NanoViricides says made ‘significant progress’ in NV-387 regulatory advancement

The company said, “We have made significant progress in the regulatory advancement of NV-387. A Phase Ia/Ib clinical trial in healthy subjects was completed with all subjects discharged as of end of December, 2023. There were no adverse events reported. Lab data analysis is currently being conducted. We are awaiting a final report. Additionally, we have made significant progress in expanding the indications of NV-387, that would result in substantial improvement in the return on investment when regulatory approvals are obtained. Our host-mimetic, direct-acting, broad-spectrum, antiviral agent. NV-387 was found to have activity that surpassed the activity of known agents in lethal virus infection animal model trials for COVID, RSV, and Influenza. In fact, we found that NV-387 treatment possibly completely cured the lethal RSV infection in mice, based on indefinite survival of the animals with no lung pathology. There is currently no treatment for RSV infection. In particular, pediatric RSV infection treatment is an unmet medical need that we believe is of critical importance. Pediatric RSV treatment itself is expected to be a multi-billion-dollar market in the USA alone. NV-387 treatment was found to be substantially superior to three approved anti-influenza drugs, namely, oseltamivir, peramivir, and baloxavir. Additionally, NV-387 also demonstrated activity against lethal poxvirus infection animal models that was on par with the approved drug tecovirimat. NV-387 acts by a mechanism that is significantly different compared to the tested existing antiviral agents for Influenza and for Poxviruses. This demonstrated broad-spectrum activity of NV-387 against widely varying viruses is because NV-387 is designed to attack the virus particle by mimicking sulfated proteoglycan feature, and all of these viruses are known to utilize heparan sulfate proteoglycans for gaining cell entry. Further, for all of these tested viruses, even as the virus genome changes in the field, NV-387 is expected to continue to be effective, and the virus would be highly unlikely to escape NV-387. This is because despite all of the genomic changes, the virus continues to use HSPG, as is well known. Thus NV-387 solves the greatest problem in antiviral countermeasures; the problem of virus escape. Viruses are known to escape all of the current antiviral tools that include vaccines, antibodies, and small chemical drugs. Thus we anticipate that NV-387 would revolutionize the treatment of viral infections reminiscent of how penicillin revolutionized the treatment of bacterial infections.”