SARS-CoV-2 Is Not Done Yet — Could This New Drug In Clinical Trials Be The Safest Option For Treating COVID-19?

Read the latest report on NanoViricides here.

SARS-CoV-2 is not done yet — Although it is not grabbing as many headlines, the number of deaths are still greater than even a pandemic influenza year at last count. The virus is still lurking, causing COVID and long COVID.  Former White House COVID czar Ashish Jha has said  “There is a temptation to say it's all over and we don't have to think about COVID anymore. The way I look at it is the virus can still surprise us.”

We have learnt just to live with it, thanks to the immunity from vaccines and from the viral infection itself. However, according to the World Health Organization (WHO), “Even in vaccinated individuals, uncertainties remain about the duration of protection,  the effectiveness of current vaccines and the efficacy of existing treatments for COVID-19  against emerging SARS-CoV-2 variants and subvariants.” Despite over 300 clinical trials, there are only three approved drugs that remain. Unfortunately, each of them has limitations. 

Current Approved Therapies Have Significant Limitations 

Remdesivir, from Gilead Sciences GILD has only received a conditional recommendation from the WHO for patients with severe COVID-19. Also, Remdesivir can only be administered as an infusion in a hospital, limiting the patient populations who can get access to the drug. 

Two other drugs, Molnupiravir by Merck & Co. MRK and Paxlovid by Pfizer PFE are both orally available. The WHO has issued a strong recommendation for Paxlovid, but only a conditional recommendation for Molnupivavir for patients with severe COVID-19 or non-severe COVID-19 at the highest risk of hospitalization.

However, the WHO notes limitations to both of these drugs in its guidelines, and it also doesn’t advise certain populations to take these treatments on account of drug-to-drug interactions or other side effects.

This indicates a need for a safer and more comprehensive treatment. A unique and novel drug that looks to fulfill this unmet medical need is NV-CoV-2, developed by NanoViricides, Inc. NNVC. 

NanoViricides recently announced it has begun clinical trials for NV-CoV-2, an innovative treatment for patients with COVID-19. NanoViricides is developing a novel nanomedicine platform of antiviral therapies, and its leading drug candidate is NV-CoV-2, which contains API NV-387. 

Dr. Anil Diwan, President and CEO of NanoViricides, described the drug as an exciting opportunity to fill an “as-yet-unmet medical need of a highly effective broad-spectrum, anti-coronavirus drug that can be used for all patient populations.”

The drug has already demonstrated a robust safety profile in pre-clinical animal safety and tolerability evaluations, as well as showing itself to be non-immunogenic and non-mutagenic in standard tests.

These data suggest a potentially exciting feature of NV-CoV-2 in its ability to treat all patient populations.

Now with the trial beginning, its primary outcomes include: “To evaluate the safety and tolerability with the initial administration of NV-CoV-2 in healthy human subjects,” and “To find the maximum tolerated dose for the support of phase-2 clinical trials.”

It employs NV-387, a first-in-class chemical nanomedicine with a novel mechanism of action called the “Re-Infection Blocker” designed to entirely eliminate the virus from the patient’s system.

The drug will be trialed on patients with mild to moderate COVID-19, in the Phase 1b part of the clinical trial, though the company believes this could also be efficacious for patients with severe coronavirus and even for hospitalized cases. Note that NV-CoV-2 has been shown to be significantly more effective than Remdesivir in lethal lung infection models of human coronavirus NL-63 in rodents.  Remdesivir is the only drug currently approved for hospitalized cases. 

There are multiple formulations of NV-CoV-2, including as an oral syrup and oral gummy, for outpatient use, which broadens the patient population that could take this treatment. An injectable formulation was also developed for hospitalized patients.

NanoViricides believes that the safety and efficacy of this drug could make it a popular choice, as some of the more popular alternative COVID-19 treatments available are either less safe or are contra-indicated for several classes of patients. 

According to NanoViricides, this opens up a huge market for its drug, NV-CoV-2. As a broad-spectrum anti-coronavirus drug with multiple formulations, it can be given to any patient group. Plus, its novel nanomedicine technology potentially makes it a highly effective treatment for COVID-19 as well as other coronaviruses. 

Learn more about how NanoViricides is tackling different viruses by visiting its website.

Featured photo by Karolina Grabowska on Pexels. 

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