Adaptive Clinical Protocol Design for Phase II MPox Clade I Treatment with a Novel Broad-Spectrum Drug NV-387 is Almost Complete, Reports NanoViricides
NanoViricides (NYSE:NNVC) has nearly completed the design of an adaptive clinical trial protocol for testing NV-387, their novel broad-spectrum antiviral drug, for treating MPox Virus Clade Ia and Ib infections. The trial will involve approximately 80 patients across two phases (IIa and IIb) in the Democratic Republic of Congo.
The Phase IIa will include 20 patients (10 in treatment arm, 10 in control), while Phase IIb will involve 60 patients in a 2:1 randomization (40 treatment, 20 control). The study will use "NV-387 Oral Gummies," designed specifically for MPox patients who have difficulty swallowing due to mucosal lesions.
If successful, NV-387 would be the first effective drug for MPox treatment in human clinical trials. The company plans to pursue regulatory approvals in Africa, USA, and EU, with potential for Orphan Drug Designation in the USA. The market opportunity is significant, as demonstrated by competitor SIGA's Tecovirimat generating over $600 million in US government sales through December 2024.
NanoViricides (NYSE:NNVC) ha quasi completato la progettazione di un protocollo di studio clinico adattativo per testare NV-387, il loro nuovo farmaco antivirale ad ampio spettro, per il trattamento delle infezioni da virus MPox Clade Ia e Ib. Lo studio coinvolgerà circa 80 pazienti in due fasi (IIa e IIb) nella Repubblica Democratica del Congo.
La fase IIa includerà 20 pazienti (10 nel gruppo di trattamento, 10 nel gruppo di controllo), mentre la fase IIb coinvolgerà 60 pazienti con una randomizzazione 2:1 (40 trattamento, 20 controllo). Lo studio utilizzerà le "NV-387 Oral Gummies", appositamente progettate per i pazienti MPox che hanno difficoltà a deglutire a causa di lesioni mucosali.
Se avrà successo, NV-387 sarà il primo farmaco efficace per il trattamento del MPox in studi clinici sull'uomo. L'azienda intende richiedere approvazioni regolatorie in Africa, USA e UE, con la possibilità di ottenere la Designazione di Farmaco Orfano negli USA. L'opportunità di mercato è significativa, come dimostrato dal concorrente SIGA con il Tecovirimat, che ha generato oltre 600 milioni di dollari in vendite al governo USA fino a dicembre 2024.
NanoViricides (NYSE:NNVC) ha casi completado el diseño de un protocolo de ensayo clínico adaptativo para probar NV-387, su novedoso medicamento antiviral de amplio espectro, para tratar infecciones por el virus MPox Clado Ia y Ib. El ensayo involucrará aproximadamente a 80 pacientes en dos fases (IIa y IIb) en la República Democrática del Congo.
La fase IIa incluirá a 20 pacientes (10 en el grupo de tratamiento, 10 en el grupo control), mientras que la fase IIb involucrará a 60 pacientes con una aleatorización de 2:1 (40 tratamiento, 20 control). El estudio utilizará "NV-387 Gummies Orales", diseñadas específicamente para pacientes con MPox que tienen dificultad para tragar debido a lesiones mucosas.
Si tiene éxito, NV-387 sería el primer medicamento efectivo para el tratamiento de MPox en ensayos clínicos humanos. La empresa planea buscar aprobaciones regulatorias en África, EE.UU. y la UE, con potencial para la Designación de Medicamento Huérfano en EE.UU. La oportunidad de mercado es significativa, como lo demuestra el competidor SIGA con Tecovirimat, que generó más de 600 millones de dólares en ventas al gobierno de EE.UU. hasta diciembre de 2024.
NanoViricides (NYSE:NNVC)는 MPox 바이러스 클레이드 Ia 및 Ib 감염 치료를 위한 새로운 광범위 항바이러스제 NV-387의 적응형 임상시험 프로토콜 설계를 거의 완료했습니다. 이 임상시험은 콩고 민주 공화국에서 두 단계(IIa 및 IIb)에 걸쳐 약 80명의 환자를 대상으로 진행됩니다.
2단계 IIa에는 20명의 환자(치료군 10명, 대조군 10명)가 포함되며, 2단계 IIb에는 2:1 무작위 배정으로 60명의 환자(치료군 40명, 대조군 20명)가 참여합니다. 연구에는 점막 병변으로 인해 삼키기 어려운 MPox 환자들을 위해 특별히 설계된 "NV-387 구강 젤리"가 사용됩니다.
성공할 경우 NV-387은 인간 임상시험에서 MPox 치료를 위한 최초의 효과적인 약물이 될 것입니다. 회사는 아프리카, 미국, EU에서 규제 승인을 추진할 계획이며, 미국에서 희귀 의약품 지정 가능성도 있습니다. 시장 기회는 SIGA의 Tecovirimat가 2024년 12월까지 미국 정부에 6억 달러 이상의 매출을 올린 것으로 입증된 바와 같이 상당합니다.
NanoViricides (NYSE:NNVC) a presque finalisé la conception d'un protocole d'essai clinique adaptatif pour tester NV-387, leur nouveau médicament antiviral à large spectre, pour le traitement des infections par le virus MPox Clade Ia et Ib. L'essai impliquera environ 80 patients répartis en deux phases (IIa et IIb) en République démocratique du Congo.
La phase IIa comprendra 20 patients (10 dans le groupe traitement, 10 dans le groupe contrôle), tandis que la phase IIb impliquera 60 patients avec une randomisation 2:1 (40 traitement, 20 contrôle). L'étude utilisera des "gommes orales NV-387", spécialement conçues pour les patients MPox ayant des difficultés à avaler en raison de lésions muqueuses.
En cas de succès, NV-387 serait le premier médicament efficace pour le traitement du MPox lors d'essais cliniques humains. La société prévoit de demander les autorisations réglementaires en Afrique, aux États-Unis et dans l'UE, avec un potentiel pour la désignation de médicament orphelin aux États-Unis. L'opportunité de marché est importante, comme le démontre le concurrent SIGA avec Tecovirimat, qui a généré plus de 600 millions de dollars de ventes au gouvernement américain jusqu'en décembre 2024.
NanoViricides (NYSE:NNVC) hat die Entwicklung eines adaptiven klinischen Prüfprotokolls zur Erprobung von NV-387, ihrem neuartigen Breitband-Antiviralum, zur Behandlung von MPox-Virus Clade Ia und Ib Infektionen nahezu abgeschlossen. Die Studie wird etwa 80 Patienten in zwei Phasen (IIa und IIb) in der Demokratischen Republik Kongo umfassen.
Die Phase IIa umfasst 20 Patienten (10 in der Behandlungsgruppe, 10 in der Kontrollgruppe), während Phase IIb 60 Patienten mit einer 2:1-Randomisierung (40 Behandlung, 20 Kontrolle) einschließt. Die Studie verwendet "NV-387 orale Gummibärchen", speziell für MPox-Patienten entwickelt, die aufgrund von Schleimhautläsionen Schwierigkeiten beim Schlucken haben.
Bei Erfolg wäre NV-387 das erste wirksame Medikament für die MPox-Behandlung in klinischen Studien am Menschen. Das Unternehmen plant, Zulassungen in Afrika, den USA und der EU anzustreben, mit Potenzial für die Orphan-Drug-Zulassung in den USA. Die Marktchance ist beträchtlich, wie der Wettbewerber SIGA mit Tecovirimat zeigt, der bis Dezember 2024 über 600 Millionen US-Dollar an US-Regierungsverkäufen erzielt hat.
- First potential effective drug for MPox treatment in human clinical trials
- Novel Oral Gummies formulation specifically designed for MPox patients
- Significant market opportunity demonstrated by competitor's $600M+ government sales
- Potential for Orphan Drug Designation in the USA
- Comprehensive two-phase adaptive trial design with 80 patients
- No current FDA approval yet
- Complex multi-phase trial process ahead
- Strong competition from existing approved drugs despite their limitations
- Clinical trials conducted primarily in Africa may require additional studies for US/EU approval
Insights
NanoViricides' adaptive Phase II MPox trial design completion signals advancement of NV-387 toward potential first effective treatment option.
The completion of NanoViricides' adaptive clinical protocol design represents a significant development milestone for their novel drug NV-387. The two-part trial structure is particularly well-conceived: Phase IIa will evaluate initial dosing in 20 patients (10 treatment, 10 control) at a single DRC site, while Phase IIb will expand to a 2:1 randomization with approximately 60 patients potentially across multiple African sites experiencing severe MPox outbreaks.
The adaptive design is clinically sophisticated and offers several advantages over traditional fixed protocols. It allows for real-time adjustments to dosing regimens based on emerging safety and efficacy data, potentially shortening development timelines while providing comprehensive data on three critical aspects: dosing regimen, safety/tolerability, and antiviral effectiveness.
The development of an oral gummies formulation demonstrates thoughtful consideration of patient needs, as MPox causes painful oral lesions that can make traditional pill swallowing difficult. This patient-centric approach may improve compliance and outcomes.
The competitive landscape appears favorable, with current alternatives showing significant limitations. Tecovirimat reportedly failed clinical trials for MPox treatment, showing no improvement over standard of care. Brincidofovir faced severe safety concerns with drug-induced liver injury in early patients. The absence of follow-up data from the MOSA trial (mentioned as having possible Q1/Q2 2025 readouts) suggests potential issues with that program as well.
If successful, NV-387 would represent the first clinically effective orthopoxvirus treatment in humans - a significant medical breakthrough for an indication with limited treatment options, particularly for the more severe Clade 1 variants with case fatality rates of 1-11%.
This protocol completion places NanoViricides in position to potentially capture significant market share in the orthopoxvirus treatment space. The press release strategically highlights a dual-market opportunity: MPox treatment (an orphan indication in the US) and smallpox bioterrorism preparedness.
The competitive benchmark provided is particularly revealing - they cite competitor SIGA's
The regulatory strategy shows market savvy, pursuing African approvals first where the medical need is greatest and regulatory pathways may be expedited, while simultaneously developing for US/EU markets. This multi-region approach maximizes both humanitarian impact and commercial potential.
The development focuses on Clade 1 variants (particularly 1b) currently prevalent in Africa. This is strategically sound as these cause more severe disease with higher fatality rates than the Clade 2b variants common in Western countries. Successfully treating the more virulent strains would position NV-387 as the premier therapeutic option globally.
The product formulation as oral gummies addresses a specific clinical challenge of the disease while potentially offering commercial advantages in terms of patient preference and compliance. This differentiation from traditional oral medications may support premium pricing.
Worth noting is the broader platform potential - while this trial focuses on MPox, the press release indicates NV-387 is being developed as a broad-spectrum antiviral for respiratory infections including RSV, COVID, Long COVID, and influenza. This suggests significant pipeline expansion opportunities beyond the immediate MPox indication.
SHELTON, CT / ACCESS Newswire / July 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, announces that the design of the adaptive clinical trial protocol for the treatment of MPox Virus Clade Ia and Ib infections and disease is nearly complete.
The adaptive clinical trial is designed to provide information on three important aspects in a single, compact clinical trial:
safe and effective dosing regimen in patients,
safety and tolerability of the drug in patients, and
antiviral effectiveness of the drug in patients.
The overall clinical trial will enroll approximately 80 patients.
"This is an important milestone towards filing of the clinical trial application and starting the clinical trial," said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, "Our CRO and the Principal Investigator have created a marvelous design that is both frugal and efficient while providing all of the information necessary for understanding the safety and effectiveness of NV-387 for treating MPox disease."
Currently there is no drug approved for the treatment of MPox disease that is actually effective for treating the disease.
NV-387, if it shows effectiveness, will be the very first drug that has shown effectiveness in human clinical trial of an orthopoxvirus.
If NV-387 is found to be effective in this Phase II clinical trial, the Company intends to continue further development of NV-387 for treatment of orthopoxvirus infections under a US FDA IND towards studies as needed for regulatory approval of NV-387 for the treatment of MPox as well as Smallpox indications. The Company intends to obtain regulatory approval in the African Region as well, which is likely to arrive before a US approval, and also seek approvals in the European Union and other countries and regions.
MPox is an Orphan disease in the USA and treatment of MPox by NV-387 is eligible for Orphan Drug Designation by the US FDA with attendant benefits.
Smallpox is a bioterrorism agent of concern in the USA as well as across the world and is an important revenue opportunity for the Company. Tecovirimat sales to the US Government alone have netted SIGA, the drug holder, over
The adaptive, randomized, SOC controlled clinical trial will proceed in two parts:
In Phase IIa part, an oral dose of the drug NV-387 given twice daily initially for six days will be compared with the standard of care (SOC) at the hospital for treatment of MPox disease. Patients will be sequestered in the hospital and will be evaluated daily for clinical drug safety and tolerability parameters, and clinical MPox disease evaluation parameters. Additionally, lab evaluations including clinical blood chemistry, CBC, cytokines, urinalysis, ECG, X-rays when necessary, and virological assays will be conducted every 3 days. Based on the results, the Principal Investigator will determine whether additional days of drug dosing can be well tolerated and can improve on effectiveness. If so, the patients will continue to receive same dosing for six more days with same evaluations. The patients will be followed until full resolution of the MPox disease.
There will be two arms in this Phase IIa: The New Treatment Arm of 10 patients with NV-387 dosing plus SOC and the control SOC Arm of 10 patients. The dosing regimen for Phase IIb will be determined on the basis of Phase IIa results.
In the Phase IIb part, the clinical trial will be in a 2:1 randomized patients base with approximately 40 subjects in the New Treatment Arm and 20 patients in the SOC Arm. Evaluations will be similar to those in Phase IIa, with more emphasis given to specific points that may have come up in Phase IIa regarding safety, tolerability, as well as efficacy.
The Phase IIa will be conducted at a single site in Democratic Republic of Congo (DRC). Phase IIb may be expanded to include additional sites within DRC as well as other countries experiencing severe MPox outbreak in the African Region.
The "NV-387 Oral Gummies" drug product formulation will be employed in the Phase II. This 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.
Two drugs, Tecovirimat and Brincidofovir were approved by the US FDA for Smallpox and MPox on the basis of the US FDA "Animal Rule," i.e. based on animal infection and treatment studies only to demonstrate efficacy, and a safety/tolerability human clinical trial.
Tecovirimat failed in clinical trials for the treatment of MPox with no improvement over the standard of care. Brincidofovir was abandoned in a clinical trial of MPox due to first three patients coming down with drug induced liver injury. Despite this, brincidofovir was recently resurrected under an international coalition led by US CDC and first patient was dosed around January 2025 in the "MOSA" clinical trial [2] . The topline results were expected to be announced as early as CY Q1 (March 2025) and efficacy topline data were expected no later than CY Q2 (June, 2025). No press releases post initiation of the MOSA clinical trial could be found.
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
Clearly, the threat of MPox Clade 1 causing a potential epidemic in the USA cannot be ignored, and readiness with a drug that works against the same is important to achieve.
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
[1] https://www.sec.gov/ix?doc=/Archives/edgar/data/0001010086/000143774925007056/siga20241231_10k.htm
View the original press release on ACCESS Newswire
FAQ
What is the design of NanoViricides' (NNVC) Phase II MPox clinical trial?
How does NV-387 differ from existing MPox treatments?
What is the market potential for NNVC's MPox treatment?
What is unique about NNVC's NV-387 drug formulation for MPox?
What regulatory pathways is NNVC pursuing for NV-387?
What is the difference between MPox Clade 1 and Clade 2?
