NanoViricides’ NV-387 Oral Gummies Set for Phase II Ebola Trial in DRC, Offering Potential Oral Treatment Advantage

NanoViricides, Inc. (NYSE American: NNVC), a clinical-stage company focused on antiviral drug development, has announced that its Phase II clinical trial of NV-387 Oral Gummies for the treatment of the current Bundibugyo Ebolavirus and other Ebola viruses is expected to commence soon in the Democratic Republic of Congo (DRC). The company has received regulatory approval from the local agency ACOREP and has appointed Professor Patrick Katoto as the principal investigator. Preparatory activities, including staff training, are 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 oral delivery method could offer significant advantages in resource-limited outbreak settings compared with treatments that require infusions, which often demand trained personnel and cold-chain logistics. This is particularly relevant in the DRC, where healthcare infrastructure can be strained during Ebola outbreaks.

The trial will be conducted with Om Sai Clinical Research Private Limited serving as the contract research organization (CRO), which will also support the company’s planned Phase II trial of NV-387 Oral Gummies for Mpox in the DRC. This dual application underscores the broad-spectrum potential of NV-387, which is also being developed for other viral infections such as RSV, COVID-19, and influenza.

The announcement is significant because it marks progress in bringing an oral antiviral to combat Ebola, which historically has been treated with intravenous therapies. Oral administration could simplify treatment delivery, reduce the burden on healthcare workers, and improve patient compliance, especially in remote areas. If successful, NV-387 could become a valuable tool in managing not only Ebola but also other viral outbreaks, including Mpox.

According to the company, NV-387 is designed to mimic host cell surface features, allowing it to bind to viruses and neutralize them. This mechanism is distinct from traditional antivirals that target viral enzymes. The drug candidate has already shown promise in preclinical studies, and the company is advancing it through clinical development.

The DRC has experienced multiple Ebola outbreaks, and the current Bundibugyo strain poses a significant threat. The initiation of this trial is a critical step in evaluating the safety and efficacy of NV-387 in a real-world outbreak setting. The company’s ability to secure regulatory approval and logistical support in the DRC demonstrates its commitment to addressing global health challenges.

NanoViricides' broader pipeline includes NV-HHV-1 for shingles and other candidates for various viral diseases. The company’s technology platform is based on nanomedicine, which enables targeted delivery of antiviral agents. The success of NV-387 in clinical trials could validate this platform and pave the way for additional indications.

Investors and public health officials will be watching this trial closely. If NV-387 proves effective, it could revolutionize Ebola treatment and potentially be deployed in future outbreaks, saving lives and reducing the economic and social impact of these devastating diseases.