As cases of the monkeypox virus continue to grow, the race is on for a way to fight this once-rare disease.
Since the first reports of monkeypox infection in the United States started popping up in May, cases have now been reported in all 50 states for a total of over 23,000 new infections.
In response to that rapid spread, NanoViricides Inc. (NYSEAMERICAN: NNVC) wants to speed up the timeline on the development of its novel antiviral platform to treat the monkeypox virus. Here’s the company’s plan for bringing its monkeypox drug development platform to clinical trials sooner.
NanoViricides’s Rapid Drug Development Program For Monkeypox Antiviral
Having already begun drug development of NV-387-T, its monkeypox drug candidate, NanoViricides reports that it’s optimistic it can speed up the process to move the antiviral into human clinical trials quickly.
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.
That COVID-19 antiviral (NV-387) has already gone through preclinical development and NanoViricides is already working to initiate clinical trials of the drug candidate, so all of that data could be used to meet the safety and toxicology requirements for an investigational new drug (IND) application of NV-387-T for monkeypox with the FDA.
NanoViricides’s NV-387-T Could Offer More Effective, More Practical Monkeypox Treatment
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.
As the company works to speed up development and move its novel Monkeypox antiviral into human clinical trials quickly, it hopes to be able to offer a safer, more effective treatment to combat this outbreak as soon as possible.
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. In addition, we are developing a clinical candidate for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. The Company cannot project an exact date for filing an IND for this drug because of its dependence on a number of external collaborators and consultants.The Company is now working on tasks for completing an IND application. The Company is currently pursuing two separate drug candidates for the treatment of COVID-19 patients. NV-CoV-2 is our nanoviricide drug candidate that does not encapsulate Remdesivir. NV-CoV-2-R is our other drug candidate that is made up of NV-CoV-2 with Remdesivir encapsulated in it. The Company believes that since Remdesivir is already US FDA approved, our drug candidate encapsulating Remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.The Company intends to re-engage into an IND application to the US FDA for NV-HHV-101 drug candidate for the treatment of shingles once its COVID-19 project moves into clinical trials, based on resources availability. The NV-HHV-101 program was slowed down because of the effects of recent COVID-19 restrictions, and re-prioritization for COVID-19 drug development work.The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for poxviruses if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
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