NanoViricides, Inc. (NYSE American: NNVC), a clinical-stage company focused on antiviral drug development, has announced that it expects to begin a Phase II clinical trial of NV-387 Oral Gummies for the treatment of the current Bundibugyo Ebolavirus and other Ebola viruses in the Democratic Republic of Congo (DRC) imminently. The company has received regulatory approval from the local agency ACOREP and has appointed Professor Patrick Katoto as the principal investigator. Preparatory work, including staff training, is underway, and the NV-387 drug product is already available in the DRC. First patient dosing is anticipated within a few weeks, barring any outbreak-related impediments.
NV-387 is an orally administered broad-spectrum antiviral designed to mimic host-side features that viruses require for infection. The company believes that oral delivery could offer significant advantages in resource-limited outbreak settings compared to treatments requiring intravenous infusions. This could be particularly beneficial in the DRC, where healthcare infrastructure may be constrained during Ebola outbreaks. Om Sai Clinical Research Private Limited is serving as the contract research organization (CRO) for this Phase II trial, as well as for the company's planned Phase II trial of NV-387 Oral Gummies for the treatment of Mpox in the DRC.
The initiation of this trial marks a critical step in addressing Ebola outbreaks, which have historically posed severe public health threats in Central and West Africa. The Bundibugyo strain, one of the less common but deadly Ebola viruses, has caused sporadic outbreaks with high mortality rates. An oral treatment could simplify logistics, reduce the need for trained medical personnel for administration, and improve patient compliance, potentially leading to better outcomes in outbreak containment.
NanoViricides' lead drug candidate, NV-387, is also being developed for other viral infections, including RSV, COVID-19, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox and Measles. The company's advanced drug candidate, NV-HHV-1, targets Shingles. The company's technology platform is based on nanomedicine, creating special purpose nanomaterials for antiviral therapy. NanoViricides holds exclusive licenses to this technology for several viruses, including Ebola/Marburg viruses, from TheraCour Pharma, Inc.
The approval from ACOREP and the appointment of a local principal investigator underscore the collaborative effort to conduct clinical research in the DRC. This trial will provide valuable data on the safety and efficacy of NV-387 in treating Ebola, which could pave the way for broader regulatory approvals and potential use in future outbreaks. The availability of an oral antiviral for Ebola could be a game-changer in global health security, especially in regions where intravenous therapies are not readily accessible.
For more information on this development, the full press release can be viewed at https://ibn.fm/uWVTo. Additionally, the latest news and updates regarding NanoViricides are available in the company's newsroom at https://ibn.fm/NNVC.
