Measles Cases Are Increasing Globally; MPox Continues to Be a Threat - Broad-Spectrum Antiviral Drug Could Be the Solution
NanoViricides (NYSE:NNVC) is advancing its broad-spectrum antiviral drug NV-387 to combat multiple viral threats. The company is targeting two major opportunities: Measles, where cases have increased 10-fold in Europe with concerning vaccine failure rates, and MPox, which remains a Public Health Emergency of International Concern according to WHO.
The company has initiated an animal efficacy study for Measles and received clearance from DRC's National Ethics Committee to proceed with Phase II Clinical Trial for MPox treatment. NV-387 will be available to licensed physicians for treating Measles cases under FDA's Individual Patient Expanded Access protocol.
Additionally, NanoViricides is developing NV-387 as an "emperic" treatment for respiratory viral infections through a "basket-type" clinical trial targeting All Influenzas, All Coronaviruses, and RSV. The company is also developing NV-HHV-1, a pan-herpesvirus drug targeting infections linked to neurological damage and Alzheimer's disease.
NanoViricides (NYSE:NNVC) sta portando avanti il suo farmaco antivirale ad ampio spettro NV-387 per combattere diverse minacce virali. L'azienda si concentra su due principali opportunità: il Morbillo, con un aumento dei casi di dieci volte in Europa e tassi preoccupanti di fallimento vaccinale, e il MPox, ancora considerato un'emergenza sanitaria pubblica di interesse internazionale secondo l'OMS.
La società ha avviato uno studio di efficacia animale per il Morbillo e ha ottenuto l'approvazione dal Comitato Etico Nazionale della Repubblica Democratica del Congo per procedere con la Fase II della sperimentazione clinica per il trattamento del MPox. NV-387 sarà disponibile per i medici autorizzati per il trattamento dei casi di Morbillo secondo il protocollo di Accesso Espanso Individuale della FDA.
Inoltre, NanoViricides sta sviluppando NV-387 come trattamento "empirico" per le infezioni virali respiratorie attraverso una sperimentazione clinica di tipo "basket" che mira a tutti i virus influenzali, tutti i coronavirus e il RSV. L'azienda sta anche sviluppando NV-HHV-1, un farmaco pan-herpesvirus rivolto alle infezioni associate a danni neurologici e alla malattia di Alzheimer.
NanoViricides (NYSE:NNVC) está avanzando con su medicamento antiviral de amplio espectro NV-387 para combatir múltiples amenazas virales. La compañía se enfoca en dos grandes oportunidades: el Sarampión, donde los casos han aumentado diez veces en Europa con tasas preocupantes de fallo en la vacunación, y MPox, que sigue siendo una Emergencia de Salud Pública de Interés Internacional según la OMS.
La empresa ha iniciado un estudio de eficacia en animales para el Sarampión y obtuvo la aprobación del Comité Nacional de Ética de la RDC para proceder con el Ensayo Clínico de Fase II para el tratamiento de MPox. NV-387 estará disponible para médicos autorizados para tratar casos de Sarampión bajo el protocolo de Acceso Expandido Individual de la FDA.
Además, NanoViricides está desarrollando NV-387 como un tratamiento "empírico" para infecciones virales respiratorias mediante un ensayo clínico tipo "canasta" que apunta a todas las influenzas, todos los coronavirus y el RSV. La compañía también está desarrollando NV-HHV-1, un medicamento pan-herpesvirus dirigido a infecciones vinculadas a daños neurológicos y la enfermedad de Alzheimer.
NanoViricides (NYSE:NNVC)는 광범위 항바이러스제 NV-387을 개발하여 여러 바이러스 위협에 대응하고 있습니다. 회사는 두 가지 주요 기회를 목표로 하고 있습니다: 유럽에서 사례가 10배 증가하고 백신 실패율이 우려되는 홍역과 WHO에 의해 국제적 공중보건 비상사태로 지정된 MPox입니다.
회사는 홍역에 대한 동물 효능 연구를 시작했으며, DRC 국가 윤리위원회로부터 MPox 치료를 위한 2상 임상시험 진행 승인을 받았습니다. NV-387은 FDA의 개별 환자 확대 접근 프로토콜에 따라 홍역 치료를 위해 허가된 의사들에게 제공될 예정입니다.
또한 NanoViricides는 모든 인플루엔자, 모든 코로나바이러스 및 RSV를 대상으로 하는 '바스켓형' 임상시험을 통해 호흡기 바이러스 감염에 대한 '경험적' 치료제로 NV-387을 개발 중입니다. 회사는 신경 손상 및 알츠하이머병과 관련된 감염을 겨냥한 범-헤르페스바이러스 약물 NV-HHV-1도 개발하고 있습니다.
NanoViricides (NYSE:NNVC) fait progresser son médicament antiviral à large spectre NV-387 pour lutter contre plusieurs menaces virales. L'entreprise cible deux opportunités majeures : la rougeole, dont les cas ont été multipliés par dix en Europe avec des taux préoccupants d'échec vaccinal, et le MPox, toujours considéré comme une urgence de santé publique de portée internationale selon l'OMS.
L'entreprise a lancé une étude d'efficacité animale pour la rougeole et a reçu l'autorisation du Comité national d'éthique de la RDC pour procéder à un essai clinique de phase II pour le traitement du MPox. NV-387 sera disponible pour les médecins agréés afin de traiter les cas de rougeole dans le cadre du protocole d'accès élargi individuel de la FDA.
De plus, NanoViricides développe NV-387 comme traitement « empirique » des infections virales respiratoires via un essai clinique de type « panier » ciblant toutes les grippes, tous les coronavirus et le RSV. L'entreprise développe également NV-HHV-1, un médicament pan-herpès ciblant les infections liées aux dommages neurologiques et à la maladie d'Alzheimer.
NanoViricides (NYSE:NNVC) entwickelt sein breit wirksames antivirales Medikament NV-387, um mehrere virale Bedrohungen zu bekämpfen. Das Unternehmen konzentriert sich auf zwei Hauptchancen: Masern, bei denen die Fälle in Europa um das Zehnfache gestiegen sind und besorgniserregende Impfdurchbrüche auftreten, sowie MPox, das laut WHO weiterhin ein öffentliches Gesundheitsnotfall von internationaler Bedeutung ist.
Das Unternehmen hat eine Wirksamkeitsstudie an Tieren für Masern gestartet und die Genehmigung des Nationalen Ethikkomitees der Demokratischen Republik Kongo erhalten, um mit der Phase-II-Studie zur Behandlung von MPox fortzufahren. NV-387 wird lizenzierten Ärzten zur Behandlung von Masernfällen im Rahmen des individuellen erweiterten Zugangsprotokolls der FDA zur Verfügung stehen.
Darüber hinaus entwickelt NanoViricides NV-387 als "empirische" Behandlung für respiratorische Virusinfektionen durch eine "Basket-Typ"-Klinische Studie, die alle Influenzaviren, alle Coronaviren und RSV abdeckt. Das Unternehmen entwickelt außerdem NV-HHV-1, ein pan-Herpesvirus-Medikament, das auf Infektionen abzielt, die mit neurologischen Schäden und Alzheimer-Erkrankungen in Verbindung stehen.
- NV-387 received clearance from DRC's National Ethics Committee for Phase II Clinical Trial for MPox treatment
- Company has its own cGMP manufacturing facility for NV-387 production
- NV-387 will be available to physicians for Measles treatment under FDA's Expanded Access protocol
- Company is developing a broad-spectrum solution for multiple viral threats, targeting large market opportunities
- Potential first-mover advantage as there are no approved drugs for Measles or MPox
- Drug candidates are still in early clinical stages with no proven efficacy in humans yet
- Development path requires substantial capital and time
- Competition from potential future vaccines and treatments
- Success in lab results doesn't guarantee successful clinical trials
Insights
NanoViricides' broad-spectrum antiviral NV-387 advances in trials for measles and MPox amid rising global cases, addressing significant unmet market needs.
NanoViricides is positioning its lead drug candidate NV-387 as a potential solution for multiple viral infections including measles and MPox, both of which are seeing concerning global increases. The timing is particularly strategic, as measles cases have jumped
The company's technology platform uses a host-mimetic nanomedicine approach that viruses allegedly cannot escape - a key differentiator in antiviral development. NV-387 has received ethics committee clearance in the Democratic Republic of Congo for MPox clinical trials, which gives the company a pathway to generate human efficacy data.
What makes this particularly significant is the current complete absence of approved treatments for both measles and MPox. The company notes that TPOXX (tecovirimat) from SIGA failed in MPox clinical trials, leaving an open market opportunity. NanoViricides plans to pursue a "basket-type" clinical trial design for NV-387 against multiple respiratory viruses (influenza, coronaviruses, RSV), which could substantially expand its commercial potential.
The company's in-house cGMP manufacturing capability provides a strategic advantage for both clinical trials and potential emergency use through Individual Patient Expanded Access protocols. This integrated capability reduces dependency on contract manufacturers and could accelerate time-to-market.
From a market perspective, effective antivirals targeting these indications could generate revenues in the
NanoViricides Explains Its Drug Strategy for Combating Viral Infections and Pandemics
SHELTON, CT / ACCESS Newswire / May 14, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, explains its drug development strategy to combat important global viral threats.
Measles outbreaks have continued to expand in the US, and the dramatic ten-fold increase in annual Measles cases in Europe last year indicates that Measles will be here to stay. Measles vaccine failure cases have also been increasing according to the European data, which is an important cause for concern. Vaccination rates are falling in developed countries.
In this global scenario, NV-387, the clinical stage broad-spectrum, host-mimetic antiviral nanomedicine drug could perhaps be the only currently available drug candidate to combat the Measles virus and disease. There is no approved drug for Measles virus infection.
The Company has already initiated the process for conducting an animal efficacy study that would provide an answer to how effective NV-387 would be against Measles virus.
The Company will make NV-387 available to any licensed physicians intending to treat Measles cases under the Individual Patient Expanded Access protocol of the US FDA. The Company has its own cGMP manufacturing facility.
The Company is pleased to state that it is moving forward with the Phase II Clinical Trial Application (CTA) for the evaluation of NV-387 as treatment of MPox in the Domestic Republic of Congo (DRC). The National Ethics Committee of DRC has recently cleared NV-387 as a potential drug candidate that should advance into the clinical trial, enabling the CTA.
MPox is endemic in DRC, and has continued to cause large numbers of cases in the WHO African Region. In April, 2025, the WHO has restated that MPox continues to be a Public Health Emergency of International Concern (PHEIC), a designation it first declared for the MPox epidemic in August, 2024.
This PHEIC is driven by MPox Clade 1a and 1b viruses that are highly pathogenic and highly transmissible. A milder version, MPox Clade 2, caused an epidemic in 2022, and since then became endemic, in certain subsets of populations in the Western World. It is thought that MPox Clade 1a/1b viruses could possibly lead to a wider epidemic including the rest of the world beyond Africa.
There is currently no approved drug for the treatment of MPox infection. A drug, tecovirimat, (TPOXX®, SIGA) failed in clinical trials for the treatment of MPox. TPOXX has been approved for Smallpox in the USA under the FDA "Animal Rule" and continues to be stockpiled by the US Strategic National Stockpile. A broad-spectrum antiviral effective against all orthopoxviruses including MPox and Smallpox is needed.
"NV-387 is a revolutionary antiviral drug that can combat many viral infections," said Anil R. Diwan, PhD, President and Executive Chairman of the Company, "We are advancing it rapidly towards establishing human clinical effectiveness data and regulatory approvals. We believe our MPox and Measles work will enable rapid advancement of the drug, and make a great global impact in large markets fulfilling unmet medical needs."
The Company is also developing NV-387 as an "emperic" treatment of respiratory viral infections. We are developing a clinical protocol for a "basket-type" clinical trial, i.e. evaluating a single drug, namely, NV-387, against many viruses within a single clinical trial.
The focus of this proposed clinical trial will be on All Influenzas, All Coronaviruses, and RSV. If successful, this study would enable NV-387 to be prescribed immediately when a patient presents to the physician with a respiratory infection suspected to be viral, without waiting for test results to determine which viral infection it is.
Additionally, the Company is developing a pan-herpesvirus drug, NV-HHV-1. Herpesvirus infections from HSV-1, HSV-2, VZV, EBV, as well as HHV-6 have been linked to neurological damage that can eventually lead to Alzheimer's disease. An effective drug that can eradicate herpesviruses is an unmet medical need. Such a drug can make a major impact on chronic diseases such as Alzheimer's.
To date, only effective drugs have brought or maintained endemic or circulating viruses under control. There are no vaccines for herpes viruses, HIV or hepatitis C virus. Yet, successful drugs have helped patients to be cured (HCV), or recover from episodes (HSV), or at least maintain healthy lifespan (HIV) without any vaccines.
Market sizes for effective antiviral drugs run into several billions of dollars for each indication. Also, market sizes expand rapidly once an effective drug is introduced.
"NanoViricides is poised to revolutionize how we treat viral infections, just as antibiotics revolutionized treatment of bacterial infections," said Dr. Diwan, adding, "We continue to march forward and strive hard to make this bright future a reality and to make a meaningful impact on public health, chronic diseases, and individual patients."
Measles confirmed cases in the US have surpassed 1,000 already as of May 8th, 2025, across 31 jurisdictions, according to CDC report (https://www.cdc.gov/measles/data-research/index.html) .
Measles cases in Europe were over 35,000 in 2024, an almost ten-fold increase from 2023, according to the annual report of European Center for Disease Prevention and Control (ECDC). Only approximately
The significant Measles vaccine failure rate observed in Europe is alarming, considering that the two-dose vaccine is supposed to be
Given the various causes of vaccine failure, and of vaccine hesitancy, attaining
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) 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.
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
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