- NanoViricides (NNVC, Financial) is advancing its promising antiviral NV-387 to Phase II trials following WHO's extension of MPox global emergency status.
- NV-387 demonstrated no adverse events in Phase I trials and offers an innovative oral gummy formulation, potentially addressing significant treatment gaps.
- The company aims to access a multi-billion-dollar market in bioterrorism preparedness, focusing on the U.S. Strategic National Stockpile contingent on successful Phase II trials.
NanoViricides, Inc. (NNVC) has announced progress in the development of its antiviral drug candidate, NV-387, in response to the World Health Organization's (WHO) extended global emergency status over the ongoing MPox epidemic. Highlighting the urgency of a treatment strategy, NanoViricides is preparing NV-387 for Phase II clinical trials after successful Phase I trials demonstrated the drug's safety and oral availability.
NV-387 is positioned as a potential game-changer for MPox treatment, boasting a unique host-mimetic nanomedicine technology designed to prevent viral escape, unlike existing drugs Tecovirimat and Brincidofovir, which have faced challenges related to effectiveness and safety. In preclinical animal studies, NV-387 achieved a No-Observed-Adverse-Event Level (NOAEL) at 1,200 mg/kg and demonstrated a favorable safety profile in Phase I human trials with no adverse events reported.
The drug's formulation as oral gummies addresses a practical challenge for MPox patients who may have oral lesions, making it difficult to swallow pills or capsules. This innovative delivery method is designed to dissolve in the mouth, providing relief for those affected.
Strategically, NanoViricides targets the expansive bioterrorism preparedness market, particularly focusing on the U.S. Strategic National Stockpile, which has already invested significantly in less effective treatments. With Phase II trials anticipated in the African region, the company aims to capture significant market share following successful outcomes, potentially benefiting its broader pipeline of antiviral programs.
