NanoViricides Engages CRO for Phase II Clinical Trial
NanoViricides (NYSE:NNVC) has engaged a Clinical Research Organization to conduct a Phase II clinical trial for its broad-spectrum antiviral drug NV-387, focusing on MPox treatment. The development comes as MPox disease caused a regional pandemic in African countries, leading to WHO declaring a Public Health Emergency in August 2024.
NV-387 has demonstrated strong antiviral activity against orthopoxviruses, matching the effectiveness of tecovirimat in both skin and lung infection models. Unlike tecovirimat, which failed its clinical trial, NV-387's host-mimetic mechanism makes viral escape highly unlikely. The drug has shown promising results in treating RSV and was found superior to existing treatments in influenza models.
NanoViricides (NYSE:NNVC) ha incaricato un'organizzazione di ricerca clinica di condurre un trial clinico di Fase II per il suo farmaco antivirale a largo spettro NV-387, focalizzandosi sul trattamento dell'MPox. Questo sviluppo arriva dopo che la malattia MPox ha causato una pandemia regionale nei paesi africani, conducendo l'OMS a dichiarare un'emergenza sanitaria pubblica nell'agosto del 2024.
NV-387 ha dimostrato una forte attività antivirale contro gli orthopoxvirus, paragonabile all'efficacia del tecovirimat sia nei modelli di infezione cutanea che polmonare. A differenza del tecovirimat, che ha fallito il suo trial clinico, il meccanismo mimetico dell'ospite di NV-387 rende altamente improbabile l'adeguamento virale. Il farmaco ha mostrato risultati promettenti nel trattamento del RSV ed è stato considerato superiore ai trattamenti esistenti nei modelli di influenza.
NanoViricides (NYSE:NNVC) ha contratado a una Organización de Investigación Clínica para llevar a cabo un ensayo clínico de Fase II para su medicamento antiviral de amplio espectro NV-387, centrándose en el tratamiento del MPox. Este desarrollo se produce tras la pandemia regional de la enfermedad MPox en países africanos, lo que llevó a la OMS a declarar una Emergencia de Salud Pública en agosto de 2024.
NV-387 ha demostrado una fuerte actividad antiviral contra los orthopoxvirus, igualando la efectividad del tecovirimat tanto en modelos de infección cutánea como pulmonar. A diferencia del tecovirimat, que fracasó en su ensayo clínico, el mecanismo mimético del huésped de NV-387 hace que la escape viral sea muy improbable. El medicamento ha mostrado resultados prometedores en el tratamiento del RSV y se ha encontrado superior a los tratamientos existentes en modelos de influenza.
NanoViricides (NYSE:NNVC)는 2상 임상 시험을 진행하기 위해 임상 연구 기관을 고용하여 광범위 항바이러스 약물 NV-387의 MPox 치료에 집중하고 있습니다. 이 개발은 MPox 질병이 아프리카 국가에서 지역적인 팬데믹을 일으킨 이후에 이루어졌으며, 이에 따라 WHO는 2024년 8월에 공공 보건 비상사태를 선언했습니다.
NV-387은 orthopoxvirus에 대해 강력한 항바이러스 활성을 보여주며, 피부 및 폐 감염 모델에서 tecovirimat의 효과와 일치합니다. tecovirimat이 임상 시험에서 실패한 것과 달리, NV-387의 숙주 모방 메커니즘은 바이러스의 변이를 매우 어렵게 만듭니다. 이 약물은 RSV 치료에서 유망한 결과를 보였으며, 인플루엔자 모델에서는 기존 치료법보다 우수한 것으로 평가되었습니다.
NanoViricides (NYSE:NNVC) a engagé une Organisation de Recherche Clinique pour mener un essai clinique de phase II pour son médicament antiviral à large spectre NV-387, axé sur le traitement de l'MPox. Ce développement intervient après que la maladie MPox a provoqué une pandémie régionale dans des pays africains, ce qui a conduit l'OMS à déclarer une Urgence de Santé Publique en août 2024.
NV-387 a démontré une forte activité antivirale contre les orthopoxvirus, égalant l'efficacité du tecovirimat à la fois dans des modèles d'infection cutanée et pulmonaire. Contrairement au tecovirimat, qui a échoué dans son essai clinique, le mécanisme mimétique de l'hôte de NV-387 rend l'évasion virale très peu probable. Le médicament a montré des résultats prometteurs dans le traitement du RSV et a été jugé supérieur aux traitements existants dans des modèles de grippe.
NanoViricides (NYSE:NNVC) hat eine klinische Forschungsorganisation beauftragt, eine Phase-II-Studie für sein antivirales Breitbandmittel NV-387 durchzuführen, das sich auf die Behandlung von MPox konzentriert. Diese Entwicklung erfolgt, nachdem die MPox-Krankheit in afrikanischen Ländern eine regionale Pandemie verursacht hat, was dazu führte, dass die WHO im August 2024 einen Gesundheitsnotstand ausgerufen hat.
NV-387 hat eine starke antivirale Aktivität gegen Orthopoxviren gezeigt, die mit der Wirksamkeit von Tecovirimat in Haut- und Lungeninfektionsmodellen übereinstimmt. Im Gegensatz zu Tecovirimat, das in seiner klinischen Studie gescheitert ist, macht der wirtsnachahmende Mechanismus von NV-387 eine virale Flucht äußerst unwahrscheinlich. Das Medikament hat vielversprechende Ergebnisse bei der Behandlung von RSV gezeigt und war in Influenza-Modellen überlegen gegenüber bestehenden Behandlungen.
- Advancement to Phase II clinical trials for NV-387
- Strong antiviral activity demonstrated in orthopoxvirus models
- Superior effectiveness compared to existing influenza treatments
- Unique host-mimetic mechanism reducing viral escape risk
- No exact IND filing date projected due to external dependencies
- Lengthy drug development process requiring substantial capital
- No current assurance of sufficient effectiveness and safety for human clinical development
Insights
The advancement of NV-387 into Phase II trials marks a important inflection point for NanoViricides, particularly given the current landscape of antiviral therapeutics. The timing is especially significant as it coincides with the WHO's August 2024 PHEIC declaration for MPox, creating a clear market opportunity.
The drug's competitive positioning is compelling for several reasons:
- Recent government contracts totaling
$121.5 million awarded to SIGA for TPOXX, despite its clinical trial failure, demonstrate strong institutional demand for effective MPox treatments - NV-387's host-mimetic mechanism targeting sulfated proteoglycans presents a fundamental advantage over existing antivirals, as it's significantly more difficult for viruses to develop resistance
- Demonstrated efficacy in both direct skin and lung infection models matches TPOXX's effectiveness, while offering broader application potential
The market opportunity extends beyond MPox, as NV-387 has shown promise against RSV, influenza and other respiratory viruses. This broad-spectrum potential could position it as a important addition to national strategic stockpiles and pandemic preparedness programs.
However, investors should note several critical factors:
- The company's relatively small market cap suggests potential need for additional funding to support Phase II trials
- While the mechanism of action is promising, Phase II trials will be important in validating human efficacy
- The regulatory pathway may be expedited given the public health need, but timeline to potential approval remains uncertain
The engagement of a CRO signals operational progress and suggests confidence in the drug's potential, but careful monitoring of trial progress and cash runway will be essential for investors.
SHELTON, CT / ACCESS Newswire / January 27, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") today announced that it has engaged a Clinical Research Organization (CRO) to conduct a Phase II clinical trial advancing its broad-spectrum antiviral drug NV-387 further into the regulatory pipeline.
"NV-387, our broad-spectrum antiviral drug is poised to cause a revolution in treatment of viral diseases, just as antibiotics revolutionized the treatment of bacterial diseases," said Anil R. Diwan, Ph.D., further commenting, "Our regulatory development strategy for this drug is now further advancing into a Phase II clinical trial stage."
The Company has previously stated that it is working towards a Phase II clinical trial to evaluate the effectiveness of NV-387 for the treatment of MPox patients. MPox disease, caused by the human Mpox virus (hMPXV) has been causing a regional pandemic encompassing several countries in the African region, including the Democratic Republic of Congo (DRC), Uganda, and others. It led to the WHO declaring a Public Health Emergency of International Concern ("PHEIC") on August 14, 2024.
There is no drug available for the treatment of hMPXV infection that causes the MPox disease. A clinical trial of tecovirimat (TPOXX®, SIGA) failed to demonstrate any effectiveness over placebo, as per a NIH press release on August 15, 2024.
In July 2024, SIGA received a procurement order for
"These desperate attempts by the Previous US Administration to acquire an ineffective drug with hundreds of millions of dollars of taxpayer money only go to show how sorely a truly effective antiviral drug that works against MPox/Smallpox is needed by the government agencies," commented Anil R. Diwan, PhD, President and Executive Chairman of the Company.
NV-387 was found to possess strong antiviral activity against an orthopoxvirus in an animal model that is considered an important model to establish potential effectiveness against MPox and Smallpox viruses, as all of these viruses belong to the same family of orthopoxviruses.
In fact, NV-387 effectiveness matched the effectiveness of the small chemical drug tecovirimat in two different models of infection, one was direct skin infection, and the other was a direct lung infection, by the virus.
Escape of virus from tecovirimat can occur by a single point mutation in a viral protein called VP-37.
In contrast, viruses are highly unlikely to escape NV-387 because no matter how much the virus changes in the field, it continues to use sulfated proteoglycans such as HSPG as "attachment receptor" in order to cause cell infection. NV-387 mimics the sulfated proteoglycan signature feature that the viruses require.
NV-387 is host-mimetic drug that "looks like a cell" to the virus, displaying numerous ligands that mimic the sulfated proteoglycan, enticing the virus to bind to and become engulfed by the NV-387 dynamic shape-shifting polymeric micelle.
Vaccines, antibodies, and small chemical drugs such as tecovirimat for MPox/Smallpox, or oseltamivir (Tamiflu®), baloxavir (Xofluza®) for Influenza are readily escaped by viruses wirth small changes that viruses undergo as they are faced with these challenges in the field.
Therefore development of NV-387, a broad-spectrum host-mimetic, direct-acting antiviral drug that the viruses cannot escape even as they change constantly, will be revolutionary once the drug undergoes regulatory development for approval for use in humans.
NV-387 has already been found to be able to cure lethally RSV infected mice.
NV-387 was found to be significantly superior to oseltamivir (Tamiflu®), baloxavir (Xofluza®), and premivir (Rapivab®) in a lethal Influenza lung infection model designed to rank-order the effectiveness of these various drugs.
New viruses and existing viruses acquiring greater pathology and infectivity are bound to keep appearing in time. To combat such threats, we need to develop broad-spectrum drug arsenal that the viruses cannot escape. Vaccines and antibodies simply will not do, as their limitations have become clearly evident during the COVID-19 pandemic.
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.
Where stated with an ® , the name is a registered trademark, which belongs to the owner of the trademark name.
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.
View the original press release on ACCESS Newswire
FAQ
What is the purpose of NNVC's Phase II clinical trial for NV-387?
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What advantages does NNVC's NV-387 show over tecovirimat (TPOXX)?
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