at Lodja in Sankuru province, Democratic Republic of Congo.
The adaptive, multi-center, randomized, open-label Phase IIa/IIb study compares oral NV-387 gummies against standard of care in patients with confirmed or presumptive hMPXV infection.
No drug is approved for mpox (搜索), and tecovirimat previously failed to show efficacy against both Clade I and Clade II, while brincidofovir carries dose-limiting liver and gastrointestinal toxicity.
NanoViricides has begun a Phase II clinical trial of its broad-spectrum antiviral drug NV-387 as a treatment for monkeypox virus infection, with the first patients enrolled in the Democratic Republic of Congo. The trial is registered in the Pan African Clinical Trials Registry under identification number PACTR202609506749917.
The study is titled "An adaptive international, multi-center, randomized, open-label, interventional, parallel group, phase II (IIa and IIb) clinical trial to evaluate the efficacy and safety of a new chemical entity NV-387 formulated as oral gummies in comparison to standard of care, administered in patients with clinical signs of mpox (搜索) disease and laboratory confirmed or presumptive hmpxv infection."
The trial is being conducted at Lodja in Sankuru province, a remote and resource-poor region where mpox (搜索) cases continue to occur. NanoViricides said setting up the clinical sites required several months of effort because of resource limitations at the hospital. The province is not currently an Ebola-affected region.
Trial Leadership and Site Setup
The principal investigator is Prof. Vivi Maketa Tevuzula, MD, MSc, PhD, a professor in the Department of Tropical Medicine at the University of Kinshasa and principal investigator at the Institut Multisectoriel pour l'Amélioration du Bien-être (IMABE) in Kinshasa. Her research focuses on infectious diseases, including clinical trials of novel drugs and studies of vaccine safety, immunogenicity and efficacy, as well as health systems research in resource-limited settings. She has served as principal investigator on multiple international studies of malaria, mpox (搜索) and vaccine-preventable diseases, and leads interdisciplinary work on genomic surveillance and One Health approaches. The Bayer Foundation awarded her its Early Excellence in Science Award 2023 in Medical Science.
"We are pleased to have Professor Maketa lead this clinical trial," said Anil R. Diwan, PhD, president and executive chairman of NanoViricides. "This is the very first Phase II clinical trial of the broad-spectrum antiviral drug NV-387 and aims to explore its safety and effectiveness in Mpox (搜索)."
Professor Maketa's team is already on site in the DRC, as is the team from the company's contract research organization, Om Sai Clinical Research Pvt. Ltd. of India.
An Unmet Need in Mpox
There is no approved drug for mpox (搜索). Clinical trials of tecovirimat (TPOXX, SIGA) previously failed to demonstrate efficacy against both mpox Clade II and Clade I. Tecovirimat was approved by the US FDA for smallpox (搜索) under the Animal Rule provision.
A pan-African trial called MOSA of brincidofovir, also approved by the FDA for smallpox (搜索) under the Animal Rule, started in January 2025 and is ongoing. As of January 2026, the study's Data Safety and Monitoring Board did not identify any new safety concern after the first 50 patients were randomized, and the trial plans to enroll a further 50 patients in the first half of 2026 to perform an interim efficacy analysis. According to its prescribing information, brincidofovir (TEMBEXA) carries a black box warning and warnings for elevations in hepatic transaminases and bilirubin, and for diarrhea and other gastrointestinal adverse events; administration must be performed under physician care with continuous evaluation of liver toxicity.
Mpox (搜索) Clade I is endemic in the DRC, and all cases in the trial are expected to be of the Clade I virus. Clade II is substantially less severe. In the United States, Clade II has become endemic and circulates at low levels, primarily affecting men who have sex with men through transmission during sexual activity. According to the CDC, from 2023 to 2025 about 1,700 to 2,800 Clade II cases were confirmed in the US, with transmission occurring via skin abrasions.
Clade I cases in the US have been slowly increasing. As of August 27, 2026, more than 50 confirmed Clade I cases had been reported since November 2024, all in travelers to mpox (搜索)-manifesting countries or regions or their contacts, according to the CDC. Community spread is likely occurring, with three Clade I cases in California in unconnected persons with no travel to Africa, though the CDC assesses the potential for a widespread outbreak as low.
Vaccine Limits and Stockpile Considerations
Jynneos, a vaccine originally developed for smallpox (搜索), is in use to prevent mpox (搜索), primarily in Clade II contacts. Its immune protection was found to wane rapidly in a clinical study, and its effectiveness is limited, at 36 percent for one dose and 66 percent for two doses against the less pathogenic Clade II, according to a 2023 New England Journal of Medicine analysis by the CDC's Mpox Emergency Response Team. NanoViricides states that effectiveness is likely to be much less against the more severe Clade I, and that vaccines do not protect in the first few weeks, limiting their usefulness during a pandemic.
The company argues that the two drugs in the US Strategic National Stockpile, TPOXX and TEMBEXA, would be unsuitable for pandemic response if Clade I spreads. It notes that although both are approved for smallpox (搜索) under the FDA animal rule, the clinical failure of tecovirimat against the less severe and far less lethal mpox (搜索) raises questions about its possible utility in a smallpox bioterrorism event, and that brincidofovir's known toxicity profile makes it unsuitable for wide-scale deployment in a large outbreak. US government stockpiling contracts for the existing smallpox drugs have been in the several hundreds of millions of dollars, which the company describes as an equivalent potential opportunity for NV-387.
Mechanism and Preclinical Data
NV-387 is a host-mimetic, direct-acting antiviral designed to mimic human cells. According to Diwan, the drug "is designed to mimic human cells to trap and destroy the virus," and "this single drug can target over 90-95% of human pathogenic viruses due to this biomimicry."
The compound displays ligands that mimic sulfated proteoglycans (搜索) such as HSPG, the attachment receptor viruses use to cause cell infection, enticing the virus to bind to and become engulfed by the drug's polymeric micelle. Because viruses continue to use sulfated proteoglycans regardless of field changes, the company states that escape from NV-387 is highly unlikely, in contrast to vaccines, antibodies and small chemical drugs such as tecovirimat, oseltamivir (Tamiflu) and baloxavir (Xofluza), which viruses readily escape through small changes. Escape from tecovirimat is known to occur by a single point mutation in the viral protein VP-37 (搜索).
In an animal model considered important for establishing potential effectiveness against mpox (搜索) and smallpox (搜索), NV-387 showed strong antiviral activity against an orthopoxvirus. Its effectiveness matched that of tecovirimat in two infection models, one by direct skin infection and one by direct lung infection.
Regulatory Path
Mpox (搜索) is an orphan disease in the US, and NanoViricides has applied to the FDA for Orphan Drug Designation for NV-387 in its treatment. If granted, the designation would enable frequent meetings with the FDA, waiver of certain FDA fees, certain R&D credits and an extension of marketing exclusivity once approved. The company estimates the economic impact of these benefits in the range of tens of millions of dollars.
NV-387 is the company's lead candidate, with planned development in RSV, COVID, Long COVID, influenza and other respiratory viral infections as well as mpox (搜索) and smallpox (搜索). Its other advanced candidate is NV-HHV-1 for shingles. NanoViricides is a clinical-stage company developing nanomaterials for antiviral therapy based on the nanoviricide class of drug candidates, using technology licensed from TheraCour Pharma (搜索), Inc.