WHO Extended Global Emergency Status of MPox Epidemic - Development of Treatment for MPox with NV-387 is Timely, Says NanoViricides
NanoViricides (NYSE:NNVC) has responded to WHO's extension of the MPox Public Health Emergency status by highlighting the development of their drug candidate NV-387. The company is preparing for Phase II clinical trials of NV-387 for MPox treatment, following successful Phase I safety results where the drug showed no adverse events and demonstrated oral availability.
Unlike current treatments Tecovirimat and Brincidofovir, which have shown limitations and safety concerns, NV-387 employs a unique host-mimetic nanomedicine technology that viruses reportedly cannot escape. The drug achieved a No-Observed-Adverse-Event Level at 1,200 mg/kg in animal studies and is formulated as oral gummies suitable for MPox patients with oral lesions.
The company aims to target a multi-billion-dollar global market for poxvirus bioterrorism preparedness, particularly focusing on the US Strategic National Stockpile market upon successful Phase II trials.
NanoViricides (NYSE:NNVC) ha risposto all'estensione dello stato di emergenza sanitaria pubblica per il vaiolo delle scimmie (MPox) da parte dell'OMS, mettendo in evidenza lo sviluppo del loro candidato farmaco NV-387. L'azienda si sta preparando per le sperimentazioni cliniche di Fase II di NV-387 per il trattamento del MPox, dopo i positivi risultati di sicurezza della Fase I, in cui il farmaco non ha mostrato eventi avversi e ha dimostrato la disponibilit脿 orale.
A differenza dei trattamenti attuali Tecovirimat e Brincidofovir, che presentano limitazioni e preoccupazioni di sicurezza, NV-387 utilizza una tecnologia unica di nanomedicina mimetica dell'ospite che i virus non riescono a eludere. Il farmaco ha raggiunto un livello di assenza di eventi avversi osservati a 1.200 mg/kg negli studi su animali ed 猫 formulato in caramelle gommose orali adatte ai pazienti MPox con lesioni orali.
L'azienda punta a un mercato globale da miliardi di dollari per la preparazione contro il bioterrorismo da poxvirus, concentrandosi in particolare sul mercato dello Stockpile Strategico Nazionale degli Stati Uniti, in caso di successo delle sperimentazioni di Fase II.
NanoViricides (NYSE:NNVC) ha respondido a la extensi贸n del estado de emergencia de salud p煤blica por MPox decretado por la OMS, destacando el desarrollo de su candidato a medicamento NV-387. La compa帽铆a se est谩 preparando para los ensayos cl铆nicos de Fase II de NV-387 para el tratamiento de MPox, tras resultados exitosos de seguridad en la Fase I, donde el medicamento no mostr贸 eventos adversos y demostr贸 disponibilidad oral.
A diferencia de los tratamientos actuales Tecovirimat y Brincidofovir, que han mostrado limitaciones y preocupaciones de seguridad, NV-387 emplea una tecnolog铆a 煤nica de nanomedicina mim茅tica del hu茅sped que supuestamente los virus no pueden evadir. El medicamento alcanz贸 un nivel sin eventos adversos observados a 1,200 mg/kg en estudios con animales y est谩 formulado como gomitas orales adecuadas para pacientes con MPox que presentan lesiones orales.
La compa帽铆a apunta a un mercado global multimillonario para la preparaci贸n contra bioterrorismo con poxvirus, enfoc谩ndose especialmente en el mercado del Stockpile Nacional Estrat茅gico de EE.UU. tras el 茅xito en los ensayos de Fase II.
NanoViricides (NYSE:NNVC)電� WHO臧� MPox 瓿奠氤搓贝 牍勳儊靷儨 鞐办灔鞚� 氚滍憸頃橃瀽, 攴鸽摛鞚� 鞎诫 頉勲炒 NV-387 臧滊皽鞚� 臧曥“頄堨姷雼堧嫟. 須岇偓電� NV-387鞚� MPox 旃橂毳� 鞙勴暅 2靸� 鞛勳儊鞁滍棙 欷�牍� 欷戩澊氅�, 1靸� 鞎堨爠靹� 鞁滍棙鞐愳劀 攵�鞛戩毄鞚� 鞝勴榾 鞐嗢棃瓿� 瓴疥惮 韴棳 臧�電レ劚鞚� 鞛呾頄堨姷雼堧嫟.
順勳灛 旃橂鞝滌澑 韰岇綌牍勲Μ毵堩姼鞕� 敫岆Π鞁滊弰韽箘毳搓皜 頃滉硠鞕� 鞎堨爠靹� 氍胳牅毳� 氤挫澊電� 瓴冴臣 雼Μ, NV-387鞚� 氚旍澊霟姢臧� 須岉敿頃� 靾� 鞐嗠嫟瓿� 鞎岆牑歆� 霃呿姽頃� 靾欖＜ 氇癌 雮橂吀鞚橃暯頀� 旮办垹鞚� 靷毄頃╇媹雼�. 鞚� 鞎诫鞚� 霃欕 鞁ろ棙鞐愳劀 1,200 mg/kg鞚� 氍搓磤彀� 攵�鞛戩毄 靾橃鞚� 旮半頄堨溂氅�, 甑皶 氤戨硛鞚� 鞛堧姅 MPox 頇橃瀽鞐愱矊 鞝來暕頃� 瓴疥惮鞖� 鞝るΜ 順曧儨搿� 鞝滌“霅橃棃鞀惦媹雼�.
須岇偓電� 2靸� 鞛勳儊鞁滍棙 靹标车 鞁� 氙戈淡 鞝勲灥 牍勳稌 鞁滌灔鞚� 欷戩嫭鞙茧, 韽 氚旍澊霟姢 靸濍 韰岆煬 雽�牍勲ゼ 鞙勴暅 靾橃嫮鞏� 雼煬 攴滊鞚� 旮�搿滊矊 鞁滌灔鞚� 氇╉憸搿� 頃橁碃 鞛堨姷雼堧嫟.
NanoViricides (NYSE:NNVC) a r茅agi 脿 la prolongation par l'OMS du statut d'urgence de sant茅 publique pour la MPox en mettant en avant le d茅veloppement de leur candidat m茅dicament NV-387. La soci茅t茅 se pr茅pare 脿 des essais cliniques de phase II pour NV-387 dans le traitement de la MPox, apr猫s des r茅sultats positifs de s茅curit茅 en phase I, o霉 le m茅dicament n'a montr茅 aucun effet ind茅sirable et a d茅montr茅 une disponibilit茅 orale.
Contrairement aux traitements actuels Tecovirimat et Brincidofovir, qui pr茅sentent des limites et des pr茅occupations de s茅curit茅, NV-387 utilise une technologie unique de nanom茅decine mim茅tique de l'h么te que les virus ne peuvent apparemment pas 茅chapper. Le m茅dicament a atteint un niveau sans effet ind茅sirable observ茅 脿 1 200 mg/kg lors d'茅tudes animales et est formul茅 sous forme de gommes orales adapt茅es aux patients MPox pr茅sentant des l茅sions buccales.
La soci茅t茅 vise un march茅 mondial de plusieurs milliards de dollars pour la pr茅paration au bioterrorisme li茅 aux poxvirus, en se concentrant particuli猫rement sur le march茅 du Stockpile National Strat茅gique des 脡tats-Unis en cas de succ猫s des essais de phase II.
NanoViricides (NYSE:NNVC) hat auf die Verl盲ngerung des 枚ffentlichen Gesundheitsnotstands f眉r MPox durch die WHO reagiert und die Entwicklung ihres Wirkstoffkandidaten NV-387 hervorgehoben. Das Unternehmen bereitet Phase-II-Studien f眉r NV-387 zur Behandlung von MPox vor, nachdem in Phase I erfolgreiche Sicherheitsdaten erzielt wurden, bei denen das Medikament keine Nebenwirkungen zeigte und oral verf眉gbar war.
Im Gegensatz zu den aktuellen Behandlungen Tecovirimat und Brincidofovir, die Einschr盲nkungen und Sicherheitsbedenken aufweisen, verwendet NV-387 eine einzigartige wirtsimitierende Nanomedizintechnologie, der Viren offenbar nicht entkommen k枚nnen. Das Medikament erreichte in Tierversuchen eine No-Observed-Adverse-Event-Level bei 1.200 mg/kg und wird als orale Gummib盲rchen formuliert, die f眉r MPox-Patienten mit oralen L盲sionen geeignet sind.
Das Unternehmen zielt auf einen mehrmilliardenschweren globalen Markt f眉r die Bioterrorismusvorsorge bei Pockenviren ab, mit besonderem Fokus auf den US Strategic National Stockpile-Markt nach erfolgreichen Phase-II-Studien.
- Successful Phase I trial showing no adverse events or serious adverse events
- High safety profile with NOAEL at 1,200 mg/kg in animal studies
- Unique host-mimetic technology designed to prevent viral escape
- Oral gummy formulation specifically designed for MPox patients
- Potential access to multi-billion-dollar bioterrorism preparedness market
- Still in early clinical development phase
- No efficacy data in humans yet
- Dependent on successful Phase II trials for market entry
- Multiple competitors already in the market despite limitations
Insights
NanoViricides' MPox drug NV-387 enters Phase II amid extended global emergency, potentially addressing critical treatment gaps.
The WHO's extension of the MPox Public Health Emergency of International Concern (PHEIC) significantly elevates the importance of NanoViricides' clinical development program. The continued spread of MPox in Africa, with sporadic travel-related cases appearing globally including in the US, creates an urgent medical need that currently lacks effective therapeutic options.
What's particularly notable is the treatment gap in the current MPox landscape. The press release correctly identifies that no safe and effective drug is currently approved for MPox treatment. The two existing options have significant limitations: tecovirimat (SIGA) failed to demonstrate effectiveness over standard care in clinical trials, while brincidofovir caused drug-induced liver disease in all three treated patients in an observational study, forcing treatment cessation.
NV-387's mechanism of action represents a potentially superior approach to existing therapies. Unlike small molecule drugs that viruses can escape through mutations, NV-387 mimics heparan sulfate proteoglycans (HSPG) - cell surface features that over 90% of human pathogenic viruses bind to regardless of mutations. This host-mimetic approach theoretically offers a higher barrier to viral resistance.
The safety profile appears promising based on Phase I data showing no adverse events and favorable animal toxicity studies, with a No-Observed-Adverse-Event Level at 1,200 mg/kg. The oral gummy formulation that dissolves in the mouth addresses a critical practical challenge for MPox patients who may have oral lesions preventing pill swallowing.
The MPox market opportunity extends beyond treatment to include bioterrorism preparedness, where the US Strategic National Stockpile has already invested approximately $1 billion for other less effective agents. A successful Phase II trial could position NanoViricides to capture significant market share in this space.
The timing of this development is particularly strategic given the ongoing spread of MPox Clade Ib in Africa and limited vaccine uptake due to logistical and financial barriers.
SHELTON, CONNECTICUT / / July 16, 2025 / NanoViricides, Inc., a publicly traded company (NYSE American:) (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, comments on the extension of the MPox Public Health Emergency of International Concern (PHEIC) by WHO.
The Director General of WHO has extended the PHEIC declaration for MPox epidemic according to a WHO news release dated July 10, 2025, following continuing upsurge of the MPox virus (MPXV) epidemics in the African region[1].
Sporadic travel related cases of MPXV Clade I have occurred outside Africa, including in the USA, but so far have not resulted in further transmission. The threat of such sustained transmission continues, and is part of the decision to continue the PHEIC status.
"Our development of NV-387 towards Phase II clinical trial for treatment of MPOX is timely for responding to the continuing threat of a global spread of MPox, and for meeting the need for treatment of MPox patients in Africa, in light of the continuing spread of MPox," said Anil R. Diwan, PhD, President and Executive Chairman of NanoViricides, Inc., adding, "If successful, this NV-387 clinical trial will also open up a multi-billion-dollar global market of preparedness for poxvirus bioterrorism to us."
At present, there is no drug approved, that is actually safe and effective in humans, for the treatment of the MPox disease, which is caused by MPXV infection. Tecovirimat (SIGA) has failed to show any effectiveness over standard of care in a clinical trial for treatment of MPXV infections. Brincidofovir treatment resulted in drug-induced liver disease in three out of three treated MPox patients resulting in cessation of therapy, and did not show any effectiveness in these patients according to a peer reviewed "retrospective observational study" also called "non-randomized study"[2], [3]. In spite of this, a clinical trial of brincidofovir for treating MPox was initiated under an international coalition led by US CDC and first patient was dosed around January 2025 in this "MOSA" clinical trial[4]. The topline results from this clinical trial regarding safety and efficacy were anticipated by CY Q2 (i.e. June, 2025). We have not found any press releases announcing any such results.
The orthopoxviruses can escape both small chemical drugs, tecovirimat and brincidofovir, by mutations, according to peer reviewed scientific articles[5].
The above factors clearly highlight the need for an effective therapeutic for the treatment of MPOX.
In contrast to the small chemical drugs, vaccines, antibodies, that viruses escape readily, NV-387, the novel broad-spectrum antiviral developed by the Company, is designed such that viruses would not escape the drug. This is because NV-387 mimics the cell-side feature called heparan sulfate proteoglycans (HSPG) to which the viruses bind and concentrate next to the cell before they can attack the cell and cause infection. No matter how much a human pathogenic virus mutates, it continues to bind to HSPG. Over
Additionally, NV-387 has been found to be extremely safe and well tolerated in a Phase I human clinical trial. There were no reported adverse events or serious adverse events in this clinical trial. In animal studies, NV-387 was found to be extremely safe, with a No-Observed-Adverse-Event Level (NOAEL) of the drug at 1,200 mg/kg, and the Maximum Tolerated Dose (MTD) at 1,500 mg/kg in intravenous injection in rats. The Phase I clinical trial results for NV-387 were consistent with the safety observations in animal model studies.
NV-387 is orally available and is formulated as oral gummies that are soft solids that do not require swallowing, and are designed to dissolve in the oral cavity itself. This is important because MPox patients may not have the ability to swallow pills or capsules because of viral lesions in the oral cavity.
The Company recently announced that it has completed the development of a clinical trial protocol for the impending Phase II study of NV-387 for the treatment of MPox disease in the African Region. This will be a randomized clinical trial comparing NV-387 treatment with the Standard of Care, to evaluate the dosing regimen for NV-387, the safety and tolerability of the dosing regimen in MPox patients, and effectiveness of NV-387 on the MPXV virus and the MPox disease that it causes.
Of note, both tecovirimat and brincidofovir were approved by the US FDA for smallpox virus, based on the "Animal Rule", which avoids the use of human efficacy clinical trials that would be unethical to conduct with a smallpox challenge study in humans.
We also note that smallpox is a more severe disease than even the most severe form of MPox disease, and both of these drugs have been found to be inadequate for the treatment of MPox according to currently available datasets (although definitive data from the brincidofovir clinical trial has not been released yet).
These two drugs (tecovirimat and brincidofovir) have been acquired in the US Strategic National Stockpile for bioterrorism preparedness to the tune of around billion dollars. The overall global market for bioterrorism preparedness against smallpox variants is estimated to be several billions of dollars.
The Company anticipates that a successful Phase II clinical trial of NV-387 for the treatment of MPox would open up the US Government SNS market and similar global markets to our drug and benefit the Company's other programs as well.
MPXV Clade Ib strain is dominant in major parts of Africa and continues to spread, whereas the less virulent MPXV Clade IIb strain is dominant in Sierra Leone, with cases increasing at present. While vaccination has started, overall, the uptake of available vaccines has remained lower than anticipated due to logistical, operational, and financial barriers, according to the report of the International Health Regulations (2005) (IHR) Emergency Committee for MPox of the WHO on June 5, 2025.
MPXV Clade II has become epidemic, within limited population demographics, in the Western world including the USA since a 2022 epidemic it caused, driven by travel-related transfer from Western Africa.
The PHEIC regarding MPox 2024 was first declared on August 14, 2024, and was extended in February 2025. It has been extended again now as the MPXV continues to spread in neighboring countries in Africa threatening further global spread and sustained transmission.
NanoViricides, Inc. (the "Company") () 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鈩� class of drug candidates and the nanoviricide鈩� 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庐 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.
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NanoViricides, Inc.
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[1]
[2] Adler H. et al., "Clinical features and management of human monkeypox: a retrospective observational study in the UK", Lancet Infect Dis 2022; 22: 1153-62, Published Online May 24, 2022, corrected May 26, https://doi.org/10.1016/ S1473-3099(22)00228-6. NHS England High Consequence Infectious Diseases (Airborne) Network.
[3] We hereby clarify that in a previous press release dated July 1, 2025, we incorrectly identified the study of the three subjects treated with brincidofovir as an initiating part of a clinical trial. The report (footnote #2) was a "retrospective review of cases" on behalf of the NHS England High Consequence Infectious Diseases (Airborne) Network, and not part of a clinical trial.
[4] .
[5] Becker et al - RW Moyer group "Isolation and characterization of cidofovir resistant vaccinia viruses", Virology Journal 2008, 5:58 doi:10.1186/1743-422X-5-58. Brincidofovir is a prodrug of cidofovir, which means cellular enzymes convert it to cidofovir.
SOURCE: NanoViricides, Inc.
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FAQ
What are the key advantages of NanoViricides' NV-387 over existing MPox treatments?
What were the safety results of NV-387 in clinical trials?
How does NNVC plan to commercialize NV-387?
What is the current development stage of NV-387 for MPox treatment?
Why is NV-387's oral gummy formulation significant for MPox treatment?
