NanoViricides Provides an Update on Its Clinical Program and Strategy - NV-387 Could be As Revolutionary as Antibiotics - Seite 2

The Company therefore plans to continue to investigate the effectiveness of NV-387 against infections by many of these viruses to broaden the scope and applicability of use of NV-387 as a broad-spectrum antiviral, just as antibiotics are used today for bacterial infections.

The Company is in the progress of completing a database audit of its current Phase 1a/1b human clinical trial of NV-387 in healthy subjects in India. We have also asked for an external technical audit of the clinical trial, which is in progress. Once the audits are completed, a data-lock will be effected and then the database will be analyzed statistically to evaluate the effect of NV-387 treatment regarding safety and tolerability of the drug at the different single and multiple dose regimens of NV-387 that were used in the clinical trial. Then a final Phase I clinical trial report will be prepared.

Simultaneously, we are preparing for a Phase II clinical trial with the objective of evaluation of effectiveness of NV-387 as an antiviral in humans. We have initiated the required non-clinical GLP animal studies already, and anticipate the reports on these studies by the end of CY 2025.

We have also started developing different clinical trial strategies for the Phase II. The unique broad-spectrum nature of NV-387 enables the possibility of designing a novel, adaptive clinical trial that could evaluate the effectiveness of NV-387 against multiple respiratory viruses under a single Phase II clinical trial. Such a novel design has not been attempted before, although screening of multiple different drugs in a single clinical trial against the same virus has been performed for Ebola as well as for COVID. Thus, such a clinical trial design could be a major advance in the field of clinical science. More importantly, such a clinical trial could quickly provide information regarding which viruses NV-387 is most effective against, to guide further regulatory clinical development of NV-387 towards approval against one or more indications while minimizing the time and costs to get there.

We have also started designing a traditional Phase II human clinical trial with the ultimate objective of regulatory approval of NV-387 for the treatment of pediatric RSV disease. We plan on a Pre-IND application with the US FDA or equivalent advice-seeking applications in other regulatory regions to guide further development of our clinical program for NV-387.