NanoViricides is in a Great Position to Fight Potential Bird Flu Pandemic with a Drug that the Mercurial H5N1 Influenza A Virus is Unlikely to Escape
NanoViricides (NYSE:NNVC) announces its broad-spectrum antiviral drug candidate NV-387 as a potential solution against H5N1 bird flu pandemic. The company claims the virus is unlikely to develop resistance to NV-387 as it mimics essential host-side features that H5N1 continues to use despite mutations.
In animal studies, NV-387 demonstrated 88% increased survival compared to existing treatments like oseltamivir (25%), peramivir (38%), and baloxivir (38%). The drug has completed Phase I clinical trials with no adverse events and is preparing for Phase II trials for MPox treatment and respiratory virus infections.
The WHO has noted that current H5N1 strains show reduced susceptibility to existing treatments (NAIs and PBIs), highlighting the need for more effective solutions. While the US has stockpiled H5N1 vaccines, their effectiveness against potential pandemic strains remains uncertain.
NanoViricides (NYSE:NNVC) annuncia il suo candidato farmaco antivirale a largo spettro NV-387 come potenziale soluzione contro la pandemia di influenza aviaria H5N1. L'azienda afferma che il virus è improbabile che sviluppi resistenza a NV-387 poiché questo farmaco imita caratteristiche essenziali del lato dell'ospite che H5N1 continua ad utilizzare nonostante le mutazioni.
Negli studi sugli animali, NV-387 ha dimostrato un 88% di aumento della sopravvivenza rispetto ai trattamenti esistenti come oseltamivir (25%), peramivir (38%) e baloxivir (38%). Il farmaco ha completato la fase I degli studi clinici senza eventi avversi ed è in preparazione per gli studi di fase II per il trattamento di MPox e delle infezioni virali respiratorie.
L'OMS ha osservato che i ceppi attuali di H5N1 mostrano una ridotta suscettibilità ai trattamenti esistenti (NAIs e PBIs), evidenziando la necessità di soluzioni più efficaci. Sebbene gli Stati Uniti abbiano accumulato vaccini H5N1, la loro efficacia contro potenziali ceppi pandemici rimane incerta.
NanoViricides (NYSE:NNVC) anuncia su candidato a fármaco antiviral de amplio espectro NV-387 como una posible solución contra la pandemia de gripe aviar H5N1. La empresa afirma que es poco probable que el virus desarrolle resistencia a NV-387, ya que este fármaco imita características esenciales del lado del huésped que H5N1 continúa utilizando a pesar de las mutaciones.
En estudios con animales, NV-387 demostró un 88% de aumento en la supervivencia en comparación con tratamientos existentes como oseltamivir (25%), peramivir (38%) y baloxivir (38%). El fármaco ha completado ensayos clínicos de Fase I sin eventos adversos y se está preparando para ensayos de Fase II para el tratamiento de MPox y de infecciones virales respiratorias.
La OMS ha señalado que las cepas actuales de H5N1 muestran una menor susceptibilidad a los tratamientos existentes (NAIs y PBIs), destacando la necesidad de soluciones más efectivas. Aunque EE.UU. ha acumulado vacunas H5N1, su efectividad contra posibles cepas pandémicas sigue siendo incierta.
나노바이러스(NYSE:NNVC)는 H5N1 조류 독감 팬데믹에 대한 잠재적인 솔루션으로 광범위 항바이러스 약물 후보 NV-387를 발표했습니다. 회사는 이 바이러스가 변이에도 불구하고 H5N1이 계속 사용하는 필수 숙주 측면 특징을 모방하기 때문에 NV-387에 대한 저항성을 개발할 가능성이 낮다고 주장합니다.
동물 연구에서 NV-387은 기존 치료제인 오셀타미비르(25%), 페라미비르(38%) 및 발록시비르(38%)와 비교하여 88%의 생존율 증가를 입증했습니다. 이 약물은 부작용 없이 1상 임상 시험을 완료했으며 MPox 치료 및 호흡기 바이러스 감염을 위한 2상 시험 준비 중입니다.
WHO는 현재 H5N1 균주가 기존 치료제(NAI 및 PBI)에 대한 민감도가 감소하고 있다고 보고하여 더 효과적인 솔루션의 필요성을 강조했습니다. 미국은 H5N1 백신을 비축하고 있지만, 잠재적 팬데믹 균주에 대한 효과는 여전히 불확실합니다.
NanoViricides (NYSE:NNVC) annonce son candidat aux médicaments antiviraux à large spectre NV-387 comme une solution potentielle contre la pandémie de grippe aviaire H5N1. L'entreprise affirme que le virus est peu susceptible de développer une résistance à NV-387, car celui-ci imite des caractéristiques essentielles du côté hôte que H5N1 continue de utiliser malgré les mutations.
Dans les études animales, NV-387 a montré une augmentation de la survie de 88% par rapport aux traitements existants tels qu'oseltamivir (25 %), peramivir (38 %) et baloxivir (38 %). Le médicament a terminé les essais cliniques de phase I sans événements indésirables et se prépare pour des essais de phase II pour le traitement de MPox et des infections virales respiratoires.
L'OMS a noté que les souches actuelles de H5N1 montrent une sensibilité réduite aux traitements existants (NAIs et PBIs), soulignant la nécessité de solutions plus efficaces. Bien que les États-Unis aient stocké des vaccins H5N1, leur efficacité contre les souches pandémiques potentielles demeure incertaine.
NanoViricides (NYSE:NNVC) kündigt seinen Breitband-Antivirenmittel-Kandidaten NV-387 als potenzielle Lösung gegen die H5N1-Vogelgrippe-Pandemie an. Das Unternehmen behauptet, das Virus werde voraussichtlich keine Resistenz gegen NV-387 entwickeln, da es wesentliche Merkmale der Wirtsseite imitiert, die H5N1 trotz Mutationen weiterhin nutzt.
In Tierversuchen zeigte NV-387 eine 88%ige Steigerung der Überlebensrate im Vergleich zu bestehenden Behandlungen wie Oseltamivir (25%), Peramivir (38%) und Baloxavir (38%). Das Medikament hat die Phase-I-Klinikstudien ohne unerwünschte Ereignisse abgeschlossen und bereitet sich auf Phase-II-Studien für die Behandlung von MPox und Atemwegsvirusinfektionen vor.
Die WHO hat festgestellt, dass die aktuellen H5N1-Stämme eine reduzierte Empfindlichkeit gegenüber bestehenden Behandlungen (NAIs und PBIs) aufweisen, was die Notwendigkeit effektiverer Lösungen hervorhebt. Während die USA H5N1-Impfstoffe gelagert haben, bleibt deren Wirksamkeit gegen potenzielle Pandemie-Stämme ungewiss.
- NV-387 showed 88% increased survival rate in animal studies, significantly outperforming existing treatments
- Successfully completed Phase I trials with no adverse events
- Advancing to Phase II clinical trials for multiple applications
- Drug demonstrates broad-spectrum effectiveness against multiple viruses including COVID, RSV, Influenza, and Orthopoxviruses
- Phase II trials haven't started yet, indicating lengthy development timeline ahead
- Substantial capital still required for drug development
- No guarantee of successful human clinical development or final pharmaceutical product
Insights
NanoViricides' NV-387 represents a potentially groundbreaking approach to combating influenza viruses, particularly H5N1. The drug's mechanism of action - mimicking host-side features that viruses consistently require - addresses a critical vulnerability in current antiviral strategies. In preclinical studies, NV-387 demonstrated
The completion of Phase I trials with no adverse events is particularly noteworthy, as safety is often a primary hurdle in antiviral drug development. The broad-spectrum activity against multiple virus families (influenza, coronavirus, RSV, orthopoxviruses) indicates robust therapeutic potential beyond just H5N1.
From a market perspective, NV-387's positioning is strategically significant. Current H5N1 countermeasures face major limitations - vaccines lag behind viral mutations, while existing antivirals (NAIs and PBIs) are showing reduced effectiveness. The global pandemic preparedness market represents a substantial opportunity, particularly for broad-spectrum antivirals that can address multiple threats.
The key differentiator is NV-387's design to prevent viral escape, which could potentially position it as a cornerstone of pandemic preparedness stockpiles. However, the company's small market cap of
The technical approach of targeting sulfated proteoglycans is particularly clever. H5N1's characteristic poly-basic site, which is longer than in seasonal flu strains, should theoretically make it more susceptible to NV-387's mechanism of action. This aligns with established virology principles regarding viral entry mechanisms.
The comparative data showing reduced lung inflammation and mucus production in animal models suggests NV-387 may prevent the progression to severe pneumonia - a critical factor in reducing mortality from highly pathogenic influenza strains. The drug's broad-spectrum activity across different viral families provides strong validation of the underlying mechanism, though Phase II data will be important for confirming these effects in humans.
SHELTON, CT / ACCESSWIRE / December 23, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), says that its broad-spectrum antiviral drug candidate NV-387 is the best weapon to fight a potential bird flu pandemic because the mercurial H5N1 Influenza A virus would not be able to escape the drug.
"Despite all changes, the H5N1 Influenza A virus should remain susceptible to NV-387 because NV-387 mimics the very essential host-side feature that H5N1 continues to use even as it changes," said Anil R. Diwan, Ph.D., President and Executive Chairman of the Company, adding "This drug puts us in a great position to be able to fight a bird flu pandemic should it happen."
WHO has stated "Available virus sequences from human cases [of H5 infection] have shown some genetic markers that may reduce susceptibility to neuraminidase inhibitors (antiviral medicines such as oseltamivir) [NAIs] or endonuclease inhibitors (such as baloxavir marboxil) [PBIs]" in their updated public health assessment of recent Influenza A H5 infections, dated December 20, 2024[1].
NAIs and PBIs[2] are the only classes of drugs that currently exist for influenza treatment, and as the virus evolves, they are very likely to be rendered ineffective in the field, since already strains with reduced susceptibility are circulating.
While the US Government has already sourced and stockpiled two different H5N1 vaccines, the Biden administration has currently no plans to authorize their use.
Influenza viruses change far more rapidly than SARS-CoV-2 ever did in the COVID-19 pandemic[3]. At least one mutation in the H5 coat protein would be required for efficient infection of humans, and a few more changes that would still be required for rapid human-to-human transmission, in order for the H5N1 virus to turn into a pandemic virus; changes that have not happened yet.
Nevertheless, any currently designed H5N1 vaccines are unlikely to be of much use, or possibly very limited use, from public health perspective to protect from a potential pandemic strain of H5N1 that has not appeared yet.
In any case, vaccine against a rapidly changing virus is a game of chasing a rapidly moving target, as we have all learned from the experience during the COVID-19 pandemic[4].
It is thus clear that a drug that the virus cannot escape is the only appropriate tool to fight a potential pandemic.
We have already developed such a drug. NV-387 is a broad-spectrum antiviral that mimics the very host-side features that the virus continues to require no matter how much it changes in the field. It is highly unlikely that a susceptible virus would escape such a drug.
The ultra-broad antiviral spectrum of NV-387, which encompasses a large number of diverse kinds of viruses including COVID, RSV, Influenza and even Orthopoxviruses (i.e. MPox, Smallpox), further substantiates that it is unlikely that a susceptible virus would escape this drug.
What is more, NV-387 has demonstrated substantially superior activity to existing influenza drugs in a lethal lung infection animal study, as we have previously reported (reproduced below):
Survival Lifespan of Lethally Infected Mice - Lung Infection with Influenza A H3N2 | |||
|---|---|---|---|
Treatment | Survival, Days | Increase in Survival, Days | Increase in Survival, % |
NV-387, Oral | 15 | 7 | |
Oseltamivir, Oral | 10 | 2 | |
Peramivir, I.V. | 11 | 3 | |
Baloxivir, Oral | 11 | 3 | |
Vehicle | 8 | 0 | |
In this animal study, we also found that NV-387 treatment led to significant lung protection in the infected animals: lung destroying immune cell infiltration was substantially reduced, and the amount of mucus in the lungs was also substantially reduced, indicating that NV-387 protected the lungs and the animal from advancing into pneumonia.
We believe that any H5N1 highly pathogenic virus is likely to be even more susceptible to NV-387 than the seasonal H3N2 influenza A virus. This is because all High-Path Avian Influenza A viruses are known to possess a poly-basic site that is much longer than the corresponding sequence in seasonal influenza viruses. The virus uses this poly-basic site to bind to sulfated proteoglycans prior to entry into cells. NV-387 displays a copious amount ligands that mimic this sulfated structure, which is how this drug (NV-387) entraps the virus. Thus a longer poly-basic site would be expected to cause a stronger interaction between the H5N1 High Path viruses and NV-387 in contrast to the interaction between NV-387 and seasonal influenza viruses.
NV-387 has completed a Phase I human clinical trial with no reported adverse events and no drop-outs, indicating excellent safety and tolerability. We are now preparing for a Phase II clinical trial for the treatment of MPox which is currently an epidemic in Central Africa. We are also working on a Phase II clinical trial of NV-387 for the treatment of respiratory virus infections (including Influenza viruses, Coronaviruses, and RSV, among others).
Thus we believe that we are in a strong position to combat a potential bird flu pandemic, being one of very few companies globally that is developing a broad-spectrum antiviral drug with the promise that viruses would be highly unlikely to escape the drug.
[2] NAIs = Neuraminidase inhibitors. These include Oseltamivir (Tamiflu®), Peramivir (Rapivab®), Zanamivir (Relenza®). They inhibit the exit of the virus particle from cell after the virus has already replicated into copious quantities inside the cell. PBIs = Viral Polymerase (B) inhibitors. Currently only Baloxavir (Xofluza) is licensed. They inhibit the production of new copies of viral genomic RNA. However, resistant virus to baloxavir was created in patients treated with baloxavir in its clinical trial itself. Further, the toxicity of this drug limits its use to a single dose.
[3] Influenza viruses change very rapidly because they have many more tools to change themselves compared to other viruses. Firstly, an influenza virus is made up of eight separate segments of RNA, that it can simply swap with other influenza viruses (called "Re-assortment"). Secondly, segments of RNA can hop from one RNA to another (Called "Recombination"), and thirdly, single point mutations occur all the time across the entire RNA, because the virus lacks "proof-reading" capability (i.e. ability to ensure that the RNA is copied correctly).
[4] The COVID vaccines did not protect the vaccinated from getting sick, and they did not even stop the vaccinated from transmitting the virus to others. The benefit of vaccination is thought to be in persons with other morbidities who would have been likely to contract severe disease from infection with hospitalization and possible death. However, the vaccines always lagged behind in time, developed against a strain that was already overtaken by a different one in the field even before rollout of the vaccine.
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 plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, 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.
NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
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 are the survival rate improvements of NNVC's NV-387 compared to existing flu treatments?
What clinical trial phase is NNVC's NV-387 currently in as of December 2024?
How does NNVC's NV-387 work against H5N1 bird flu?
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Why does NNVC claim NV-387 could be more effective against H5N1 than seasonal flu?
