NanoViricides, Inc. (NYSE American: NNVC), a clinical-stage company developing antiviral drugs, announced that a Phase II clinical trial of NV-387 Oral Gummies for the treatment of the current Bundibugyo Ebolavirus and other Ebola viruses is expected to begin soon in the Democratic Republic of Congo (DRC). The company has received regulatory approval from the local agency ACOREP to initiate the trial and has appointed Professor Patrick Katoto as principal investigator. Preparatory work, including staff training, is underway, and the NV-387 drug product is already available in the DRC, with first patient dosing anticipated within a few weeks, barring outbreak-related impediments.
NV-387 is an orally administered broad-spectrum antiviral designed to mimic host-side features required by viruses for infection. NanoViricides believes oral delivery could offer advantages in resource-limited outbreak settings compared with treatments requiring infusions. This is particularly relevant in the DRC, where healthcare infrastructure may be strained during Ebola outbreaks. The company has engaged Om Sai Clinical Research Private Limited as the contract research organization (CRO) for this Phase II trial, as well as for its planned Phase II trial of NV-387 Oral Gummies for the treatment of Mpox in the DRC.
The significance of this trial extends beyond the immediate outbreak. Ebola viruses, including the Bundibugyo strain, cause severe hemorrhagic fever with high mortality rates. Current treatments often require intravenous administration, which can be challenging in remote or resource-limited settings. An oral formulation like NV-387 could simplify administration, potentially allowing more patients to receive timely treatment. Furthermore, NV-387's broad-spectrum activity suggests it may also be effective against other viral threats, including Mpox, which has recently emerged as a global concern.
NanoViricides is a clinical-stage company focused on creating special purpose nanomaterials for antiviral therapy. Its lead drug candidate, NV-387, is being developed for multiple indications, including RSV, COVID-19, influenza, and Mpox. The company holds a worldwide exclusive perpetual license to TheraCour nanomedicine technology for several viruses, including Ebola and Marburg viruses. This trial in the DRC is a critical step in advancing NV-387 toward potential approval and availability for patients in need.
The company's broader pipeline includes NV-CoV-2, a COVID-19 candidate, and NV-HHV-1 for shingles. NanoViricides has stated that drug development is lengthy and requires substantial capital, and there can be no assurance that its candidates will prove effective and safe in human trials. Nevertheless, the initiation of this Phase II trial marks a notable progress point for the company and for the fight against Ebola.
For more information, visit the company's newsroom at https://ibn.fm/NNVC. The full press release can be viewed at https://ibn.fm/uWVTo.
