From COVID-19 surges to increases in RSV and influenza cases, viral infections and diseases are on the rise, with no end in sight. Finding a way to effectively fight them let alone stop them in their tracks has proven elusive. That could change thanks to NanoViricides, Inc. NNVC, the clinical-stage drug company developing nanomedicine drugs to fight viruses including COVID-19, RSV, shingles and many more. The company is proving its mettle in revolutionizing the antiviral infections landscape, just as antibiotics like penicillin revolutionized the treatment of bacterial infections.
That was on display last year. NanoViricides hit several milestones with its nanoviricide active pharmaceutical ingredient NV-387. NV-387 – which the drug company is developing to fight COVID-19, RSV and other viral illnesses. It blocks the reinfection cycle of the viral disease, binding and fusing with the virus surface, uprooting the glycoproteins required for the virus to bind to the human cell and rendering it incapable of infecting a cell. The company thinks NV-387 is more effective than antibodies, which can only cover the virus and not destroy it. Through clinical trials the company reports demonstrating the strong safety and tolerability of NV-CoV-2 oral drug products that include NV-387, which have implications beyond COVID – setting it up for what it expects to be long-term success and growth. In late January the company announced the Healthy Subjects Part of the Clinical Trial was completed successfully with all subjects discharged. There were no discontinuations and all dosage levels at all dosing instances were well tolerated. What’s more, there were no adverse events. NV-387 was found to be safe for both single dosing and for repeat dosing, according to the company.
“We believe that the strong demonstration of safety and tolerability in the clinical trial sets NV-387 on a path of long-term success against many viruses,” said Dr. Anil R. Diwan, President, Executive Chairman, co-founder and co-inventor. “We believe nanoviricides platform is now on a solid footing to revolutionize treatment of antiviral infections just as antibiotics like penicillin revolutionized treatment of bacterial infections.”
NV-387 Revolutionary Edge
What sets NV-387 apart from other drugs on the market and makes it so promising is its ability to bind and stop the infection regardless of how much the virus changes. This is because NV-387 mimics the host-side features that the virus requires to execute its infection plan that do not change even as the virus mutates. That means that NV-387 and other antiviral drugs designed on the company’s platform should maintain a long, useful product life – potentially lasting several decades – similar to antibiotics but very different from the current approaches to treating viral diseases. It solves the biggest problem with antiviral treatments available today: viruses escaping vaccines, antibodies and small chemical drugs.
Furthermore, NV-387 is developed to work against a large number of viruses, potentially positioning the company to go after several large market opportunities beyond COVID from RSV to smallpox, with the same drug. As it stands, there is no safe drug for the treatment of RSV infection, which makes NV-387 a candidate to capture a large part of what is forecast to be a $8.73 billion market by 2031, growing at a CAGR of 18.9% from 2023 until then.
There are a number of antiviral drugs on the market, but each is specific to a particular virus, and substantially all of them are susceptible to viral mutations, allowing the virus to escape the drug. So the ability of NV-387 to go after many distinctly different virus families and not allow virus escape set it apart, potentially opening a new era in how we treat viral infections and prepare for future pandemics.
Added to that there is the reported strong safety of NV-387, which was demonstrated in clinical trials last year. NV-387 is the active ingredient in NV-CoV-2, a drug product NanoViricides made into two oral formulations: NV-CoV-2 Oral Syrup and NV-CoV-2 Oral gummies. Last year, the company kicked off phase 1 human clinical trials of the two drugs in India with Karveer Meditech Pvt. Ltd., NanoViricides’ licensee and collaborator, which also has the rights to develop and commercialize the drugs in India.
Of the 36 healthy human subjects who participated in the trial, all completed it with no adverse or serious adverse events reported. That indicates both of the formulations are safe in humans in repeated dosings. This is consistent with the company’s preclinical safety/toxicology animal studies, the company said when announcing results.
NV-387 may turn out to be the only COVID-19-fighting drug with a safety profile strong enough to give it to all patient populations, according to the company. In contrast, currently available COVID drugs have strong limitations on the patient populations that they can be used in.
If that proves true, it would be game-changing for NanoViricides because these safety data also apply to other viral indications for NV-387, including RSV and Smallpox. RSV is a common disease primarily in infants, young children, older persons and immunocompromised persons.
NV-387 Use Cases Growing
NanoViricides is also testing NV-387 for MPox and Smallpox viruses and in an animal model found it to be highly effective. It has also shown strong activity against RSV. It doesn’t hurt that NanoViricides believes NV-387 is capable of encapsulating and delivering other drugs in a targeted manner and improving the pharmacokinetics/pharmacodynamics of the guest drug by protecting it from bodily metabolism. That means NV-387 can find its way into other drugs, including oral ones, which would create yet another revenue stream. The ability to encapsulate drugs with NV-387 was already demonstrated for Remdesivir, as well as prodrugs of Remdesivir and Ribavirin, according to the company. The company has already published peer-reviewed papers in scientific journals on these aspects.
The company ended 2023 with cash and cash equivalent of about $5.31 million and additional agreements have added $2.5 million to its available cash horde, bringing the total to about $7.8 million, which NanoViricides says is enough to continue clinical trials. The company reported that it expects clinical trial expenditures to continue to rise as clinical trials for NV-CoV-2 progress. However, it was able to keep its cash burn for the past six months under $3 million. NanoViricides shares that it has consistently maintained a frugal operation with a focus on creating a high value for investor money.
More Drug Candidates In The Works
In addition to its drug to fight COVID, RSV and orthopoxviruses, the company has drug candidates in development against influenza (including bird flu), HIV, dengue, Ebola/Marburg and other viruses at different preclinical stages. In many of the programs, NanoViricides has already proven animal model effectiveness and preliminary safety and is ready for candidate optimization and clinical candidate selection studies. These programs combined boast a market size of $40 to $70 billion, according to NanoViricides.
Put together, NanoViricides is optimistic about its prospects to revolutionize how we treat viral diseases. While the COVID-19 pandemic may be over, new variants of the virus are still emerging, underscoring the need for better drugs to fight this virus. Then there is the potential of another pandemic that scientists at the World Health Organization are warning may be 20 times worse than COVID-19. Add RSV, shingles, bird flu and a host of other viruses to the mix, and it’s easy to see why NanoViricides believes it’s poised for growth this year and beyond.
Featured photo by LightField Studios on Shutterstock.
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