Orally Administered NV-387 Results in Ideal Flat Blood Concentration Profile for Sustained Antiviral Effect
NanoViricides announced positive preclinical results for its lead nanomedicine drug candidate, NV-387, which demonstrates an ideal flat blood concentration profile upon oral administration in animal models. This profile allows sustained antiviral effects, requiring less frequent dosing. In both rat and dog models, blood concentrations of NV-387 peaked in one hour and remained stable for eight hours, declining to baseline after twelve hours. After repeated doses, the drug's concentration plateaued for 24 hours, extending to 36 hours before returning to baseline. NV-387 showed efficacy in treating various viral infections, including RSV, COVID-19, and Influenza, and outperformed existing therapeutics. Clinical safety studies of NV-387 in Phase I human trials revealed no adverse events. The company aims to advance NV-387 into Phase II trials for RSV treatment.
- NV-387 showcases a favorable flat blood concentration profile, allowing sustained antiviral effects with less frequent dosing.
- Preclinical animal studies indicate NV-387's efficacy against multiple viruses, including RSV, COVID-19, and Influenza.
- Phase I human clinical trials reported no adverse events, indicating good safety and tolerability.
- The drug's unique profile minimizes the risk of unwanted side effects, even at high dosages.
- NV-387 is effective upon oral administration, unlike many nanomedicines requiring injection or topical application.
- The company has not yet completed Phase II clinical trials, so further efficacy and safety data are needed.
- There is no assurance that NV-387's preclinical success will translate to successful clinical trial outcomes.
- The path to drug development is lengthy and capital-intensive, posing financial risks.
- Dependence on external collaborators and consultants may delay progress.
Insights
The recent findings on NV-387 demonstrate a promising pharmacokinetic profile, sustaining blood concentration levels over extended periods in animal models. Such consistency hints at the potential for infrequent dosing, which can improve patient compliance and potentially enhance the therapeutic experience. The flat blood concentration profile, which minimizes peaks that can cause side effects, presents a considerable advantage over conventional antiviral medications that typically show rapid spikes and declines. Additionally, the absence of adverse events in Phase I human trials is noteworthy. This new data could support faster progression into Phase II trials, particularly given the compelling preclinical efficacy results against multiple respiratory viruses.
The implications of NV-387’s pharmacokinetic properties are significant in a clinical context. A flat blood concentration profile can result in a more stable therapeutic window, reducing the risk of toxic side effects while maintaining efficacy. This profile is particularly valuable for treating viruses like RSV and COVID-19, where keeping a consistent antiviral presence in the bloodstream can be important for combatting the infection effectively. Moreover, the ability of NV-387 to potentially treat a range of viruses with a single medication highlights its broad-spectrum antiviral capability, which is rare in the field of antiviral treatments. This characteristic makes it a versatile tool in the fight against viral pandemics and endemic infections.
The development of NV-387 could be a game-changer in the antiviral drug market. Its unique pharmacokinetic profile allows for extended efficacy with less frequent dosing, which can substantially improve patient adherence and reduce healthcare costs. The broad-spectrum activity reported in animal models suggests a potential market advantage, positioning NV-387 as a single solution for multiple viral infections, including RSV, COVID-19 and influenza. This could lead to significant market penetration if clinical trials continue to show positive results. Furthermore, the successful absence of adverse effects in initial human trials suggests a potentially favorable safety profile, making it more attractive to both prescribers and patients.
A First-In-Class, Broad-Spectrum Antiviral Agent Intending To Revolutionize Treatment of Viral Infections Including RSV, COVID, Influenzas and More
SHELTON, CT / ACCESSWIRE / June 11, 2024 / NanoViricides, Inc. (NYSE Amer.:NNVC) (the "Company"), a clinical-stage global leader in broad-spectrum antiviral nanomedicines, reports that its clinical stage lead nanoviricide broad-spectrum antiviral drug candidate, NV-387, results in an ideal flat blood concentration profile for an extended time period upon oral administration in two different animal models.
This unusual but highly desirable, extended flat time profile of blood concentration of orally given NV-387 enables sustained antiviral effect over a long period of time, allowing infrequent dosing regimens.
The blood concentration of NV-387 increased to a peak in approximately the first hour, and then remained almost constant for eight hours or longer, thereafter, the concentration declined to reach baseline at about twelve hours; upon oral administration of a first dose of NV-387. This was found to be the case in studies involving two different animal models, namely, rats and dogs.
After repeated dosings, the plateau of the sixth dose lasted for at least 24 hours, thereafter declining to baseline at about 36 hours, in both the rat and dog animal models.
The same plateau profile phenomenon was observed in both male and female animals, as well as in both species of animals, namely, rat and dog.
The blood concentration profile of NV-387 is indicative of the formation of a buffering reservoir of the drug in the host that releases the drug at a regular rate into the bloodstream.
The Company has recently reported that NV-387, when given as a slow bolus intravenous infusion, was found to result in a relatively flat plateau of blood concentration of the drug with very slow decline over a 24 hour period in a cynomolgus monkey model.
The flat time profile of NV-387 indicates that even at very high dosings, its blood concentration is unlikely to result in unwanted side effects. Typical drugs result in a rapid rise in blood concentration of the drug in generally the first hour to a peak, thereafter rapidly exponentially decreasing to baseline in 3-6 hours. In order to ensure that the concentration of the drug is sufficiently high to provide antiviral effect at say 2-4 hours from dosing, the drug dose chosen would be relatively high, and can therefore result in a substantially greater drug concentration in the beginning, which can result in unwanted side effects. Therefore, a sustained, nearly flat drug concentration profile is highly sought-after.
In the repeat-dose oral NV-387 administration studies in both rat and dog models cited above, two doses were given on the first day (at 0h and 12h), followed by third dose at 24 h, and then daily doses at 24 hour intervals, for a total of six doses in five days.
The Company has previously reported that NV-387 when administered orally resulted in strong antiviral effects in several respiratory viruses. In lethal infections with hCoV- NL63 (a model for SARS-CoV-2, cause of COVID), RSV, as well as Influenza A/H3N2, orally administered NV-387 was found to be superior to approved therapeutics where available.
In fact, the Company has found that NV-387 enabled complete cure of RSV infection in the mouse model of lethal lung infection with RSV A2.
The Company therefore believes that NV-387 is a first-in-class, broad-spectrum antiviral agent that could be a revolutionary single drug for the treatment of a multitude of respiratory viral infections including RSV, COVID, Influenzas and potentially other viruses.
The presented non-clinical studies of pharmacokinetics of orally administered NV-387 provide support that the strong antiviral effect seen in these antiviral animal model efficacy studies is the result of NV-387 circulating in the body and exerting its direct antiviral effects.
"NV-387 is a unique host-mimetic, direct acting antiviral drug that the virus is highly unlikely to escape," said Anil R. Diwan, Ph.D, President, "We were pleasantly surprised that NV-387 is highly active upon oral administration, and now we have found that this is because it indeed crosses into the bloodstream upon oral administration, enabling systemic antiviral effects." He further explained that, "NV-387 may be the very first or one of very few nanomedicines that are effective upon oral administration. Nanomedicines in general are restricted to injectable or topical delivery. NV-387 is thus unique in this respect."
NV-387 has recently completed Phase I human clinical safety tolerability studies with no reported adverse events in India, as the Company has reported previously.
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. This trial was conducted by the drug sponsor, Karveer Meditech Pvt. Ltd., our licensee and collaborator in India.
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.
"NOAEL" means "No-Observed-Adevrese-Event-Level", which is the maximum dosage employed at which there were no adverse events found in animal studies.
"MTD" means "Maximum Tolerated Dose", which is the maximum dosage employed that does not compromise survival of the animals.
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.
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