COVID is Here to Stay and NV-387 is a Much Needed Drug Against It, Reminds NanoViricides
NanoViricides (NYSE American:NNVC) reminds investors of the strong safety and effectiveness of its lead drug candidate NV-387 against coronaviruses. The company highlights the need for effective COVID-19 treatments, as new variants continue to emerge. Animal studies show NV-387 outperforming remdesivir, with a 180% improvement in survival rates for intravenous treatment and 88% for oral formulation.
NV-387 has completed a Phase I human clinical trial in India, demonstrating excellent safety and tolerability. The drug shows broad antiviral spectrum, potentially effective against coronaviruses, RSV, influenza, and poxviruses. NanoViricides is now seeking collaborations with pharmaceutical companies to advance NV-387 towards regulatory approvals for multiple antiviral indications.
NanoViricides (NYSE American:NNVC) ricorda agli investitori l'ottima sicurezza e l'efficacia del suo principale candidato farmaceutico NV-387 contro i coronavirus. L'azienda sottolinea la necessità di trattamenti efficaci per il COVID-19, poiché continuano a emergere nuove varianti. Gli studi sugli animali mostrano che NV-387 supera remdesivir, con un miglioramento del 180% nei tassi di sopravvivenza per il trattamento endovenoso e dell'88% per la formulazione orale.
NV-387 ha completato un trial clinico di Fase I in India, dimostrando eccellente sicurezza e tollerabilità. Il farmaco mostra un ampio spettro antivirale, potenzialmente efficace contro i coronavirus, RSV, influenza e poxvirus. NanoViricides sta ora cercando collaborazioni con aziende farmaceutiche per far progredire NV-387 verso l'approvazione normativa per molteplici indicazioni antivirali.
NanoViricides (NYSE American:NNVC) recuerda a los inversores la sólida seguridad y efectividad de su principal candidato a fármaco NV-387 contra los coronavirus. La compañía destaca la necesidad de tratamientos efectivos para el COVID-19, ya que continúan surgiendo nuevas variantes. Los estudios en animales muestran que NV-387 supera al remdesivir, con una mejora del 180% en las tasas de supervivencia para el tratamiento intravenoso y del 88% para la formulación oral.
NV-387 ha completado un ensayo clínico en Fase I en India, demostrando una excelente seguridad y tolerabilidad. El medicamento muestra un amplio espectro antiviral, potencialmente efectivo contra los coronavirus, RSV, influenza y poxvirus. NanoViricides ahora busca colaboraciones con compañías farmacéuticas para avanzar en NV-387 hacia aprobaciones regulatorias para múltiples indicaciones antivirales.
NanoViricides (NYSE American:NNVC)는 투자자들에게 자사의 주요 약물 후보 NV-387가 코로나바이러스에 대해 강력한 안전성과 효과를 가지고 있음을 상기시킵니다. 회사는 새로운 변종이 계속해서 등장함에 따라 효과적인 COVID-19 치료제의 필요성을 강조합니다. 동물 연구에서는 NV-387가 렘데시비르를 초과하여 정맥 주사 치료의 생존율이 180% 향상되었고 경구 제형에서는 88% 향상된 결과를 보여주고 있습니다.
NV-387는 인도에서 1상 임상 시험을 완료하여 우수한 안전성과 내약성을 입증했습니다. 이 약물은 광범위한 항바이러스 스펙트럼을 보여주며, 코로나바이러스, RSV, 인플루엔자 및 폭스바이러스에 대해 잠재적으로 효과적입니다. NanoViricides는 여러 항바이러스 적응증에 대한 규제 승인을 추진하기 위해 제약회사와의 협력을 모색하고 있습니다.
NanoViricides (NYSE American:NNVC) rappelle aux investisseurs la forte sécurité et l'efficacité de son principal candidat médicament NV-387 contre les coronavirus. L'entreprise souligne le besoin de traitements efficaces contre le COVID-19, alors que de nouvelles variantes continuent d'apparaître. Des études sur des animaux montrent que NV-387 dépasse le remdesivir, avec une amélioration de 180% des taux de survie pour le traitement intraveineux et de 88% pour la formulation orale.
NV-387 a terminé un essai clinique de phase I en Inde, démontrant une excellente sécurité et tolérance. Le médicament présente un large spectre antiviral, potentiellement efficace contre les coronavirus, le RSV, la grippe et les poxvirus. NanoViricides recherche désormais des collaborations avec des entreprises pharmaceutiques pour faire avancer NV-387 vers les approbations réglementaires pour plusieurs indications antivirales.
NanoViricides (NYSE American:NNVC) erinnert die Investoren an die starke Sicherheit und Wirksamkeit seines Hauptkandidaten NV-387 gegen Coronaviren. Das Unternehmen hebt den Bedarf an effektiven COVID-19-Behandlungen hervor, da weiterhin neue Varianten auftreten. Tierversuche zeigen, dass NV-387 remdesivir übertrifft, mit einer Verbesserung der Überlebensraten um 180% für die intravenöse Behandlung und 88% für die orale Formulierung.
NV-387 hat eine Phase-I-Studie am Menschen in Indien abgeschlossen, die ausgezeichnete Sicherheit und Verträglichkeit demonstriert. Das Medikament zeigt ein breites antivirales Spektrum, das potenziell gegen Coronaviren, RSV, Influenza und Poxviren wirksam ist. NanoViricides sucht nun nach Kooperationen mit Pharmaunternehmen, um NV-387 in Richtung regulatorische Genehmigungen für mehrere antivirale Indikationen voranzubringen.
- NV-387 showed 180% improvement in survival rates compared to remdesivir in animal studies
- Oral formulation of NV-387 demonstrated 88% increase in survival rates in animal studies
- NV-387 completed Phase I human clinical trial with excellent safety and tolerability
- NV-387 shows broad antiviral spectrum, potentially effective against multiple viruses
- None.
Insights
The announcement of NV-387's effectiveness against COVID-19 variants highlights its potential to be a game-changer in antiviral treatment. Animal studies show NV-387 significantly increases survival rates compared to remdesivir, suggesting its superior efficacy. Importantly, NV-387 not only offers an injectable form for severe cases but also an oral formulation for broader use, addressing a significant gap in current treatment options where Paxlovid has shown limited effectiveness.
The safety profile of NV-387, confirmed in Phase I trials in India, is also promising. The absence of adverse events and high tolerability even at high dosages demonstrate its potential for widespread use. Additionally, its broad-spectrum antiviral properties make NV-387 a versatile candidate against multiple respiratory viruses, reducing the likelihood of resistance development.
For retail investors, the key takeaway is that NanoViricides is advancing a potentially highly effective and safe antiviral drug towards regulatory approval. The company's strategy to seek collaborations for Phase II trials indicates a forward-moving trajectory, potentially leading to market introduction and significant returns in the long term.
From a financial perspective, NanoViricides' progress with NV-387 is noteworthy. Effective treatments for COVID-19 remain a critical need and a successful drug launch could capture a substantial market share. Given the demonstrated efficacy and safety in preclinical and early-phase human trials, NV-387 positions NanoViricides as a strong contender in the antiviral market.
The potential collaborations with pharmaceutical companies could expedite regulatory approvals and commercialization, significantly boosting NanoViricides' market valuation. Investors should note the company's broad portfolio, not limited to COVID-19, which diversifies its revenue streams and reduces dependency on a single product success.
However, the inherent risks in drug development, including lengthy approval processes and substantial capital requirements, remain. Investors should weigh these risks against the potential high rewards of a successful NV-387 launch.
The announcement underscores a critical market opportunity for NanoViricides. The COVID-19 pandemic has exposed the need for more effective antiviral treatments, especially as new variants emerge. NV-387's demonstrated effectiveness in animal studies and Phase I human trials positions it as a potential leader in this space.
The unique selling points of NV-387, including its broad-spectrum activity and availability in both injectable and oral forms, address significant unmet needs. The company's focus on regulatory approvals and strategic partnerships further indicates a strong roadmap towards market entry.
For investors, this development is promising, suggesting potential for substantial market penetration and revenue growth. The drug's versatility against various viral infections also implies a wider market applicability, further enhancing its commercial potential.
SHELTON, CT / ACCESSWIRE / July 24, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage global leader in broad-spectrum antiviral nanomedicines, today reminds 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."
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
Survival Lifespan of Lethally Infected Rats - Lung Infection with hCoV-NL63 | |||
Treatment | Survival, Days | Increase in Survival, Days | Increase in Survival, % |
NV-387, I.V. | 14 | 9 | |
Remdesivir, I.V. (Veklury formulation) | 7.5 | 2.5 | |
Vehicle; Untreated | 5 | 0 | - |
We thereafter developed an oral formulation of NV-387 and studied its effect in comparison to the NV-387 I.V. treatment. The results are shown in the Table below:
Survival Lifespan of Lethally Infected Rats - Lung Infection with hCoV-NL63 | |||
Treatment | Survival, Days | Increase in Survival, Days | Increase in Survival, % |
NV-387, I.V. | 16.6 | 8.9 | |
Vehicle Control for I.V. | 7.7 | 0 | - |
NV-387, Oral | 12.8 | 6 | |
Vehicle Control for Oral | 6.8 | 0 | - |
These 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) 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.
We are now seeking collaborations with Pharma companies to bring this remarkable drug, NV-387, towards regulatory approvals for multiple antiviral indications.
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. Our lead drug candidate is NV-387 for the treatment of RSV, COVID-19, Long COVID, Influenza, and other respiratory viral infections. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles (previously referred to as NV-HHV-101). 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 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".
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
ir@nanoviricides.com
SOURCE: NanoViricides, Inc.
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