There is a Strong Business Case for Phase II Clinical Program for Treatment of MPox Infection Using NV-387, an Industry-Leading Broad-Spectrum Antiviral Drug Candidate
NanoViricides (NYSE Amer.:NNVC) has announced plans to advance its lead drug candidate NV-387 into Phase II clinical trials, initially focusing on MPox treatment. The company has already secured a Clinical Trial Site in the Democratic Republic of Congo (DRC) and is finalizing the trial protocol.
The strategic decision to prioritize MPox is driven by several factors: the ongoing epidemic in Africa enabling timely patient recruitment, lower clinical trial costs compared to US/Europe trials, and potential inclusion in the US Strategic National Stockpile (SNS). The company notes that current approved drugs for smallpox treatment, tecovirimat (Tpoxx) and brincidofovir (Tembexa), have shown limitations in MPox treatment.
NanoViricides has developed "NV-387 Oral Gummies" as the drug delivery format, specifically designed for MPox patients who may have difficulty swallowing due to mucosal lesions. The drug substance manufacture is substantially completed at the company's facility, with drug product manufacturing in progress.
NanoViricides (NYSE Amer.:NNVC) ha annunciato l'intenzione di portare il suo principale candidato farmaco NV-387 alla fase II degli studi clinici, concentrandosi inizialmente sul trattamento della MPox. L'azienda ha già ottenuto un sito per la sperimentazione clinica nella Repubblica Democratica del Congo (RDC) e sta ultimando il protocollo dello studio.
La decisione strategica di dare priorità alla MPox è motivata da diversi fattori: l'epidemia in corso in Africa che consente un rapido reclutamento di pazienti, costi degli studi clinici inferiori rispetto a quelli negli Stati Uniti o in Europa, e la possibile inclusione nello Strategic National Stockpile (SNS) degli Stati Uniti. L'azienda sottolinea che i farmaci attualmente approvati per il trattamento del vaiolo, tecovirimat (Tpoxx) e brincidofovir (Tembexa), hanno mostrato limiti nel trattamento della MPox.
NanoViricides ha sviluppato le "NV-387 Oral Gummies" come formato di somministrazione del farmaco, specificamente pensate per i pazienti con MPox che potrebbero avere difficoltà a deglutire a causa delle lesioni mucose. La produzione della sostanza farmaceutica è sostanzialmente completata presso la struttura dell'azienda, mentre la produzione del prodotto farmaceutico è in corso.
NanoViricides (NYSE Amer.:NNVC) ha anunciado planes para avanzar con su candidato principal NV-387 hacia ensayos clínicos de Fase II, enfocándose inicialmente en el tratamiento de MPox. La compañía ya ha asegurado un sitio para el ensayo clínico en la República Democrática del Congo (RDC) y está finalizando el protocolo del estudio.
La decisión estratégica de priorizar MPox se basa en varios factores: la epidemia en curso en África que permite un reclutamiento oportuno de pacientes, costos de ensayos clínicos más bajos en comparación con EE.UU./Europa, y la posible inclusión en el US Strategic National Stockpile (SNS). La compañía señala que los medicamentos aprobados actualmente para el tratamiento de la viruela, tecovirimat (Tpoxx) y brincidofovir (Tembexa), han mostrado limitaciones en el tratamiento de MPox.
NanoViricides ha desarrollado las "NV-387 Oral Gummies" como formato de administración del medicamento, diseñadas específicamente para pacientes con MPox que podrían tener dificultades para tragar debido a lesiones mucosas. La fabricación de la sustancia activa está prácticamente terminada en las instalaciones de la compañía, y la producción del producto farmacéutico está en proceso.
NanoViricides (NYSE Amer.:NNVC)는 주력 약물 후보인 NV-387을 2상 임상시험으로 진입시키기 위한 계획을 발표했으며, 초기에는 MPox 치료에 집중할 예정입니다. 회사는 이미 콩고민주공화국(DRC)에 임상시험 사이트를 확보했으며, 시험 프로토콜을 마무리하고 있습니다.
MPox를 우선시하는 전략적 결정은 여러 요인에 기반합니다: 아프리카에서 진행 중인 유행병으로 환자 모집이 신속하게 이루어질 수 있고, 미국/유럽에 비해 임상시험 비용이 낮으며, 미국 전략 국가 비축고(SNS)에 포함될 가능성도 있기 때문입니다. 회사는 현재 승인된 천연두 치료제인 테코비리마트(Tpoxx)와 브린시도포비르(Tembexa)가 MPox 치료에는 한계가 있음을 지적했습니다.
NanoViricides는 MPox 환자들이 점막 병변으로 인해 삼키기 어려울 수 있다는 점을 고려하여 "NV-387 구강용 젤리"를 약물 투여 형태로 개발했습니다. 약물 원료 제조는 회사 시설에서 대부분 완료되었으며, 약물 제품 제조가 진행 중입니다.
NanoViricides (NYSE Amer.:NNVC) a annoncé son intention de faire progresser son principal candidat médicament NV-387 vers les essais cliniques de phase II, en se concentrant initialement sur le traitement de la MPox. La société a déjà sécurisé un site d'essai clinique en République démocratique du Congo (RDC) et finalise le protocole de l'étude.
La décision stratégique de prioriser la MPox est motivée par plusieurs facteurs : l'épidémie en cours en Afrique permettant un recrutement rapide des patients, des coûts d'essais cliniques inférieurs par rapport aux États-Unis/Europe, et une possible inclusion dans le US Strategic National Stockpile (SNS). La société note que les médicaments actuellement approuvés pour le traitement de la variole, le tecovirimat (Tpoxx) et le brincidofovir (Tembexa), présentent des limites dans le traitement de la MPox.
NanoViricides a développé les "NV-387 Oral Gummies" comme forme d'administration du médicament, spécialement conçues pour les patients atteints de MPox qui pourraient avoir des difficultés à avaler en raison de lésions muqueuses. La fabrication de la substance médicamenteuse est pratiquement terminée dans les installations de la société, tandis que la production du produit pharmaceutique est en cours.
NanoViricides (NYSE Amer.:NNVC) hat Pläne angekündigt, seinen führenden Wirkstoffkandidaten NV-387 in die Phase-II-Studien zu bringen, mit anfänglichem Fokus auf die Behandlung von MPox. Das Unternehmen hat bereits einen Studienstandort in der Demokratischen Republik Kongo (DRK) gesichert und finalisiert das Studienprotokoll.
Die strategische Entscheidung, MPox zu priorisieren, basiert auf mehreren Faktoren: die andauernde Epidemie in Afrika ermöglicht eine zeitnahe Patientenrekrutierung, die klinischen Studienkosten sind niedriger als in den USA/Europa, und eine mögliche Aufnahme in den US Strategic National Stockpile (SNS). Das Unternehmen weist darauf hin, dass die derzeit zugelassenen Medikamente zur Behandlung von Pocken, Tecovirimat (Tpoxx) und Brincidofovir (Tembexa), Einschränkungen bei der Behandlung von MPox aufweisen.
NanoViricides hat "NV-387 Oral Gummies" als Darreichungsform entwickelt, speziell für MPox-Patienten, die aufgrund von Schleimhautläsionen Schwierigkeiten beim Schlucken haben könnten. Die Herstellung des Wirkstoffs ist am Standort des Unternehmens weitgehend abgeschlossen, die Produktion des Arzneimittels läuft derzeit.
- Clinical trial site secured in DRC with protocol in final stages
- Drug substance NV-387 manufacturing substantially completed at company facility
- Potential for significant SNS contracts, with recent comparable deals exceeding $150 million
- Strategic advantages of MPox program include lower trial costs and faster path to revenue
- Novel gummy formulation specifically designed for MPox patient needs
- Multiple regulatory approvals still required before commercialization
- Dependence on external collaborators and consultants may affect timeline
- Competition from existing approved drugs in the market
- No guaranteed timeline for IND filing
Insights
NanoViricides' advancement of NV-387 to Phase II for MPox creates strategic pathway to potential government contracts worth $150M+.
NanoViricides is making a calculated strategic move by prioritizing MPox as the first indication for their broad-spectrum antiviral NV-387, rather than pursuing respiratory indications first. This decision reveals a clever regulatory and commercial strategy that leverages several key advantages.
The company's selection of MPox creates a three-fold strategic benefit: 1) Patient recruitment feasibility in ongoing African epidemic regions, 2) Human efficacy validation of their animal models, and 3) A clear path to significant government contracts.
The competitive landscape has unexpectedly improved for NanoViricides following the clinical failures of both FDA-approved smallpox treatments (tecovirimat/Tpoxx and brincidofovir/Tembexa) against MPox. These drugs were approved under the FDA Animal Rule without human efficacy data and subsequently acquired for the Strategic National Stockpile (SNS) for billions of dollars.
Their "NV-387 Oral Gummies" formulation demonstrates thoughtful clinical consideration for MPox patients who develop painful oral lesions that make swallowing difficult. The company has strategically targeted Clade 1a/1b MPox virus strains found in Africa, which have substantially higher case fatality rates (1-11% CFR) compared to the milder Clade 2b circulating in Western countries.
The business strategy appears focused on securing lucrative government contracts for bioterrorism preparedness, with recent BARDA contracts for tecovirimat exceeding $150 million. The company believes an initial stocking contract for NV-387 could be "substantially larger" if their Phase II trial demonstrates efficacy.
Importantly, NanoViricides' technology platform may offer advantages against potential bioterrorism threats since their nanomedicine approach might be less susceptible to viral escape mutations compared to small molecule drugs like tecovirimat and brincidofovir.
NanoViricides targets lucrative government biodefense contracts by addressing critical MPox/smallpox treatment gaps left by failed competitors.
NanoViricides' strategic pivot toward MPox as their lead indication for NV-387 directly targets a significant market opportunity in biodefense contracting. The company has identified a critical vulnerability in the current Strategic National Stockpile (SNS) after both existing FDA-approved smallpox treatments – tecovirimat (TPOXX) and brincidofovir (Tembexa) – demonstrated clinical failures against MPox.
This creates an unusual situation where the government has invested billions in stockpiling drugs with questionable real-world effectiveness. The failure of tecovirimat to show superiority over standard care in MPox trials creates an immediate opportunity for NanoViricides to position NV-387 as the replacement candidate for future procurement cycles.
The company's technology platform offers a compelling advantage in the biodefense space. Their nanomedicine approach, which they describe as "host-mimetic" technology that "viruses cannot escape," directly addresses concerns about potential engineered bioweapon resistance to conventional antivirals. This feature is particularly valuable for smallpox preparedness, where a bioterrorism agent could theoretically be manipulated to resist existing countermeasures.
The financial implications are substantial, with recent BARDA replenishment contracts for tecovirimat exceeding $150 million. NanoViricides correctly identifies that initial stocking contracts typically command premium pricing compared to replenishment cycles, suggesting a potentially larger initial procurement value.
By conducting trials in the Democratic Republic of Congo where active Clade 1 MPox transmission is occurring, the company has designed a capital-efficient development pathway. This approach allows them to generate human efficacy data against the more virulent MPox strains (3-11% case fatality rate) at substantially lower clinical trial costs compared to their planned respiratory virus programs in the US and Europe.
SHELTON, CT / ACCESS Newswire / July 1, 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, announces that it is forging ahead with advancing its lead candidate NV-387 into Phase II clinical drug development.
NanoViricides has chosen MPox as the first indication to advance NV-387 into Phase II clinical trials out of the four indications for which the Company has substantial efficacy data in animal studies, namely RSV, Influenza, COVID, and Orthopoxviruses (MPox/Smallpox).
The MPox program enables advancing its pipeline towards revenue in the fastest possible manner, the Company believes. The Company intends to advance NV-387 against respiratory infections soon after the Phase II clinical trial of NV-387 for the treatment of MPox infection gets under way.
NanoViricides has already added one Clinical trial Site to the MPox Phase II Program.
A Phase II Clinical Trial Protocol has been developed with the Principal Investigator at this site in the Democratic Republic of Congo (DRC), and this Protocol is undergoing final refinements.
A Clinical Trial Application is in development with many parts having been substantially completed.
NanoViricides has engaged a Clinical Research Organization (CRO) to organize and conduct this Phase II clinical trial for the treatment of MPox with NV-387, as previously stated, and this CRO has organized the Clinical Trial Site and is preparing the CTA with the Company's inputs.
The manufacture of the drug substance NV-387 is substantially completed at the Company's own facility. The manufacture of the drug product "NV-387 Oral Gummies" is in progress.
MPox as the first indication has several strategic benefits for the Company.
Firstly, because of the continuing epidemic in the African Region there is a strong need for the drug and also there is the ability to recruit patients and complete the clinical trial in a timely manner. Additionally, running clinical trials in the African Region is substantially less expensive than clinical trials in USA or Europe that the Company has planned for RSV, a commercially important indication with multi-billion dollar potential market.
Secondly, a proof of efficacy in humans of NV-387 against MPox would validate our use of lethal challenge animal models and would establish that our animal model data are predictive of human outcomes. This would have huge implications since our animal model data against every infection we have tested to date has demonstrated NV-387 to be substantially superior to existing drugs, viz. RSV, Influenza, COVID, and of course, MPox/Smallpox.
Thirdly, there is a strong financial case for choosing MPox as the indication. This business case has become even stronger with the failure of tecovirimat (Tpoxx) in clinical trial against MPox. Tecovirimat and brincidofovir (Tembexa) are the only two drugs approved by the US FDA for the treatment of Smallpox, a virus of bioterrorism concern. Both of these drugs were approved under the "FDA Animal Rule", which eliminates the need for demonstration of efficacy in humans. The "FDA Animal Rule" is applicable for diseases such as Smallpox and others where clinical trials in human patients are not feasible or would be unethical.
These FDA approvals have led to the acquisition of these two drugs into the US Strategic National Stockpile (SNS) to the tune of billions of dollars. And now, there is a clear need for replacing these non-performing drugs with a drug that actually works against MPox and Smallpox (see further down below).
We believe NV-387 would become the choice for addition to the SNS if our proposed Phase II clinical trial against MPox demonstrates benefits of the NV-387 treatment.
The most recent acquisition contracts with BARDA for tecovirimat, which were for drug replenishments, have been valued at over
An initial stocking contract for NV-387 is likely to be substantially larger, as was the case with the initial acquisition of several drugs into the SNS.
Brincidofovir failed an early clinical trial against MPox due to liver toxicity. Tecovirimat failed a recent clinical trial against MPox since it demonstrated no superiority in efficacy over the standard of care.
Importantly, both of these drug candidates are small chemicals that the viruses can readily escape by mutations. Smallpox, if it ever becomes fielded as a bio-terrorism agent, is unlikely to be in the "original" form of the virus, and could be explicitly manipulated to breed resistance to such small chemical drugs by onerous entities.
Of note, MPox is in the same family as the Smallpox virus; MPox causes a much weaker form of disease than the Smallpox virus.
Thus there is a strong case for HHS to support NV-387 drug development for Bioterrorism Readiness.
The "NV-387 Oral Gummies" drug product is a soft solid formulation that is designed to stick in the oral cavity and dissolve naturally over time, with no solid object (pill or capsule) swallowing necessary. This is important for MPox because MPox causes lesions on mucosal surfaces that make swallowing painful and difficult. MPox is primarily known for the explicit characteristic painful rash on the external skin, but it is a significantly more severe disease than just a skin rash.
The MPox virus circulating in DRC and neighboring regions is of Clade 1a and Clade 1b subtypes, with the latter predominant. Clade 1b is more transmissible of the two, which is why it has resulted in a sustained epidemic. The MPox Clade 1a case fatality rate (CFR) is about
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
What is NanoViricides' (NNVC) plan for NV-387 clinical trials?
Why did NNVC choose MPox as the first indication for NV-387?
What advantages does NNVC's NV-387 have over existing MPox treatments?
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How is NNVC's NV-387 drug manufactured and formulated?
What other indications is NNVC planning to pursue with NV-387?
