NanoViricides (NYSE-A:NNVC) has a platform that shows a versatile and effective approach to antiviral therapy, with potential applications that target a broad spectrum of viral diseases.
The clinical stage company, pioneering nanomedicine for antiviral therapy, is making significant strides in its fight against viral infections.
The company's proprietary nanoviricide technology involves specially designed nanomachines programmed to attack and dismantle enveloped virus particles. Their lead drug candidate, NV-CoV-2, is undergoing Phase 1a/1b human clinical trials for the treatment of COVID caused by the SARS-CoV-2 coronavirus.
Phase 1a/1b clinical trial results for its lead candidate NV-CoV-2 in healthy volunteer subjects have demonstrated excellent safety in terms of clinical observations.
This has importance not only for COVID but also for the treatment of many other respiratory viral infections. This is because the active pharmaceutical ingredient NV-387 in the drug NV-CoV-2 has demonstrated effectiveness not only against COVID but also against respiratory syncytial virus (RSV) and even ectromelia virus, a mouse model for Smallpox drug development. Additionally, NanoViricides (NYSE-A:NNVC) is developing NV-HHV-1 for the treatment of shingles.
A promising approach in the fight against viral infections
So what is a nanoviricide? Described as biomimetic technology, NanoViricides (NYSE-A:NNVC) trick viruses into attaching to the antiviral nanomachines. Once attached, the nanoviricides wrap around and neutralize the virus, providing a unique mechanism of action without relying on the immune system.
In a recent update, Dr Anil Diwan, president and executive chairman of NanoViricides, shared positive outcomes from the completed Phase 1a/1b clinical trials of NV-CoV-2. The drug, containing NV-387, demonstrated excellent safety and tolerability, paving the way for further development. The company is now focused on advancing NV-CoV-2 through Phase II/III clinical trials.
The Phase 1 trial addressed two different formulations, syrup and gummies, both taken orally. “The gummies have the advantage that it's not a tablet, so there is no swallowing problem. It just simply dissolves in your mouth,” Diwan told Proactive. “So that can be taken by anybody. And oral syrup, of course, allows you to titrate by body weight, which is important for pediatrics.”
Both of the formulations are “very safe,” Diwan said.
“The safety is consistent with our preclinical datasets of safety,” he added. “The drug was found to be non-immunogenic, non-allergenic, non-geno-toxic, and non-mutagenic…In addition, this drug has a very flat pharmacokinetic profile, which means that when the drug is given into the body, whether orally or by injection, there is a sustained plateau of drug concentration that happens. That means it will stay over the drug level for effectiveness for a long period of time.”
NV-387 possesses favorable characteristics for development in treating antiviral diseases, enabling a once-a-day dosing schedule which is desirable for convenience and effectiveness.
While NV-387 was developed during the COVID-19 pandemic, Nanoviricides had always anticipated that the drug would treat several respiratory diseases. Moreover, NanoViricides is exploring the broad potential of its nanoviricides platform, with successful preclinical results against various viruses, including Herpesviruses (HSV-1, HSV-2, VZV – the chickenpox and shingles virus), HIV/AIDS, influenza, and more. The technology's design, based on TheraCour nanomedicine, provides specific targeting mechanisms for diverse viral diseases.
Advanced treatment strategies
As the company looks to the future, Diwan highlighted their commitment to addressing respiratory diseases beyond COVID, including RSV. The potential market for therapeutics for RSV alone is estimated at $8 to $20 billion.
The broad-spectrum nature of NanoViricides' approach, designed to mimic host cell signatures, aims to provide a resilient solution against evolving viruses, making escape of virus from the drug unlikely. This is because even as a virus evolves, generating variants, it continues to use the same host-side signature to cause infection and gain cell entry.
The next step involves the completion of the two-part clinical trial. Moving forward to the Phase 1b, the company has obtained permission to conduct a clinical trial involving COVID patients. However, this part is pending due to the recent drop in global COVID cases, including areas in India, Diwan said. “Efforts are underway to navigate this situation and ensure continuity,” he added. “In the event of challenges, we have the option to close the healthy subjects part independently, with the report on healthy subjects to be prepared for submission.”
Additionally, the company’s endeavors include advancing NV-387 against RSV, ongoing work on influenza viruses, and exploration of the efficacy of NV-387 against ectromelia virus—a smallpox-like model in mice, validated for pursuing the animal rule to advance smallpox drug development towards regulatory approval.
With everything falling into place, NanoViricides has every reason to be optimistic about the versatility and effectiveness of its nanoviricides platform in the ongoing battle against viral infections.