NanoViricides to Start Phase II Oral Ebola Trial in DRC
核心洞察
NanoViricides' Phase II trial of oral NV-387 gummies for Bundibugyo Ebolavirus (搜索) is scheduled to start next week at an Ebola Treatment Center in Ituri province, DRC.
The adaptive Phase IIA/IIB trial combines a single-arm safety and dose run-in with a randomized, controlled, open-label efficacy evaluation with blinded-endpoint adjudication.
The ongoing Bundibugyo outbreak is the largest and fastest-growing Ebola outbreak in DRC, with 7,022 confirmed cases and 3,398 confirmed deaths as of September 10, 2026.
NanoViricides, Inc. (NYSE American:NNVC) announced that its Phase II clinical trial of NV-387 oral gummies as a treatment for Bundibugyo Ebolavirus (搜索) and other Ebola viruses in the Democratic Republic of Congo is scheduled to begin next week at an Ebola Treatment Center in Ituri province. The trial is titled an adaptive, multi-centre Phase IIA/IIB study of NV-387 oral gummies plus optimised supportive care in adults with Ebola virus disease (搜索), comprising a single-arm safety and dose run-in followed by a randomised, controlled, open-label efficacy evaluation with independent blinded-endpoint adjudication. It is registered in the Pan African Clinical Trials Registry under PACTR202608748555077, with Om Sai CRO leading execution.
The company positions NV-387 as the only orally administered drug in clinical trials for Ebola, contrasting it with the WHO-organized PARTNERS trial, which is evaluating infused MBP134 monoclonal antibody cocktail and infused remdesivir, alone and in combination, against local standard of care in approximately 300 enrolled patients. NanoViricides states that infusions are inherently unscalable in resource-poor settings and increase risks to health care workers through needle-sticks and blood exposure. NV-387 mimics heparan sulfate proteoglycan (搜索), a host-side feature required by over 90-95% of human pathogenic viruses, which the company argues Ebola viruses cannot escape, unlike antibodies such as MBP134 that are readily overcome by mutation.
The Bundibugyo outbreak is now the largest and fastest-growing Ebola outbreak in DRC, with 7,022 confirmed cases, 3,398 confirmed deaths and 1,671 recoveries as of September 10, 2026, and a crude case fatality rate of about 48%. The company notes that no approved treatment or vaccine exists for the Bundibugyo variant, that at least 43 health care workers have died and 160 have contracted the disease, and that over 80% of new cases occur outside known contact lists. The outbreak was declared a Public Health Emergency of International Concern by the WHO on May 17, 2026.