NanoViricides Drug Can Fight Bird Flu Pandemic; H5N1 Virus Cannot Escape
NanoViricides (NYSE:NNVC) announced its readiness to combat bird flu with its broad-spectrum antiviral drug NV-387. The company claims the H5N1 virus cannot escape this drug despite its rapid mutation capability. NV-387 has demonstrated activity against various viruses, including Coronaviruses, Influenza, RSV, and Poxviruses.
Two major H5N1 genotypes are currently circulating: the highly pathogenic D1.1, which caused one death in the US and one critical illness in Canada, and the less pathogenic B3.13, found in dairy cows and workers. While human-to-human transmission hasn't been observed, scientists note that a single point mutation could change this scenario.
In animal studies, NV-387 has shown superior activity compared to existing treatments like Tamiflu, Rapivab, and Xofluza. The company is currently focused on advancing NV-387 into Phase II human clinical trials.
NanoViricides (NYSE:NNVC) ha annunciato la sua prontezza a combattere l'influenza aviaria con il suo farmaco antivirale ad ampio spettro NV-387. L'azienda afferma che il virus H5N1 non può sfuggire a questo farmaco nonostante la sua rapida capacità di mutazione. NV-387 ha mostrato attività contro vari virus, tra cui i Coronaviruses, l'Influenza, il RSV e i Poxvirus.
Attualmente circolano due principali genotipi H5N1: il D1.1, altamente patogeno, che ha causato una morte negli Stati Uniti e un caso critico in Canada, e il B3.13, meno patogeno, trovato in mucche da latte e lavoratori. Anche se la trasmissione da uomo a uomo non è stata osservata, gli scienziati notano che una singola mutazione potrebbe cambiare questo scenario.
Negli studi su animali, NV-387 ha mostrato un'attività superiore rispetto ai trattamenti esistenti come Tamiflu, Rapivab e Xofluza. L'azienda è attualmente concentrata sull'avanzamento di NV-387 nella fase II delle sperimentazioni cliniche umane.
NanoViricides (NYSE:NNVC) anunció su disposición para combatir la gripe aviar con su medicamento antiviral de amplio espectro NV-387. La compañía afirma que el virus H5N1 no puede evadir este fármaco a pesar de su rápida capacidad de mutación. NV-387 ha demostrado actividad contra varios virus, incluidos los Coronaviruses, la Influenza, el RSV y los Poxvirus.
Actualmente circulan dos genotipos principales de H5N1: el D1.1, altamente patógeno, que causó una muerte en EE. UU. y una enfermedad crítica en Canadá, y el B3.13, menos patógeno, encontrado en vacas lecheras y trabajadores. Si bien no se ha observado transmisión de humano a humano, los científicos señalan que una sola mutación puntual podría cambiar este escenario.
En estudios con animales, NV-387 ha mostrado una actividad superior en comparación con tratamientos existentes como Tamiflu, Rapivab y Xofluza. La compañía se está concentrando actualmente en avanzar NV-387 a la fase II de ensayos clínicos en humanos.
나노바이러사이드(NYSE:NNVC)는 광범위 항바이러스 약물 NV-387로 조류 독감을 퇴치할 준비가 되었음을 발표했습니다. 회사는 H5N1 바이러스가 빠른 변이 능력에도 불구하고 이 약을 피할 수 없다고 주장합니다. NV-387는 코로나바이러스, 독감, RSV 및 폭스바이러스 등 다양한 바이러스에 대해 활성을 보여주었습니다.
현재 두 가지 주요 H5N1 유전형이 순환하고 있습니다: 미국에서 한 명의 사망자와 캐나다에서 한 명의 중환자를 유발한 매우 병원성인 D1.1과, 유제품 소와 노동자에서 발견된 덜 병원성인 B3.13입니다. 인간 간의 전염은 관찰되지 않았지만, 과학자들은 단일 점 변이가 이 상황을 바꿀 수 있다고 언급합니다.
동물 연구에서 NV-387는 타미플루, 라피바브, 그리고 크로플루자와 같은 기존 치료제에 비해 우수한 활성을 보였습니다. 현재 회사는 NV-387을 2상 인간 임상 시험으로 진행하는 데 집중하고 있습니다.
NanoViricides (NYSE:NNVC) a annoncé sa préparation à lutter contre la grippe aviaire avec son médicament antiviral à large spectre NV-387. La société affirme que le virus H5N1 ne peut pas échapper à ce médicament malgré sa capacité de mutation rapide. NV-387 a montré une activité contre divers virus, y compris les Coronaviruses, la Grippe, le RSV et les Poxvirus.
Deux principaux génotypes H5N1 circulent actuellement : le D1.1, hautement pathogène, qui a causé un décès aux États-Unis et une maladie critique au Canada, et le B3.13, moins pathogène, trouvé chez les vaches laitières et les travailleurs. Bien que la transmission de l'homme à l'homme n'ait pas été observée, les scientifiques notent qu'une seule mutation ponctuelle pourrait changer ce scénario.
Dans les études animales, NV-387 a montré une activité supérieure par rapport aux traitements existants tels que Tamiflu, Rapivab et Xofluza. L'entreprise se concentre actuellement sur l'avancement de NV-387 dans la phase II des essais cliniques humains.
NanoViricides (NYSE:NNVC) hat seine Bereitschaft angekündigt, die Vogelgrippe mit seinem Breitband-Antivirenmittel NV-387 zu bekämpfen. Das Unternehmen behauptet, dass das H5N1-Virus diesem Medikament trotz seiner schnellen Mutationsfähigkeit nicht entkommen kann. NV-387 hat gegen verschiedene Viren, darunter Coronaviren, Influenza, RSV und Poxviren, Wirksamkeit gezeigt.
Derzeit zirkulieren zwei Hauptgenotypen von H5N1: der hochpathogene D1.1, der einen Todesfall in den USA und einen kritischen Fall in Kanada verursacht hat, und der weniger pathogene B3.13, der in Milchkühen und Arbeitern gefunden wurde. Während eine Übertragung von Mensch zu Mensch nicht beobachtet wurde, merken Wissenschaftler an, dass eine einzelne Punktmutation dieses Szenario ändern könnte.
In Tierversuchen hat NV-387 eine überlegene Aktivität im Vergleich zu bestehenden Behandlungen wie Tamiflu, Rapivab und Xofluza gezeigt. Das Unternehmen konzentriert sich derzeit darauf, NV-387 in die Phase II der klinischen Studien am Menschen zu bringen.
- NV-387 demonstrated superior efficacy compared to existing treatments in animal studies
- Drug shows broad-spectrum activity against multiple virus types (Coronaviruses, Influenza, RSV, Poxviruses)
- Design enables potential effectiveness against 90-95% of human pathogenic viruses
- Drug is still in early development stages, not yet approved for human use
- No human clinical trial data available yet
- Requires substantial capital and time for development and regulatory approval
Insights
The announcement of NV-387's potential against H5N1 and other viruses represents a significant development in pandemic preparedness. The drug's host-mimetic design addresses a critical weakness in current antiviral approaches - viral mutation and escape. While existing antivirals like Tamiflu require precise targeting of viral proteins that can mutate, NV-387's mechanism targets stable host-cell features that viruses consistently use for infection.
The preclinical data showing superior performance against H3N2 compared to approved antivirals is promising, but several critical factors need consideration:
- The drug is still pre-IND stage, meaning significant regulatory hurdles remain before human trials can begin
- While broad-spectrum activity is claimed against multiple virus families, detailed efficacy data for each pathogen will be required
- The company's small market cap of
$17M raises questions about funding for full clinical development
The timing is particularly relevant given growing concerns about H5N1's spread to mammals and its detection in U.S. dairy cows. A broad-spectrum antiviral could command significant government interest for strategic stockpiling, similar to how Tamiflu was stockpiled for pandemic preparedness. However, this remains highly speculative until clinical validation.
From an investment perspective, while the technology appears promising, the early stage and significant capital requirements for clinical development present substantial risks. The company's ability to advance NV-387 will likely depend on securing major partnerships or government funding.
SHELTON, CT / ACCESS Newswire / February 11, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") declared today that it is ready to fight the bird flu with its revolutionary broad-spectrum antiviral drug NV-387, a drug that the Bird Flu virus H5N1 likely cannot escape despite its ability to mutate rapidly with genomic changes.
An "opinion and analysis" article published in Scientific American on February 7th correctly recognizes that the H5N1 "virus is versatile…and mutating", although it rapidly devolves into unwarranted and unsubstantiated inflammatory and false assertions against the Trump administration (https://www.scientificamerican.com/article/the-us-is-not-ready-for-bird-flu-in-humans/).
This article's titular declaration that the "US is not ready for bird flu in humans" is myopic.
We beg to differ from this opinion, and hereby declare that our broad-spectrum antiviral drug NV-387 that H5N1 virus will not be able to escape even as it changes in the field, is ready to fight the battle and save lives, should a human H5N1 pandemic occur.
The said article is basically an opinion that is clearly limited to partial and biased analysis of current drugs and vaccine efforts for H5N1, and demonstrates total unawareness (or ignorance) of the failures (or very limited successes) of antiviral vaccine, antibody and small chemical drug approaches during the COVID pandemic. To wit, during COVID pandemic, vaccinated persons were still infected with the virus because the virus was ever-changing, and they became unwitting carriers of the virus. Thus, vaccination did not break the chain of virus transmission, and the R0 number continued to increase throughout the pandemic despite compulsory vaccinations. The immunity from vaccines was not long-lasting, and now immunity from natural COVID infection is thought to have been superior to that provided by the vaccines.
"Vaccines are not the right response for fast-moving viruses such as SARS-CoV-2 or H5N1, because vaccine deployment is at least 12 to 15 months behind the virus, when the virus has already moved on," commented Anil R. Diwan, PhD, adding "We must learn from past pandemics and past mistakes. We believe that the iconoclastic Trump 2.0 administration will heed these lessons."
NV-387 is ready to be a significant part of the pandemic preparedness and response arsenal, because it has already demonstrated activity against different and varied viruses including Coronaviruses (COVID), Influenza viruses, RSV, and even Poxviruses (MPox/Smallpox). Its design is thought to enable this drug NV-387 to be able to fight as many as 90
The bird-flu virus and its variants are highly unlikely to escape the broad spectrum, host-mimetic, antiviral drug NV-387, because all of these variants continue to land on the same host-side feature that NV-387 mimics. Further, in stringent lethal animal model studies to treat Influenza A H3N2 infection, NV387 has shown superior activity compared to osletamivir (Tamiflu®), peramivir (Rapivab®), and baloxavir (Xofluza®); all of these approved small chemical drugs are prone to escape by the virus with just single point mutations.
"We believe that the new administration will focus on rapid development and acquisition of broad-spectrum therapeutic drugs like NV-387 that the virus cannot escape, for the Nation's arsenal of antiviral weaponry, in order to prepare for not just a potential bird flu pandemic in humans but also potential spread of MPox outside of the African region, and potential Smallpox bioteerorism, all at the same time, with a single drug capable of fighting all of these fights, thus saving billions of dollars to the American taxpayer, instead of the failed strategy of chasing viruses by continuing to develop new multi-billion-dollar vaccines every few months that was adopted by the Biden administration in response to the COVID pandemic," Dr. Diwan stated.
Vaccines will now also face an increased barrier of being able to win over people to voluntarily take the vaccine shot that the people already know offers limited protection because so many people experienced a COVID infection multiple times even after getting vaccinated, due to variants.
"The Biden administration propagated only vaccines and antibodies development under the COVID response and later Project NextGen funding. This was in spite of the fact that antibodies, although rapidly given emergency use authorizations by the FDA, were losing efficacy every few months, as soon as a new variant of SARS-CoV-2 appeared. And yet the Biden administration continued to chase the changing virus with new vaccines and new antibodies, resulting in an extremely costly approach with little to show for it. Despite this, under the Biden administration, HHS has already sent
"I am certain the Trump 2.0 administration is in no mood to entertain such wasteful expenditures for H5N1 bird flu response," said Dr. Diwan, adding, "Everyone understands that a broad-spectrum drug that the virus cannot escape is an essential part of an excellent multi-pronged strategy for pandemic response."
"I implore the HHS Secretary nominee Robert F. Kennedy Jr. to take the lessons of COVID pandemic to heart, and produce a consummate response to Bird Flu. Just as the Trump 1.0 administration deployed Operation Warp-Speed to enable development of the first ever modern mRNA vaccine rapidly, a similar approach needs to be adopted to promote rapid development of new therapeutic drugs against bird flu that the virus would not escape, so that there is an arsenal of weapons against the virus to treat the infection and save lives, while there is still time," Diwan said.
Two different major genotypes of bird flu H5N1 are found to be circulating, both of which have caused infections in humans. A highly pathogenic genotype D1.1 from birds has led to one critical month-long illness in Canada and one death in the US signifying the potential for high morbidity and mortality from this genotype if it spreads in humans. A somewhat less pathogenic genotype B3.13 from dairy cows in several states including California has infected dairy workers that have recovered. In addition, D1.1 was recently found in milk from dairy cows in Nevada. Both genotypes are also found to be infecting many other mammals including cats, dogs and pigs. Dairy workers, persons exposed to wild birds or free-range flocks, and even veterinarians have been infected with bird flu.
Fortunately, there is no strong evidence of human to human transmission yet. Therefore, the threat of potential pandemic is still considered to be low. However, scientists have already found that a single point mutation in this virus can change that scenario quickly. Thus, the urgency of developing a viable broad-spectrum antiviral drug response is now immediate.
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.
The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields 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.
Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we are developing as a treatment of RSV, COVID, Long COVID, Influenza, H5N1 Bird Flu, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. 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 currently focused on advancing NV-387 into Phase II human clinical trials.
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 RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. 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". WHO is the World Health Organization. R&D refers to Research and Development.
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
ir@nanoviricides.com
SOURCE: NanoViricides, Inc.
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FAQ
What is NanoViricides' NV-387 drug's effectiveness against H5N1 bird flu?
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How does NV-387 differ from traditional antiviral treatments for H5N1?
