Can Nanotechnology offer Better Solutions for COVID, RSV and other Viruses?

Rhea-AI Summary

NanoViricides, Inc. (NYSE American: NNVC) is developing NV-387, a broad-spectrum antiviral drug candidate showing promise against multiple viruses, including COVID-19, RSV, and influenza. The company recently completed a Phase 1 safety study for NV-387, with results expected in the second half of 2024. A Phase 2 clinical trial for RSV is being planned.

Key highlights:

• NV-387 demonstrated 180% improvement in survival compared to Remdesivir's 50% in animal studies
• Oral and injectable formulations developed
• Showed excellent safety and tolerability in Phase 1 human trials
• Potential to address limitations of current COVID-19 treatments
• Broad spectrum activity could represent a new paradigm in viral therapy

Positive

• Completion of Phase 1 safety study for NV-387, with results expected in H2 2024
• Planning of Phase 2 clinical trial for RSV treatment
• NV-387 showed 180% improvement in survival compared to Remdesivir's 50% in animal studies
• Excellent safety and tolerability demonstrated in Phase 1 human trials
• Broad spectrum activity against multiple viruses, including COVID-19, RSV, Influenza, and Poxviruses

Negative

• No FDA approval for NV-387 yet, still in clinical trial stages
• Potential competition from established antiviral drugs and vaccines in the market
• Uncertain timeline for regulatory approvals and market launch

Insights

Biotech Industry Analyst

The article discusses the potential of nanotechnology in developing antiviral solutions, particularly focusing on NanoViricides, Inc. (NYSE American: NNVC) and its lead candidate NV-387. While the news is intriguing, it's important to approach it with caution.

NV-387's broad-spectrum antiviral potential is noteworthy, especially its reported effectiveness against coronaviruses, RSV, influenza and poxviruses. The 180% improvement in survival rates compared to Remdesivir in animal studies is impressive. However, it's important to remember that animal study results don't always translate to human efficacy.

The completion of a Phase 1 safety study is a positive step, but without published results, it's premature to draw conclusions. The planned Phase 2 trial for RSV will be a critical milestone to watch.

The global antiviral drugs market's projected growth to $74.75 billion by 2028 presents a significant opportunity. However, NanoViricides faces stiff competition from established players like Pfizer and Gilead, as well as other emerging biotech companies.

Investors should consider the following:

• The company's financial position and burn rate
• The timeline for potential commercialization
• The regulatory pathway and potential hurdles
• The company's ability to secure partnerships or funding for late-stage trials

While the technology shows promise, it's still in early stages. Investors should weigh the potential upside against the inherent risks of biotech investments, especially in early-stage companies.

Medical Research Analyst

NanoViricides' approach to antiviral therapy is innovative, but it's essential to scrutinize the data critically. The company's nanoviricide technology, which aims to mimic the host cell receptors that viruses bind to, is an intriguing concept. However, several points warrant attention:

1. Broad-spectrum activity: While appealing, it's unusual for a single compound to be highly effective against such a diverse range of viruses. This claim requires robust clinical evidence.

2. Safety profile: The reported absence of adverse events in the Phase 1 trial is promising, but more extensive safety data will be needed, especially given the novel nature of the technology.

3. Comparative efficacy: The 180% improvement over Remdesivir in animal studies is striking. However, we need to see how this translates to human trials, particularly in comparison to current standard-of-care treatments.

4. Oral formulation: The development of an oral formulation could be a significant advantage if efficacy is maintained.

5. Resistance potential: The claim that antiviral resistance against NV-387 would be "highly unlikely" is bold and requires long-term data to substantiate.

While the preliminary data is encouraging, it's important to await peer-reviewed publications and results from larger, well-designed clinical trials before drawing definitive conclusions about NV-387's potential impact on antiviral therapy.

Vancouver, Kelowna, and Delta, British Columbia--(Newsfile Corp. - August 2, 2024) - Investorideas.com, a go-to investing platform covering biotech and nanotechnology issues a snapshot looking at news and developments in the antiviral market, featuring NanoViricides, Inc. (NYSE American: NNVC), a development stage company that is creating special purpose nanomaterials for antiviral therapy.

Read the full article on Investorideas.com

https://www.investorideas.com/News/2024/nanotech/08020Better-Solutions-for-Viruses.asp

From COVID to RSV and now Bird Flu, the global threat of viruses is only a headline away and there is a lot of profit for companies offering solutions.

The Global Antiviral Drugs Market is estimated to reach USD 74.75 Bn by 2028, says Research and Markets and nanotech companies are aiming for a big piece of that pie.

Talking about nanotech's future role in the antiviral market, a recent article in Nature says, "Nanotechnology with precise control over the properties and structures of nanomaterials holds tremendous potential in the field of antiviral applications. The application of nanotechnology in the antiviral field, including the efficient delivery of antiviral drugs, the blocking of viral infections, and the activation of immune responses, offers new strategies and approaches, bringing renewed hope for infectious disease treatment and prevention."

According to a recently released report from Zacks Small Cap Research, "NanoViricides (NYSE American: NNVC) Broad Spectrum Technology Represents Potential Paradigm Shift in Viral Therapy."

Continued: "NanoViricides is a biopharmaceutical company developing anti-viral therapeutics based on its proprietary nanoviricide technology. A Phase 1 safety study of the company's lead asset, NV-387, was recently completed and we anticipate results from the study being available in the second half of 2024. A Phase 2 clinical trial in Respiratory Syncytial Virus (RSV) is currently being planned. As opposed to currently available antiviral therapies in which each compound is only active against a unique type of virus, NanoViricides has disclosed preclinical results for NV-387 in multiple viral models that demonstrates the broad-spectrum action of the compound. These results could represent a new paradigm in viral therapy."

On July 24^th NanoViricides issued a reminder on the strong safety and effectiveness against coronaviruses demonstrated by its lead clinical drug candidate NV-387.

"President Joe Biden has thankfully recovered from the bout of COVID caused by a new variant," said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, "This again brings into limelight the lack of strong drugs against COVID; a gap that NV-387 is expected to fulfill."

From the news: There is clearly a need for a highly effective and preferably oral drug against COVID. COVID in the USA has become a biannual affair, with ever new, different variants leading each new wave. COVID continues to claim annually greater numbers of lives and hospitalizations than Influenza.

We believe it is important to bring to the attention of everyone how strong the activity of NV-387 in animal studies against coronaviruses has been, even compared with the most effective anti-coronavirus drug, namely, remdesivir (Veklury® Gilead).

We have studied a lethal lung infection in rats with a coronavirus that results in the same pathology but only milder than the delta variant, in humans as compared to COVID.

In one study, NV-387 intravenous injection (I.V.) treatment led to a substantial improvement in survival, of 180%, as compared to Remdesivir (Pfizer Inc.), of only 50%.

Continued: We thereafter developed an oral formulation of NV-387 and studied its effect in comparison to the NV-387 I.V. treatment.

The results indicate that NV-387 oral drug is expected to be highly effective in treatment of COVID infections. The results also suggest that for hospitalized patients, NV-387 injectable form would be preferable over the oral form.

The focus throughout the pandemic has been primarily on antibodies and vaccines. Antibodies as drugs are now clearly evidenced to be not useful for a long enough period to provide major public health benefits. The limits of vaccines and vaccination campaigns both have also become clearly evident. In this scenario, Paxlovid™ (Pfizer Inc.), remains the only oral drug available, in spite of its known weak clinical effectiveness, which is evidenced in clinical trials that showed that in otherwise healthy adults it was not shown to be better than placebo.

Additional drug development for COVID treatment is clearly a public health necessity. NV-387 is possibly the most advanced drug candidate that has demonstrated both strong activity and safety in a number of studies towards regulatory approvals.

NV-387 has undergone Phase I human clinical trial to evaluate the safety and tolerability in the form of two different oral formulations, namely, NV-CoV-2 Oral Syrup, and NV-CoV-2 Oral Gummies in India. There were no dropouts and there were no reported adverse events, indicating excellent safety and tolerability of NV-387 even at high dosage levels.

We have also found that NV-387 has a very wide antiviral spectrum, covering at least the following: Coronaviruses, RSV, Influenza, and Poxviruses (Smallpox/Mpox). This indicates that antiviral drug resistance against NV-387 would be highly unlikely.

Reporting on Pfizer's Paxlovid™, Reuters recently noted, "A 15-day course of Pfizer's (PFE.N), opens new tab COVID-19 antiviral treatment Paxlovid did not relieve symptoms of long COVID, according a study by Stanford University researchers."

Continued: Currently, there are no proven treatments specifically for long COVID in which a host of symptoms can last for many months after initial coronavirus infection.

Scientists and patients had hoped that Pfizer's two-drug oral treatment would ease symptoms of long COVID after anecdotal reports of patients who said Paxlovid helped them.

Continued: But the15-week, 155-participant study failed to show that a 15-day course helped more than a placebo in reducing fatigue, brain fog, shortness of breath, body aches, or gastrointestinal or cardiovascular symptoms. Trial participants, on average, had been sick more than 16 months before enrolling in the trial.

"We did not see a measurable difference based on patient reported outcomes in the six composite symptoms together," Stanford Medicine Professor, Dr. Upinder Singh said in an interview. "We didn't see a benefit in individual symptoms either."

The vaccine market is shifting after companies were making record profits during COVID, but there is still big money at play and new viruses to address.

FiercePharma reported, "GSK reported sales of 1.24 billion euros ($1.53 billion) in the third and fourth quarter for its RSV shot Arexvy, which is for people ages 60 and older. Meanwhile, Sanofi and AZ-partnered pediatric shot Beyfortus generated 547 million euros ($592 million) in sales, a figure expected to double in 2024."

Continued: "Industry experts who we've spoken to believe the global market opportunity for RSV vaccines is substantial, possibly reaching ($9 billion to $10 billion) and supporting attractive growth for leading companies," Third Bridge's Brown noted.

Zacks Equity Research looking at the biotech sector earlier this week, commented on Moderna, Inc., once the darling of the COVID era, noting it is diversifying its pipeline. "Moderna recently obtained a significant boost with the FDA approval of RSV vaccine mResvia to prevent RSV-associated lower respiratory tract disease (RSV-LRTD) in older adults aged 60 years and above. The vaccine is scheduled for commercial launch during the 2024 fall season.

The company plans to launch several new marketed products over the next five years. With these potential launches, management aims to not only boost its revenues but also reduce dependence on Spikevax. As one of the first-ever COVID-19 vaccine makers, Moderna's robust product sales boosted cash resources and enabled it to accelerate its pipeline development. The company is developing cytomegalovirus, cancer and influenza vaccines in late-stage studies."

Vaccines are not the only answer to virus treatment, so big pharma will be looking to innovate to capture market share and new opportunities.

NanoViricides, Inc. (NYSE American: NNVC) said in its most recent news, "We are now seeking collaborations with Pharma companies to bring this remarkable drug, NV-387, towards regulatory approvals for multiple antiviral indications."

NanoViricides stated earlier in July, "We are living in a world with many viruses that threaten our health. The current model of developing a drug against each virus separately is expensive and untenable with the myriad of viruses affecting humans that are gaining major foothold."

"NV-387 turns this drug development model on its head, with a single drug that would be effective against many of these viruses. It simplifies preparedness for pandemics. It reduces cost of development to a single drug instance."

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FAQ

What is NanoViricides' lead drug candidate for antiviral therapy?

NanoViricides' lead drug candidate is NV-387, a broad-spectrum antiviral therapeutic showing promise against multiple viruses, including COVID-19, RSV, and influenza.

What were the results of NV-387's animal studies compared to Remdesivir?

In animal studies, NV-387 demonstrated a 180% improvement in survival compared to Remdesivir's 50% in a lethal lung infection model with a coronavirus.

Has NanoViricides (NNVC) completed any clinical trials for NV-387?

Yes, NanoViricides has completed a Phase 1 safety study for NV-387, with results expected in the second half of 2024. They are also planning a Phase 2 clinical trial for RSV treatment.

What formulations of NV-387 has NanoViricides (NNVC) developed?

NanoViricides has developed both oral and injectable formulations of NV-387. The oral formulations include NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies.

What is the potential market size for antiviral drugs according to the press release?

According to Research and Markets, the Global Antiviral Drugs Market is estimated to reach USD 74.75 Billion by 2028.