NanoViricides' NV-387 Advances to Phase II Clinical Trials for MPox Treatment
Key Insights
NanoViricides has engaged a CRO to initiate a Phase II clinical trial for NV-387, a broad-spectrum antiviral drug.
The trial will assess NV-387's effectiveness in treating MPox (search) patients amidst a regional pandemic in Africa.
NV-387 has demonstrated strong antiviral activity against orthopoxviruses in animal models, showing potential against MPox (search) and Smallpox (search).
NanoViricides, Inc. (NYSE American:NNVC) has announced the engagement of a Clinical Research Organization (CRO) to conduct a Phase II clinical trial for its broad-spectrum antiviral drug, NV-387. This trial aims to evaluate the drug's effectiveness in treating patients infected with the human MPox (search) virus (hMPXV), which causes MPox disease.
The development of NV-387 is particularly significant given the current lack of approved treatments for MPox (search), which has caused a regional pandemic in several African countries, including the Democratic Republic of Congo and Uganda. The World Health Organization (WHO) declared MPox a Public Health Emergency of International Concern on August 14, 2024, underscoring the urgent need for effective therapeutic interventions.
Addressing Unmet Needs in MPox Treatment
Anil R. Diwan, Ph.D., President and Executive Chairman of NanoViricides, stated that NV-387 is "poised to cause a revolution in treatment of viral diseases, just as antibiotics revolutionized the treatment of bacterial diseases." This optimism is rooted in the drug's novel mechanism of action and promising preclinical results.
Currently, there is no specific drug available for treating hMPXV infections. A clinical trial of tecovirimat (TPOXX®, SIGA) failed to demonstrate any effectiveness over placebo, according to a NIH press release on August 15, 2024. Despite this, the U.S. government has invested significantly in tecovirimat, highlighting the pressing need for effective antiviral drugs.
NV-387: A Novel Approach to Viral Infections
NV-387 has demonstrated strong antiviral activity against orthopoxviruses in animal models, which are considered predictive of potential effectiveness against MPox (search) and Smallpox (search) viruses. Notably, NV-387's effectiveness matched that of tecovirimat in two different models of infection: direct skin infection and direct lung infection.
A key advantage of NV-387 is its mechanism of action, which is designed to prevent viral escape. While viruses can develop resistance to tecovirimat through single point mutations in the viral protein VP-37 (search), NV-387 mimics sulfated proteoglycans, such as HSPG (search), which viruses use as "attachment receptors" to infect cells. This host-mimetic approach makes it highly unlikely for viruses to escape NV-387, as they continue to rely on these attachment receptors regardless of mutations.
Preclinical Evidence and Broad-Spectrum Potential
In addition to its potential against MPox (search), NV-387 has shown promise against other viral infections. It has been found to cure lethally RSV (search)-infected mice and was significantly superior to oseltamivir (Tamiflu®), baloxavir (Xofluza®), and premivir (Rapivab®) in a lethal Influenza (search) lung infection model.
NanoViricides is also developing NV-387 as a treatment for RSV (search), COVID (search), Long COVID, Influenza (search), and other respiratory viral infections, as well as MPOX (search)/Smallpox (search) infections. The company's other advanced drug candidate is NV-HHV-1 for the treatment of Shingles.
About NanoViricides
NanoViricides, Inc. is a clinical-stage company focused on creating special-purpose nanomaterials for antiviral therapy. Their nanoviricide technology is based on intellectual property licensed from TheraCour Pharma, Inc. The company's business model involves licensing technology for specific application verticals of specific viruses.