NanoViricides (NYSE-A:NNVC) said on Monday it had engaged a clinical research organization to conduct a Phase II trial for its broad-spectrum antiviral drug NV-387.
The Connecticut-based company is targeting NV-387 for the treatment of MPox, a disease caused by the human Mpox virus (hMPXV), which has spurred a regional pandemic in parts of Africa, including the Democratic Republic of Congo and Uganda.
The World Health Organization declared MPox a public health emergency of international concern in August 2024.
"NV-387, our broad-spectrum antiviral drug is poised to cause a revolution in treatment of viral diseases, just as antibiotics revolutionized the treatment of bacterial diseases," said Anil Diwan, president and executive chairman of NanoViricides.
There is no approved treatment for MPox, and the clinical trial failure of tecovirimat (TPOXX), a leading antiviral candidate, has underscored the urgent need for effective therapies. Despite the setback, SIGA Technologies, the maker of TPOXX, secured contracts worth over $120 million from the US government and the Department of Defense in mid-2024 for the drug’s procurement.
"These desperate attempts by the previous US administration to acquire an ineffective drug with hundreds of millions of dollars of taxpayer money only go to show how sorely a truly effective antiviral drug that works against MPox/Smallpox is needed by the government agencies," added Diwan.
NV-387 has demonstrated strong antiviral activity in preclinical studies, matching or exceeding tecovirimat’s effectiveness in animal models simulating skin and lung infections. Unlike tecovirimat, which can be bypassed by a single viral mutation, NV-387 targets the virus’s reliance on host-cell attachment mechanisms, reducing the likelihood of resistance.
NanoViricides highlighted the drug’s versatility, citing its superior performance in a lethal influenza lung infection model compared to established treatments like oseltamivir (Tamiflu) and baloxavir (Xofluza). NV-387 has also shown efficacy in curing respiratory syncytial virus (RSV) infections in animal studies.
The company’s host-mimetic drug design leverages polymeric micelles to mimic cell structures, luring viruses into binding with the drug instead of healthy cells. This mechanism, NanoViricides says, makes NV-387 uniquely suited to address emerging viral threats that often evade vaccines and traditional antiviral drugs.
The upcoming Phase II trial aims to further validate NV-387’s clinical efficacy and safety, potentially positioning the drug as a transformative option in the fight against viral diseases.