NanoViricides Advances NV-387 Toward Phase II Trial for Bundibugyo Ebola in DRC

NanoViricides has secured Pillar Committee approval to advance its investigational oral antiviral NV-387 Oral Gummies into a Phase II clinical trial for Bundibugyo Ebola virus disease (BDBV) in the Democratic Republic of Congo (DRC), with ethics and regulatory submissions now underway. The company is preparing applications for review by the DRC National Ethics Committee, followed by submission to ACOREP, the country’s medicines regulatory authority, before patient enrollment can begin.

Growing Outbreak Underscores Urgent Need

The clinical program advances as the Bundibugyo Ebola outbreak continues to expand across Central Africa. According to figures cited by the company, the DRC had reported 1,561 confirmed cases and 506 deaths as of July 6, up from more than 1,400 cases and 438 deaths just four days earlier. Unlike the Zaire Ebola virus, which has approved antibody-based therapies, no approved treatment or vaccine is currently available for Bundibugyo Ebola virus, leaving supportive care as the primary management strategy.

Host-Targeted Antiviral Strategy

The lack of approved therapies has renewed interest in antiviral approaches that extend beyond strain-specific antibodies. NV-387 takes a different approach by targeting host-virus interactions rather than viral proteins. The investigational candidate mimics heparan sulfate proteoglycan (HSPG), a host-cell attachment factor used by many pathogenic viruses during the earliest stage of infection. By interfering with viral attachment instead of targeting viral antigens directly, the company believes the therapy could retain activity despite viral mutations and potentially provide activity across multiple filoviruses, including Bundibugyo, Sudan, Marburg and other Ebola viruses.

Oral Therapy Enters a Competitive Development Landscape

NV-387 is formulated as an oral gummy that dissolves in the mouth without water, eliminating the need for intravenous administration and potentially simplifying treatment in resource-limited outbreak settings. The candidate enters a competitive development landscape in which the World Health Organization’s PARTNERS trial is evaluating the monoclonal antibody cocktail MBP134, alone and in combination with remdesivir, for Bundibugyo Ebola virus disease. Unlike these infusion-based investigational therapies, NV-387 is being developed as an orally administered antiviral.

Phase II Preparations Continue

NanoViricides has assembled a clinical research team led by an experienced principal investigator in collaboration with a university in the Ebola-affected region and has retained Om Sai Clinical Research Pvt. Ltd. as the contract research organization supporting the study. The company said much of the regulatory documentation is already available because the same NV-387 Oral Gummies formulation previously received authorization for a Phase II mpox trial in the DRC, and investigational drug supplies have already been shipped to the country.

Path Forward

NanoViricides previously reported that NV-387 demonstrated superior activity to remdesivir in a lethal preclinical viral disease model, although this has not been established in Ebola patients. Commenting on the program, President and Executive Chairman Dr. Anil R. Diwan said an orally administered antiviral could address practical limitations associated with infusion-based therapies during Ebola outbreaks.

Pending approval from the National Ethics Committee and ACOREP, the Phase II study will evaluate the safety and efficacy of NV-387 in patients with Bundibugyo Ebola virus disease. Positive clinical results could provide the first evidence supporting a host-targeted oral antiviral strategy for filoviruses, where treatment options remain limited despite ongoing advances in antibody-based therapies.

Reference

As the Ebola Epidemic Spreads, NanoViricides Advances Towards a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for Ebola in DR Congo