NanoViricides advances toward fully funded Phase II MPox trial in DRC

NanoViricides CEO Dr Anil Diwan joined Steve Darling from Proactive to announce the filing of the company’s financial results for the quarter ended December 31, along with a corporate update highlighting progress on its lead antiviral candidate, NV-387. Dr. Diwan said the company is advancing NV-387—a novel broad-spectrum antiviral that represents a new class of antiviral drugs—toward a Phase II clinical trial. NanoViricides is preparing to initiate a Phase II human study to evaluate the safety and effectiveness of NV-387 as a treatment for MPox in the Democratic Republic of Congo (DRC). The local regulatory authority, ACOREP, has already approved the Phase II clinical trial, subject to the completion of certain remaining requirements. The company reported that most of these conditions have been satisfied and is now focused on final site readiness and documentation necessary to formally launch the trial. Management stated that current funding is sufficient to execute and complete the planned Phase II study in the DRC according to its projections. In parallel, NanoViricides has filed an application for Orphan Drug Designation for “NV-387 as a Treatment for MPox” with the U.S. Food and Drug Administration Office of Orphan Products Development. If granted, orphan designation would provide incentives including tax credits for qualified clinical trial expenses, exemption from certain regulatory user fees, and the potential for seven years of market exclusivity following regulatory approval. MPox is caused by infection with the MPXV virus, an orthopoxvirus. Currently, there is no drug specifically approved for the treatment of MPox. NV-387 has demonstrated strong antiviral effectiveness in a mouse model of dermal lethal infection using ectromelia virus, an orthopoxvirus closely related to the viruses responsible for smallpox and MPox. The company also noted that NV-387 has successfully completed a Phase I human clinical trial, demonstrating safety and tolerability in healthy adults with no reported adverse events. Based on these results and preclinical efficacy data, NanoViricides believes NV-387 represents a promising clinical candidate for the treatment of MPox as it advances into mid-stage human trials. #proactiveinvestors #nanoviricidesinc #nyseamerican #nnvc #measles #nanoviricides #NV387 #OrphanDrugDesignation #AntiviralTherapy #ClinicalTrials #PhaseII #OrphanDrugDesignation #FDA #DrugDevelopment #InfectiousDisease #BiotechInnovation #GlobalHealth #Orthopoxvirus #BroadSpectrumAntiviral #PharmaUpdate #EmergingDiseases #HealthcareInnovation #ClinicalResearch