NanoViricides Continues Its March Towards a Phase II Clinical Trial of NV-387 - A Potentially Revolutionary First Line Antiviral Therapy for RSV, COVID, and Other Viral Infections
NanoViricides is progressing towards a Phase II clinical trial of its drug candidate NV-387, aimed at treating multiple viral infections including RSV, COVID, and Influenza. Dr. Anil Diwan is collaborating with experts to develop a trial plan and protocol. NV-387 has demonstrated strong effectiveness in animal studies and could potentially become a first-line treatment for respiratory viral infections, eliminating the need for testing virus types before treatment.
The estimated market size for these infections is over $8 billion in 2024, expected to grow to $12 billion by 2027. The Phase II trial will assess NV-387's effectiveness against multiple viruses in a single study, aiming to reduce costs and enhance return on investment. NV-387 recently completed a Phase I trial, showing good tolerability. The company envisions a new paradigm in treating viral infections, similar to broad-spectrum antibiotics for bacteria.
NanoViricides sta avanzando verso una sperimentazione clinica di Fase II del suo candidato farmaco NV-387, mirato al trattamento di molteplici infezioni virali, tra cui RSV, COVID e Influenza. Il Dr. Anil Diwan sta collaborando con esperti per sviluppare un piano e un protocollo per la sperimentazione. NV-387 ha dimostrato una forte efficacia negli studi sugli animali e potrebbe diventare un trattamento di prima linea per le infezioni virali respiratorie, eliminando la necessità di testare i tipi di virus prima del trattamento.
Si stima che il mercato per queste infezioni supererà gli 8 miliardi di dollari nel 2024, con una previsione di crescita a 12 miliardi di dollari entro il 2027. La sperimentazione di Fase II valuterà l’efficacia di NV-387 contro molteplici virus in un unico studio, con l’obiettivo di ridurre i costi e aumentare il ritorno sugli investimenti. NV-387 ha recentemente completato una sperimentazione di Fase I, mostrando una buona tollerabilità. L’azienda immagina un nuovo paradigma nel trattamento delle infezioni virali, simile agli antibiotici ad ampio spettro per i batteri.
NanoViricides está avanzando hacia un ensayo clínico de Fase II de su candidato a medicamento NV-387, destinado al tratamiento de múltiples infecciones virales, incluida la RSV, COVID e Influenza. El Dr. Anil Diwan está colaborando con expertos para desarrollar un plan y protocolo de ensayo. NV-387 ha demostrado una fuerte efectividad en estudios en animales y podría convertirse en un tratamiento de primera línea para las infecciones virales respiratorias, eliminando la necesidad de testar los tipos de virus antes del tratamiento.
Se estima que el tamaño del mercado para estas infecciones superará los 8 mil millones de dólares en 2024, y se prevé que crecerá a 12 mil millones de dólares para 2027. El ensayo de Fase II evaluará la efectividad de NV-387 contra múltiples virus en un solo estudio, con el objetivo de reducir costos y aumentar el retorno de inversión. NV-387 completó recientemente un ensayo de Fase I, mostrando buena tolerabilidad. La compañía visualiza un nuevo paradigma en el tratamiento de infecciones virales, similar a los antibióticos de amplio espectro para bacterias.
NanoViricides는 RSV, COVID 및 독감을 포함한 여러 바이러스 감염을 치료하기 위한 약물 후보인 NV-387의 임상 2상 시험을 진행하고 있습니다. Anil Diwan 박사는 시험 계획과 프로토콜을 개발하기 위해 전문가들과 협력하고 있습니다. NV-387은 동물 연구에서 강력한 효능을 입증하였으며, 치료 전에 바이러스 유형을 테스트할 필요 없이 호흡기 바이러스 감염에 대한 1차 치료제가 될 가능성이 있습니다.
이러한 감염에 대한 예상 시장 규모는 2024년까지 80억 달러를 초과하고, 2027년에는 120억 달러에 이를 것으로 예상됩니다. 2상 시험에서는 NV-387의 여러 바이러스에 대한 효과를 단일 연구에서 평가하여 비용을 절감하고 투자 수익을 높이는 것을 목표로 합니다. NV-387은 최근 1상 시험을 완료하였으며, 좋은 내약성을 보여주었습니다. 이 회사는 세균에 대한 광범위 항생제와 유사한 바이러스 감염 치료의 새로운 패러다임을 구상하고 있습니다.
NanoViricides progresse vers un essai clinique de Phase II pour son candidat médicament NV-387, visant à traiter plusieurs infections virales, y compris le RSV, COVID et la grippe. Le Dr Anil Diwan collabore avec des experts pour développer un plan d'essai et un protocole. NV-387 a démontré une forte efficacité dans des études animales et pourrait potentiellement devenir un traitement de première ligne pour les infections virales respiratoires, éliminant ainsi la nécessité de tester les types de virus avant le traitement.
La taille estimée du marché pour ces infections dépasse 8 milliards de dollars en 2024, avec une prévision de croissance à 12 milliards de dollars d'ici 2027. L'essai de Phase II évaluera l'efficacité de NV-387 contre plusieurs virus dans une seule étude, visant à réduire les coûts et à améliorer le retour sur investissement. NV-387 a récemment terminé un essai de Phase I, montrant une bonne tolérance. L'entreprise envisage un nouveau paradigme dans le traitement des infections virales, similaire aux antibiotiques à large spectre pour les bactéries.
NanoViricides schreitet auf eine klinische Studie der Phase II mit seinem Arzneimittelkandidaten NV-387 zu, der auf die Behandlung mehrerer Virusinfektionen abzielt, einschließlich RSV, COVID und Influenza. Dr. Anil Diwan arbeitet mit Experten zusammen, um einen Prüfungsplan und ein Protokoll zu entwickeln. NV-387 hat in Tierversuchen eine starke Wirksamkeit gezeigt und könnte potenziell eine Erstbehandlung für respiratorische Virusinfektionen werden, was die Notwendigkeit einer Testung der Virustypen vor der Behandlung überflüssig macht.
Die geschätzte Marktgröße für diese Infektionen liegt im Jahr 2024 bei über 8 Milliarden Dollar und soll bis 2027 auf 12 Milliarden Dollar wachsen. Die Phase-II-Studie wird die Wirksamkeit von NV-387 gegen mehrere Viren in einer einzigen Studie bewerten, mit dem Ziel, die Kosten zu senken und den Kapitalertrag zu erhöhen. NV-387 hat kürzlich eine Phase-I-Studie abgeschlossen, bei der eine gute Verträglichkeit festgestellt wurde. Das Unternehmen stellt sich ein neues Paradigma für die Behandlung von Virusinfektionen vor, ähnlich wie Breitbandantibiotika für Bakterien.
- Progress towards Phase II clinical trial for NV-387.
- Potential market size of over $8 billion for NV-387 in 2024, growing to $12 billion by 2027.
- Successful Phase I trial showing good tolerability of NV-387.
- Innovative Phase II trial design could reduce development costs and improve ROI.
- Regulatory approval required for the novel Phase II trial design.
Insights
NanoViricides' progress towards a Phase II trial for NV-387 is a significant development in the antiviral space. The drug's potential as a broad-spectrum antiviral for RSV, COVID and influenza addresses a substantial market, estimated at
The innovative trial design, aiming to test NV-387 against multiple viruses simultaneously, could revolutionize antiviral treatment approaches. If successful, it could enable immediate treatment without prior virus identification, similar to broad-spectrum antibiotics. This could significantly improve treatment outcomes and change clinical practices.
However, investors should note that while the concept is promising, regulatory approval for this novel trial design is still pending. The success of NV-387 in animal studies is encouraging, but human trials may yield different results. The lack of viral escape potential is a compelling feature, but needs clinical validation.
NanoViricides' focus on a single drug candidate (NV-387) targeting multiple high-value indications presents an intriguing investment proposition. The potential
The company's strategy to conduct a single Phase II trial for multiple indications could substantially reduce development costs and time-to-market, potentially improving ROI. However, this approach also concentrates risk – any setback with NV-387 could significantly impact the company's prospects.
Investors should consider that NanoViricides is still in clinical stages, with no approved products or revenue. The company's financial health and ability to fund continued development through potential commercialization will be important factors to monitor. The broad-spectrum potential of NV-387 could attract partnership or acquisition interest from larger pharmaceutical companies, potentially providing additional value for shareholders.
NanoViricides' NV-387 represents a novel approach in antiviral therapy, leveraging nanoviricide technology to target a common feature used by multiple viruses. This broad-spectrum potential differentiates it from traditional antivirals that often target specific viral components.
The company's claim of potential effectiveness against evolving viruses due to its host-side targeting mechanism is particularly noteworthy. If proven, this could address a significant challenge in antiviral development – the rapid mutation and escape of viruses from current therapies.
However, the complexity of the nanoviricide platform and its novelty may present regulatory hurdles. The FDA's approach to evaluating such a broad-spectrum antiviral in a single trial will be crucial. Additionally, manufacturing scalability and cost-effectiveness of nanoviricide-based drugs will be important factors for commercial viability.
While promising, investors should be aware that NanoViricides is competing in a field with established players and multiple alternative approaches in development. The company's ability to navigate clinical development, regulatory processes and eventual commercialization will be critical to its success.
SHELTON, CT / ACCESSWIRE / August 19, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage global leader in broad-spectrum antiviral nanomedicines, is providing an update on its clinical program activities.
Dr. Anil Diwan, the Company's President, and Executive Chairman, is currently visiting with various expert professionals with the objective of developing a Phase II clinical trial plan and corresponding clinical protocol for a Phase II clinical trial of the drug candidate NV-387. The Company believes NV-387 is poised to become a revolutionary broad-spectrum antiviral treatment for infections from a number of viruses including RSV, COVID, and Influenzas, based on several animal studies.
Just three of the viruses addressed by this single drug NV-387, namely, Influenza, RSV and COVID, account for over
A successful Phase II clinical trial is expected to provide results demonstrating a strong effectiveness of NV-387 against different human pathogenic viruses, consistent with the strong effectiveness parameters found for NV-387 treatment of lethal virus challenge in various non-clinical animal model studies for RSV, COVID, Influenza, as well as Smallpox/Mpox.
With advice and opinions of experts, the Company is exploring the design of an innovative and ambitious, adaptive Phase II clinical trial wherein the effectiveness of the single drug NV-387 can be assessed for the treatment of a number of naturally occurring virus infections in humans in a single clinical trial.
In particular, the Company plans on exploring the effectiveness of NV-387 for the treatment of Severe Acute Respiratory Infections caused by Viruses ("SARI-Viral"). Most of such infections are caused by Influenza, RSV, and Coronaviruses, with a small extent of such infections being caused by other viruses including Adenoviruses, hMPV, and others.
If successful in such a clinical trial, NV-387 could become the very first drug that could be indicated as a first line treatment of any respiratory viral infections without having to wait for the results of testing for the type of virus, in a manner similar to how antibiotics can be prescribed by physicians at present.
"We are already preparing for a novel Phase II clinical trial design to evaluate the effectiveness of NV-387 against RSV, Influenza, and COVID in a single clinical trial," said Dr. Diwan, adding, "Such a clinical trial design would save substantially on the costs of development, improve return on investment, as well as open new avenues of how to treat a respiratory viral infection for physicians, thereby defining a new chapter in humanity's fight against viruses and pandemics."
It is well known that early treatment of a viral infection improves chances of success, but the need for testing for the type of infecting virus in order to select appropriate treatment necessarily introduces a delay in the treatment. Development of NV-387 as a broad-spectrum antiviral that addresses most respiratory viral infections is expected to eliminate this need for testing and thus the corresponding delay thereby enabling immediate treatment and improving success rates. This novel paradigm for treating viral infections enabled by the broad-spectrum nature of NV-387 would be similar to the current practice for most bacterial infections that can be immediately treated with a broad-spectrum antibiotic.
NV-387 has recently completed a Phase I clinical trial for the evaluation of safety and tolerability in healthy volunteers. The data analysis from this clinical trial is expected to begin soon. We have previously reported on the basis of clinical observations that NV-387 was found to be well tolerated in this clinical trial at all dosage levels.
The Company notes that the idea of such a Phase II trial design originated from physicians actively treating patients, and that this idea has been received enthusiastically by several experts in both medical and regulatory domains. The Company further notes that any such novel Phase II clinical trial design as we are envisaging would require regulatory approval from appropriate regulatory authorities prior to executing it.
NV-387 is designed to mimic a host-side feature that over
A virus would not be able to escape the nanoviricide drug NV-387 even as the virus evolves, we believe, because, despite the multiple changes in it, the virus continues to use the same host-side feature for successful infection. This potential lack of viral escape expected for NV-387 is unlike most, if not all, current antiviral medical countermeasures (MCMs), including vaccines, antibodies, and small chemical drugs. Viruses readily escape the current MCMs as the viruses evolve in the field, which has now become general knowledge with the experience from recent pandemics.
The Company has already found that NV-387 was superior to or equivalent to existing drugs in non-clinical animal trials in the case of three major classes of viruses: RSV, Influenza, and COVID; the so-called "triple-demic" respiratory viruses - and even orthopoxviruses (Smallpox/Mpox). These animal studies have laid the foundation for the innovative Phase II clinical trial design that came about in discussions with physicians.
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-387 for the treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections. Our other advanced 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 poxviruses and/or enteroviruses if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas 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.
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".
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
ir@nanoviricides.com
SOURCE: NanoViricides, Inc.
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