A Novel Broad-Spectrum Antiviral with Activity Against RSV
NanoViricides announced that its antiviral drug candidate, NV-387, showed complete survival in mice lethally infected with RSV (Respiratory Syncytial Virus) in a recent study.
The study compared NV-387 with the currently approved RSV treatment, ribavirin. While NV-387 led to the complete survival of animals over a 21-day period, ribavirin resulted in the death of all subjects by day 14.
RSV is a major cause of hospitalizations and deaths among children under 5 and adults over 65. The company's NV-387 is aimed to provide a safer and more effective treatment option for these vulnerable groups.
The company has completed Phase 1a/1b human clinical trials for NV-387 with no reported adverse events and plans to advance to Phase II trials for RSV treatment.
- NV-387 demonstrated complete survival in mice lethally infected with RSV.
- The study showed NV-387 was significantly more effective than ribavirin, the only approved RSV treatment.
- NanoViricides completed Phase 1a/1b human clinical trials for NV-387 with no adverse events.
- Plans to advance NV-387 into Phase II human clinical trials for RSV treatment.
- NV-387 showed activity against multiple viruses including COVID-19 and Influenza.
- Ribavirin, the current RSV treatment, led to the death of all subjects by day 14.
- The company's development path is lengthy and requires substantial capital.
- There is no assurance that NV-387 will show sufficient effectiveness and safety in human clinical development.
- No specific timeline for filing an IND for other drug candidates due to dependency on external collaborators.
Insights
The recent study results on NV-387 demonstrate a significant advancement in the treatment of RSV. The complete survival of lethally infected animals suggests the drug's robust efficacy. Ribavirin, the current standard, has extensive toxicity, making NV-387 a potentially safer alternative. The extended dosing regimen leading to complete survival is noteworthy and surpasses previous results where NV-387 matched ribavirin. This indicates that prolonged administration significantly boosts its effectiveness.
From a research standpoint, these findings suggest NV-387 could fill a critical gap in RSV treatment, particularly for vulnerable groups like infants and elderly. However, it's essential to remember that these are preclinical results. While promising, translating animal model success to humans involves additional complexities. The progression to Phase II clinical trials will be important in confirming these results in humans. Investors should monitor these trials closely as they will determine the drug's future market potential.
The announcement of NV-387's efficacy in animal models is a positive signal for NanoViricides, potentially positioning the company as a key player in the antiviral market. The current lack of effective and safe treatments for RSV offers a substantial market opportunity. With RSV-related hospitalizations and mortality rates significantly high, a successful treatment could capture a large market share. Moreover, NV-387's promising results could accelerate investor interest, potentially boosting the company's stock value.
However, the path to commercialization is still fraught with uncertainties. Drug development is a capital-intensive and lengthy process and while the results are promising, they are still at the preclinical stage. The company will need substantial funding to advance through clinical trials. It's also worth noting that similar companies have encountered setbacks in transitioning from animal models to human trials. Investors should weigh these risks and consider the company’s financial health and funding sources.
The positive outcomes of NV-387 in a lethally infected animal model could significantly impact the RSV treatment market, especially if the drug progresses successfully through human trials. The unmet need in treating RSV, combined with the high incidence rates among young children and elderly populations, presents a lucrative market opportunity. If NV-387 proves effective in humans, it could disrupt the market currently dominated by ribavirin and other therapeutic agents.
Furthermore, the approval of vaccines for RSV prevention indicates a growing focus on combating this virus. NV-387 could complement these vaccines, providing both preventative and curative solutions. The company's strategy to target multiple respiratory viruses with NV-387 could also enhance its market position, offering a broad-spectrum antiviral solution. Investors should watch for updates on clinical trials and potential partnerships or funding rounds that could support the drug's development and market entry.
Complete Survival of Animals Lethally Infected into Lungs with RSV Achieved Upon NV-387 Oral Treatment
SHELTON, CT / ACCESSWIRE / May 14, 2024 / NanoViricides, Inc. (NYSE Amer.:NNVC) (the "Company"), a global leader in broad-spectrum antiviral nanomedicines, says that antiviral activity of NV-387 against RSV/A2 is strong enough to have resulted in full survival of lethally infected animals was achieved.
In this study, extended dosing of NV-387 given orally was compared with a high dose of ribavirin given orally for the same duration. Two doses were given on first day of dosing followed by one daily dose for next 9 days (for a total of 11 doses). NV-387 given by this dosing regimen led to complete survival of the mice beyond the 21 days study period, with no signs of pathology (disease) apparent on the last day of observation. In contrast, ribavirin led to death of all animals by 14 days.
Survival Lifespan of Lethally Infected Mice - Lung Infection with RSV A2 | |||||
|---|---|---|---|---|---|
Treatment | Survival, Days | Increase in Survival, Days | Increase in Survival, % | ||
NV-387, Oral | 22+ (Complete) | > | 14 | > | |
Ribavirin, Oral | 14 | 6 | |||
Vehicle | 8 | 0 | |||
Thus we believe NV-387 oral treatment is capable of curing RSV infection. There is currently no approved treatment for RSV other than ribavirin. A safe and effective treatment remains an unmet medical need.
"This is an extremely significant result. To date, in our lethal infection animal models, we have not observed uniform survival with any of the treatments, including approved drugs, against viruses that include Influenza A, Smallpox/Mpox, and Coronaviruses," said Anil R. Diwan, PhD, President and Chairman of the Company, adding, "Our studies are designed to be so lethal that the survival lifetime itself can be used as the ranking parameter to evaluate the effectiveness of a treatment. Complete survival is not expected in such studies, unless the drug is extremely effective."
Previously, in July 2023, we reported that NV-387 treatment led to survival in lethally RSV infected animals equal to that observed with ribavirin treatment. In this study, we extended the dosing regimens of both ribavirin and NV-387, to determine if that improves survival.
Ribavirin is the only currently approved drug for RSV infection, that can be used only as a last resort because of its extensive toxicity that limits its effectiveness.
RSV is an important disease in infants and children less than 5 years old, as well as in older persons over 65 years old. According to the CDC, each year in the United States, RSV leads to approximately:
- 58,000-80,000 hospitalizations among children younger than 5 years old;
- 60,000-160,000 hospitalizations among adults 65 years and older;
- 6,000-10,000 deaths among adults 65 years and older; and
- 100-300 deaths in children younger than 5 years old.
Two vaccines have recently been approved for protection of persons 60+ years old from RSV infection (Arexvy®, GSK, and Abrysvo®, Pfizer). Abrysvo was recently approved for use in pregnant women for protection of infants. Synagis (palivizumab), an antibody, as well as a new antibody, nirsevimab (Beyfortus®) have been approved by the US FDA for protection of newborn children at risk of RSV disease, but not for treatment of RSV infection and disease.
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. Additionally, nanoviricides mimick the host-side features that the viruses continue to require in spite of mutations, and therefore the viruses would be highly unlikely to escape the nanvoricide drugs.
Our lead drug candidate is NV-387 (drug product NV-CoV-2) for the treatment of RSV, COVID-19, Long COVID, Influenza, Bird Flu H5N1, and other respiratory viral infections. NV-387 has successfully completed a Phase 1a/1b human clinical trial in healthy subjects with no reported adverse events even at the highest and repeated dosages. The Company is currently focused on advancing NV-387 into Phase II human clinical trials for treatment of RSV infection.
Our other advanced candidate is NV-HHV-1 for the treatment of Shingles rash, HSV-1 "cold sores" and HSV-2 "genital ulcers". The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants.
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 and/or enteroviruses 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.
As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.
FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". API means active pharmaceutical ingredient.
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn, TraDigital IR
clyburn@tradigitalir.com
SOURCE: NanoViricides, Inc.
View the original press release on accesswire.com
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