NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon - Seite 2

NV-387 Development Towards Regulatory Approval for RSV Infections in Adults, Infants and Children

In addition, we have begun clinical trial design for a Phase II trial to evaluate NV-387 effectiveness in RSV patients. We plan on submitting a pre-IND application with the US FDA given the extremely broad antiviral spectrum of NV-387 in order to obtain substantive input to further direct our clinical trial design efforts. We anticipate an initial Phase II study in adults, and if successful, a Phase II/III study in RSV-infected hospitalized infants and children with the goal of approval for commercialization.

NanoViricides Drug Pipeline Addresses Several Billion Dollars in Market Sizes for Many Unmet Medical Needs

The market size of an RSV therapeutics is estimated to be of the order of $8.73 Billions in 2031 according to a report by Growth Plus Reports (https://finance.yahoo.com/news/respiratory-syncytial-virus-rsv-therapeutics-093200835.html?guccounter=1). There are no drugs currently available for the treatment of RSV infection, except for a highly toxic drug, ribavirin, that may be given as a last resort. Two vaccines were approved in 2023 for adults, namely, Arexvy (developed by GSK plc) and Abrysvo (Pfizer). In addition, two antibodies, Nirsevimab (Beyfortus, Astrazeneca), and palivizumab (Synagis, Sobi, Inc.) are available as prophylactics for use in infants and children at risk of developing RSV infection, but are not approved for treatment. Thus NV-387 has strong prospects for treatment of RSV infection in adults as well as in infants and children, solving an unmet medical need.

Escape of Viruses from NanoViricides Platform Drugs is Unlikely

A nanoviricide is designed by mimicking the invariant host-side features, and by attaching the mimic to a chemical nanomachine that destroys the virus without requiring human immune system assistance. These specific molecular signature features on the host cellular side do not change even as the virus mutates. Thus, no matter how much a virus changes in the field, it is unlikely to escape the nanoviricide drug because the drug is designed to mimic the very features that the virus uses to bind to and enter cells. NanoViricides Platform Technology provides this important advantage. In contrast, viruses readily escape antibodies, vaccine-induced immunity, as well as small chemical antiviral drugs, as they evolve in the field, as is well known from the COVID-19 pandemic as well as Influenza pandemics and the continuing HIV/AIDS pandemic.