Its reasons for that optimism are twofold. First, the active ingredient tecovirimat has already been approved by the Food and Drug Administration (FDA) as a smallpox treatment. Thanks to the FDA’s recent expanded-access protocol, it’s also already being administered to monkeypox patients in the form of TPOXX, an antiviral infusion manufactured by Catalent Inc. (NYSE:CTLT) and distributed by SIGA Technologies Inc. (NASDAQ:SIGA).

Second, NanoViricides is optimistic that it can use preclinical data from its other drug development programs to support its application for NV-387-T. That’s because the novel component in its monkeypox drug candidate  is NV-387, the same as that  used in NV-CoV-2, the company’s COVID-19 drug candidate. NV-387-T encapsulates the already FDA-approved Tecovirimat (for smallpox) within the belly of the NV-387 polymeric micelles, providing substantial additional benefits. 

The current TPOXX treatment has helped doctors combat the recent monkeypox outbreak, but it also comes with some drawbacks. The formulation is an infusion that takes six hours per dose, making it a time-consuming treatment that must be administered at a hospital. It’s also not safe for patients with severe renal impairment (kidney damage). 

The NV-387-T drug candidate NanoViricides is developing, on the other hand, it would be a 30-minute injection, and the company is also working on an oral version that would eliminate the need for a hospital visit. TPOXX is available as oral capsules which are used in most cases except for severe hospitalized cases at present. NanoViricides believes NV-387-T oral formulation may have substantial advantages in improving the pharmacokinetics and effectiveness of tecovirimat compared to the current TPOXX oral capsules. 

By encapsulating the active ingredient (tecovirimat)  in NanoViricides’s NV-387 platform, the company hopes to make tecovirimat both more effective and safe for patients with kidney damage. In preclinical studies of the company’s COVID-19 drug candidate, NV-387 encapsulation of remdesivir showed improved pharmacokinetics (how well a drug moves through the body) and pharmacodynamics (how the body responds to the drug) compared to Gilead Sciences Inc.’s (NASDAQ:GILD) formulation.

NanoViricides believes that’s because encapsulation prevents the body from metabolizing the drug so it’s able to remain in the system at higher concentrations for longer periods of time. It’s that improved ability to remain in the body that would potentially decrease the risk of kidney toxicity resulting from rapid metabolizing of the drug. And the stability of NV-387 encapsulation compared to the current TPOXX injectable formulation is expected to help reduce infusion time from six hours to 30 minutes.