NanoViricides (NYSE-A:NNVC) said on Wednesday it has completed manufacturing of its NV-387 oral drug product, clearing a key step toward dosing patients in an upcoming clinical trial for mpox.
The clinical-stage antiviral drug developer said the drug product, formulated as “NV-387 Oral Gummies,” is ready for use once clinical trial sites are prepared to begin patient dosing.
NV-387, the company’s lead clinical-stage candidate, has received approval from the Democratic Republic of Congo’s regulatory agency ACOREP to enter a Phase II clinical trial for the treatment of mpox.
The oral antiviral previously completed a Phase I clinical trial in healthy volunteers with no reported adverse events or participant dropouts, the company said, indicating strong safety and tolerability.
NanoViricides said NV-387 is designed as a broad-spectrum antiviral therapy targeting multiple respiratory and viral infections, including respiratory syncytial virus (RSV), influenza, coronaviruses including COVID-19, measles and orthopox viruses such as mpox and smallpox.
The company said the drug is based on its proprietary nanoviricide platform, which works by mimicking the surface of human cells to attract viruses. Once the virus binds to the nanoviricide particle, the compound is designed to engulf and neutralize the virus, preventing it from infecting cells.
NanoViricides said the mechanism, which it calls “re-infection inhibition,” could allow its antiviral candidates to maintain activity even as viruses mutate, because the drugs mimic the host cell features viruses rely on to infect.
Separately, the company said president and executive chairman Anil Diwan will present an update on NanoViricides’ programs at the National Investment Banking Association’s 152nd Investment Conference in Fort Lauderdale, Florida on March 12, where he will also meet with investors.