NanoViricides investigating MEURI protocol for using NV-387 to treat MPOX

NanoViricides reports that it is investigating the possibility of using NV-387 for the treatment of MPOX patients under the WHO MEURI protocol, in light of the recent WHO PHEIC declaration for the current 2024 MPOX outbreak that is rapidly spreading into more than ten countries in Africa with additional cases detected in Thailand and Sweden. MEURI, i.e. Monitored Emergency Use of Unregistered and Investigational Interventions, is an ethical protocol developed by the World Health Organization to evaluate the potential use of experimental drugs in the event of public health emergencies. The Company believes that the MEURI protocol may be applicable for the evaluation of NV-387 for the treatment of MPOX infection in patients. NV-387 has completed Phase I clinical trial for safety and tolerability studies in healthy subjects with no adverse events reported indicating excellent safety and tolerability. NV-387 has demonstrated strong improvement in survival in animal model studies matching that of the currently approved drug, tecovirimat, indicating excellent effectiveness. MPOX Clade 1/1b require development of new therapeutics due to limitations of existing therapies. Additionally, the Company has also found that NV-387 was superior to or equivalent to existing drugs in non-clinical animal trials in the case of three major classes of respiratory viruses: RSV, Influenza, and COVID; the so-called “triple-demic” respiratory viruses. The Company believes that NV-387, as a single broad-spectrum antiviral drug that can treat a large number of viruses, could be as revolutionary for the treatment of viral infections as penicillin was to bacterial infections, when its effectiveness is proven in human clinical trials. NV-387, the Company’s novel broad-spectrum antiviral treatment was found in an animal model study emulating the direct skin infection by the virus to be as effective as the current approved drug tecovirimat. Direct skin infection is thought to be the major mode of transmission of the MPOX virus in the current epidemic of MPOX Clade 1 and Clade 1b, just as it was found to be the main mode of transmission in the 2022 MPOX epidemic of Clade 2. In this lethal animal model virus infection study, oral treatment with NV-387 led to the same extent of increase in survival as oral treatment with tecovirimat. Additionally, treatment with the Company’s formulation containing both NV-387 and tecovirimat, called NV-387-m-T, led to a much greater improvement in survival than either NV-387 or tecovirimat. Increase in survival is a quantitative indicator of effectiveness of the treatment in this model. In this study, mice were lethally infected with the ectromelia virus, intradigitally by scoring skin on footpads. This model emulates direct infection of the virus by skin abrasion. It is believed that direct skin-to-skin contact is the dominant mode of transmission of MPOX in the current 2024 MPOX Clade 1/1b global public health emergency, as it was in the 2022 MPOX Clade 2 epidemic. Mice in different groups were were treated orally with tecovirimat, NV-387, or NV-387-m-T, or vehicle. Ectromelia virus is in the same class as smallpox and mpox viruses, and has been used as a validated model for orthopoxvirus drug development. NV-387 acts by a novel mechanism that the Company calls “Re-Infection Inhibition”, meaning the drug blocks the virus from being able to infect cells in the first place, a mechanism which is distinctly different from that of neutralizing antibodies or entry inhibitors. Tecovirimat, on the other hand, inhibits the release of the virus particles after they have already made thousands of copies in a cell. These mechanisms are complimentary to each other, leading to enhanced effect when both drugs are used simultaneously. The Company developed a special oral formulation for being able to deliver both drugs simultaneously, called NV-387-m-T.