NanoViricides, Inc. reported that its clinical stage lead nanoviricide broad-spectrum antiviral drug candidate, NV-387, results in an ideal flat blood concentration profile for an extended time period upon oral administration in two different animal models. This unusual but highly desirable, extended flat time profile of blood concentration of orally given NV-387 enables sustained antiviral effect over a long period of time, allowing infrequent dosing regimens. The blood concentration of NV-387 increased to a peak in approximately the first hour, and then remained almost constant for eight hours or longer, thereafter, the concentration declined to reach baseline at about twelve hours; upon oral administration of a first dose of NV-387.

This was found to be the case in studies involving two different animal models, namely, rats and dogs. After repeated dosings, the plateau of the sixth dose lasted for at least 24 hours, thereafter declining to baseline at about 36 hours, in both the rat and dog animal models. The same plateau profile phenomenon was observed in both male and female animals, as well as in both species of animals, namely, rat and dog.

The blood concentration profile of NV-387 is indicative of the formation of a buffering reservoir of the drug in the host that releases the drug at a regular rate into the bloodstream. The Company has recently reported that NV-387, when given as a slow bolus intravenous infusion, was found to result in a relatively flat plateau of blood concentration of the drug with very slow decline over a 24 hour period in a cynomolgus monkey model. The flat time profile of NV-387 indicates that even at very high dosings, its blood concentration is unlikely to result in unwanted side effects.

Typical drugs result in a rapid rise in blood concentration of the drug in generally the first hour to a peak, thereafter rapidly exponentially decreasing to baseline in 3-6 hours. In order to ensure that the concentration of the drug is sufficiently high to provide antiviral effect at say 2-4 hours from dosing, the drug dose chosen would be relatively high, and can therefore result in a substantially greater drug concentration in the beginning, which can result in unwanted side effects. Therefore, a sustained, nearly flat drug concentration profile is highly sought-after.

In the repeat-dose oral NV-387 administration studies in both rat and dog models cited above, two doses were given on the first day (at 0h and 12h), followed by third dose at 24 h, and then daily doses at 24 hour intervals, for a total of six doses in five days. The Company has previously reported that NV-387 when administered orally resulted in strong antiviral effects in several respiratory viruses. In lethal infections with hCoV- NL63 (a model for SARS-CoV-2, cause of COVID), RSV, as well as Influenza A/H3N2, orally administered NV-387 was found to be superior to approved therapeutics where available.

In fact, the Company has found that NV-387 enabled complete cure of RSV infection in the mouse model of lethal lung infection with RSV A2. The Company therefore believes that NV-387 is a first-in-class, broad-spectrum antiviral agent that could be a revolutionary single drug for the treatment of a multitude of respiratory viral infections including RSV, COVID, Influenzas and potentially other viruses. The presented non-clinical studies of pharmacokinetics of orally administered NV-387 provide support that the strong antiviral effect seen in these antiviral animal model efficacy studies is the result of NV-387 circulating in the body and exerting its direct antiviral effects.