NNVC News & Events

NanoViricides updated that it has continued to advance its broad-spectrum antiviral drug NV-387 towards a Phase II Clinical Trial of the NV-387 Oral Gummies formulation as a Treatment for the Current Bundibugyo Ebolavirus in the Democratic Republic of Congo. The company said, "NanoViricides has already put together a team with a renowned Principal Investigator and with support from a well known University in the Ebola-affected region for the execution of this clinical trial after regulatory approvals. NanoViricides' proposal for the said clinical trial has been approved by the Pillar Committee in Charge in the DRC...NanoViricides has retained Om Sai Clinical Research Private Limited, India, as the CRO for the Phase II Mpox clinical trial in DRC previously. Om Sai CRO has been instrumental in putting together a team of renowned experts to lead and execute the clinical trial of NV-387 as a treatment for Ebolaviruses in DRC. The next steps for NanoViricides will be to perform appropriate submissions to the National Ethics Committee of DRC, and upon their approval, to submit a clinical trial application to the regulatory agency, ACOREP for approval to begin the clinical trial. Most of these documents are ready because the same drug NV-387 Oral Gummies has been approved by ACOREP for a Phase II clinical trial as a Treatment for Mpox in DRC."

NanoViricides announced that its clinical stage, broad-spectrum, antiviral drug NV-387 has been granted a "Rare Pediatric Disease Drug" Designation by the US FDA Office of Orphan Products Development. This RPDD designation enables that a Priority Review Voucher can be issued to the Company upon a successful Marketing Application for the use of NV-387 as a treatment for Measles, provided all of the required conditions are met. The Company can use the PRV, if granted, to reduce review times on another of its drug applications. Importantly, a PRV can be sold to another Pharma Company for accelerating their drug program as well, which provides a high value to the purchaser. Recently, a PRV has been sold for $195M. Sale of a PRV can bring cash to the Company even prior to revenues from commercialization of a drug product.

The Centers for Disease Control raised its response to the Ebola outbreak in the Democratic Republic of Congo to its highest level on Friday , but said the risk of Ebola's spread in the U.S. remained low, reported Reuters. Companies working on Ebola testing and defense solutions include NanoViricides (NNVC), GeoVax Labs (GOVX) and Co-Diagnostics (CODX).