NanoViricides (NYSE-A:NNVC) is preparing to launch a Phase 2 clinical trial of its lead antiviral candidate NV-387 for the treatment of Mpox Clade I in the Democratic Republic of Congo (DRC), following ethics approval from the country’s health ministry in May, according to a research note by Zacks Small Cap Research.
The trial will test the efficacy and safety of NV-387, a broad-spectrum antiviral developed using NanoViricides’ proprietary nanomedicine platform, in up to 80 hospitalized patients.
NV-387 has shown preclinical activity against multiple viruses, including SARS-CoV-2, influenza, RSV, and Mpox.
The candidate completed Phase 1 trials in India in 2024 without reported adverse events, supporting further clinical development.
Zacks analysts said the approval in the DRC "positions NanoViricides at the forefront of developing urgently needed antiviral treatments for one of the world’s most concerning re-emerging infectious diseases."
NanoViricides' core technology uses a bio-mimetic approach, creating compounds that mimic human cell receptors, which many viruses use to enter host cells. “Since over 90% of human pathogenic viruses use a similar first attachment point to gain entry into human cells (Heparan SPGs), a single drug like NV-387 can potentially target many,” analysts wrote.
The Phase 2 trial will be conducted in two stages. The initial Phase 2a portion will treat 20 patients to assess safety and determine dosing duration, followed by a randomized Phase 2b involving 60 additional patients to evaluate efficacy endpoints such as lesion recovery, rash elimination, and viral load. The company expects to file its Clinical Trial Application (CTA) in August and begin the trial by the fourth quarter of 2025.
According to Zacks, “The treatment of MPox represents a substantial opportunity for NanoViricides as it looks to validate its lead development candidate NV-387 as a next-generation antiviral therapy.”
NanoViricides is targeting Mpox Clade I, the more lethal form of the virus, which has a historical case fatality rate of 10.6%. Existing antivirals like tecovirimat and brincidofovir have shown little or no clinical benefit in recent studies. “These results show that tecovirimat is not an effective treatment for MPox infections,” analysts noted, referring to recent trial data from the DRC and the US.
The Mpox outbreak in the DRC offers a viable patient population for timely recruitment, and trial costs in the region are relatively low. Beyond the immediate goal of clinical validation, success in Mpox could unlock broader value. “Proof of efficacy for NV-387 in MPox would validate the company’s animal model data and establish that those data are predictive of clinical outcomes,” analysts said.
Zacks also pointed to potential government procurement opportunities if NV-387 proves successful. “Were NV-387 shown to be effective against MPox, it could present an opportunity for that drug to be tested for use in bioterrorism readiness and potentially to be included in the SNS.”
Zacks noted that SIGA Technologies, which produces the smallpox antiviral tecovirimat (TPOXX), signed a multiyear contract with the U.S. government worth up to $602.5 million. “Thus, we estimate if NV-387 showed efficacy against MPox it could represent a multi-hundred-million-dollar opportunity,” they added.
Topline results from the Phase 2 trial are expected in the first quarter of 2026.