NanoViricides | MedPath

NanoViricides' Broad-Spectrum Antiviral NV-387 Advances to Phase II Trials for MPox Treatment

15 days ago

• NanoViricides has received approval from the Democratic Republic of Congo's National Ethics Committee to proceed with Phase II clinical trials of NV-387 for MPox treatment, addressing a significant unmet need as no effective treatment currently exists. • NV-387 employs a revolutionary host-mimetic mechanism that "looks like a cell" to viruses, potentially making it effective against 90-95% of human pathogenic viruses while being highly resistant to viral escape mutations. • The drug has demonstrated superior efficacy in animal models against multiple viruses including influenza, RSV, coronavirus, and orthopoxviruses, outperforming existing treatments like Tamiflu, remdesivir, and matching tecovirimat against MPox-like infections.

NanoViricides Advances NV-387 as Potential Treatment for Measles Amid Declining Vaccination Rates

24 days ago

• NanoViricides is developing NV-387, a broad-spectrum antiviral drug candidate, as a potential treatment for measles in response to declining vaccination rates and increasing case numbers across the USA. • The drug candidate has successfully completed Phase I clinical trials with no adverse events reported and has demonstrated efficacy against multiple viruses that utilize the HSPG infection pathway. • NanoViricides is preparing to conduct animal model studies using humanized mice before advancing NV-387 to Phase II human clinical trials, positioning it as a critical treatment option for current and future measles outbreaks.

FDA Requests Additional Trial for Novavax COVID-19 Vaccine Before Full Approval

a month ago

• The FDA has asked Novavax to conduct an additional randomized, controlled study of its COVID-19 vaccine NVX-CoV2601 before considering full approval, despite the vaccine having emergency use authorization since 2022. • Interim results from a phase 2/3 study showed Novavax's updated XBB.1.5 variant vaccine generated 5.8 times higher neutralizing antibody levels compared to the original formulation, with a favorable safety profile. • The FDA's request represents a significant setback for Novavax, which had expected approval based on prior conversations with regulators and had already passed its April 1 PDUFA date.

NanoViricides' NV-387 Shows Promise Against Multiple Viral Threats Following Successful Phase I Trial

3 months ago

• NanoViricides has completed Phase I clinical trials for NV-387 with no reported adverse events, demonstrating potential as a broad-spectrum antiviral against MPox, RSV, influenza, and COVID-19. • The company's novel drug candidate NV-387 showed superior efficacy compared to existing treatments for influenza and demonstrated promising results against lethal RSV infections in preclinical studies. • NanoViricides is preparing to advance NV-387 into Phase II trials for multiple indications, including MPox infections and Viral Acute Respiratory Infections, while positioning the drug as a potential countermeasure against emerging H5N1 bird flu threats.

Medicus Pharma Initiates Phase 2 Study with Fast-Track Potential

3 months ago

• Medicus Pharma has launched a significant Phase 2 clinical trial, marking a crucial milestone in their drug development program. • The company is actively pursuing FDA fast-track designation, which could potentially accelerate the drug's path to market approval. • This development represents a strategic advancement in Medicus Pharma's pipeline, positioning them for expedited regulatory review.

FDA Approves Teal Health's At-Home HPV Test, Expanding Cervical Cancer Screening Access

5 months ago

• The FDA has granted approval to Teal Health's innovative "Teal Wand," the first at-home HPV test designed to improve cervical cancer screening accessibility for women. • The self-administered test allows women to collect samples in the privacy of their homes, potentially increasing screening rates among underserved populations and those who avoid traditional gynecological exams. • Teal Health's technology represents a significant advancement in preventive healthcare, addressing barriers to cervical cancer screening while maintaining clinical accuracy comparable to in-office testing.

NanoViricides' NV-387 Shows Promise Against H5N1 Bird Flu in Preclinical Studies

5 months ago

• NanoViricides' NV-387 demonstrated an 88% increase in survival rate in animal studies, surpassing existing treatments for influenza, offering a potential solution against H5N1. • The broad-spectrum antiviral drug candidate mimics essential host-side features, making it difficult for the virus to develop resistance, according to NanoViricides. • Having completed Phase I clinical trials with no adverse events, NV-387 is advancing to Phase II trials for MPox treatment and respiratory virus infections. • NV-387's mechanism targets sulfated proteoglycans, potentially preventing severe pneumonia, and its broad-spectrum activity extends to COVID, RSV, and Orthopoxviruses.

NanoViricides Advances NV-387 to Phase II Trials Targeting MPox and Respiratory Infections

6 months ago

• NanoViricides is set to advance its broad-spectrum antiviral candidate, NV-387, into Phase II clinical trials, focusing on MPox treatment in Central Africa. • NV-387 demonstrated no adverse effects in Phase Ia/Ib trials, paving the way for further clinical development in viral acute respiratory infections and pediatric RSV. • The company is also preparing NV-387 as a countermeasure against the emerging H5N1 bird flu threat, addressing limitations in current vaccines. • NanoViricides has engaged a Clinical Research Organization (CRO) to oversee the Phase II trial for MPox, with trial sites identified in two African countries.

NanoViricides' NV-387 Advances to Phase II Trials for Multiple Viral Infections

6 months ago

• NanoViricides' broad-spectrum antiviral NV-387 is set to advance to Phase II clinical trials, targeting MPOX, RSV, influenza, and COVID-19 infections. • A Phase Ia/Ib trial of NV-387 was completed with no adverse events reported, showing promising results and paving the way for further clinical development. • NV-387 has demonstrated superior effectiveness in animal trials compared to existing treatments for various viral infections, offering a potential breakthrough. • The company faces funding challenges for Phase II trials despite recent capital raises, highlighting the need for additional financial resources.

NanoViricides' NV-387 Advances to Phase II Clinical Trials for MPox Treatment

6 months ago

• NanoViricides has engaged a CRO to initiate a Phase II clinical trial for NV-387, a broad-spectrum antiviral drug. • The trial will assess NV-387's effectiveness in treating MPox patients amidst a regional pandemic in Africa. • NV-387 has demonstrated strong antiviral activity against orthopoxviruses in animal models, showing potential against MPox and Smallpox. • The drug's unique mechanism mimics cell entry pathways, potentially preventing virus escape and offering a revolutionary approach.

NanoViricides Highlights NV-387's Potential in Broad-Spectrum Antiviral Market

7 months ago

• NanoViricides is focusing on advancing NV-387, a broad-spectrum antiviral drug, into Phase 2 human clinical trials. • NV-387 has demonstrated substantial superiority to existing drugs against multiple viral diseases in animal models. • The company estimates a potential market size exceeding $10 billion by 2027 for indications treatable by NV-387. • Anil R. Diwan, Ph.D., presented a corporate update on NV-387 at the Spartan Capital Investors Conference.

NanoViricides Advances NV-387 for Herpes Zoster Treatment to Phase II Trials

8 months ago

• NanoViricides is set to begin Phase II trials for NV-387, an antiviral drug aimed at treating herpes zoster, commonly known as shingles. • NV-387 utilizes the company's proprietary nanoviricide platform to directly target and neutralize the varicella-zoster virus (VZV). • The Phase II trial will assess the drug's efficacy in reducing the duration and severity of shingles outbreaks, addressing a significant unmet medical need. • This advancement marks a crucial step in developing a novel therapeutic approach to combat VZV infections and improve patient outcomes.

NanoViricides' NV-387 Advances to Phase II Trials for RSV and MPOX Amid Funding Concerns

8 months ago

• NanoViricides' broad-spectrum antiviral NV-387 is set to advance to Phase II clinical trials for RSV and MPOX following promising preclinical results. • A Phase Ia/Ib trial of NV-387 showed no adverse events, with the drug demonstrating superior activity against RSV, influenza, and poxviruses in animal models. • The company faces financial uncertainty, expressing doubts about sustaining operations through September 2025 without additional funding despite recent capital raises. • NV-387's unique mechanism, mimicking sulfated proteoglycans, aims to address viral escape, potentially revolutionizing viral infection treatment.

NanoViricides' NV-387 Shows Promise as Broad-Spectrum Antiviral in Clinical Program Update

9 months ago

• NanoViricides is advancing NV-387, a direct-acting antiviral drug mimicking host cells, designed to disable a broad spectrum of viruses, akin to how penicillin revolutionized antibiotic treatment. • Preclinical trials indicate NV-387's superiority or equivalence to existing drugs against Influenza, COVID-19, RSV, and orthopoxviruses, demonstrating complete survival in lethally infected mice in RSV studies. • The company is progressing with Phase 1 clinical trial data analysis and preparing for a Phase 2 trial, exploring an adaptive design to evaluate NV-387's effectiveness against multiple respiratory viruses simultaneously. • NanoViricides is also strategizing for a traditional Phase 2 trial targeting pediatric RSV, seeking FDA guidance, and pursuing collaborations to expedite development and commercialization of NV-387.

NanoViricides Develops First-In-Class Broad-Spectrum Antiviral Agent NV-387

a year ago

NanoViricides, Inc. has developed NV-387, a first-in-class, broad-spectrum antiviral agent using host-mimetic technology, showing promise in treating a wide range of viral infections including RSV, COVID-19, and influenza. The drug has successfully completed Phase I human clinical trials with no adverse events reported.

NanoViricides' NV-387 Shows Broad-Spectrum Antiviral Activity Against 'Tripledemic' Viruses and Smallpox in Animal Models

a year ago

• NanoViricides' NV-387 demonstrates strong antiviral activity against coronaviruses, RSV, and influenza A viruses, including H5N1 in animal studies. • NV-387 outperformed approved anti-influenza drugs like Oseltamivir in a lethal influenza A/H3N2 lung infection model, showing superior antiviral effects. • The antiviral agent also proved effective against orthopoxviruses, including Smallpox and Mpox, increasing lifespan in a lethal animal model comparable to tecovirimat. • Phase 1 clinical trials of NV-387 in healthy subjects showed no adverse events, paving the way for Phase 2 trials focusing on RSV infections.