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Clinical Trial of the Oral Drug NV-387 to Treat Ebola to Start Next Week, Hoping to Reduce Fatalities and Spread, As the Largest Ebola Outbreak is Expanding in DR Congo with 48% Crude Fatality Rate, Says NanoViricides

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  • NanoViricides, Inc. announced its Phase II clinical trial for the oral drug NV-387 Oral Gummies is scheduled to begin next week in the Ituri province of the Democratic Republic of Congo (DRC).
  • The trial targets the Bundibugyo Ebolavirus, which has caused an unprecedented outbreak with a crude fatality rate of approximately 48% and no existing approved treatment or vaccine.
  • As of September 10, 2026, the DRC outbreak recorded 7,022 confirmed cases, 3,398 confirmed deaths, and 1,671 recoveries, making it the largest and fastest-growing Ebola outbreak in the region.
  • NV-387 is an orally administered broad-spectrum antiviral that mimics the host cell surface feature (HSPG) required by viruses for infection, theoretically preventing viral escape through mutation unlike antibody-based therapies.
  • The current "PARTNERS" trial involves infusions of monoclonal antibody cocktails or Remdesivir, which are considered unscalable in resource-poor areas and pose higher risks to healthcare workers compared to oral administration.
  • Animal studies previously showed NV-387 Oral was superior to intravenous Remdesivir in extending survival in lethal coronavirus infection models.
  • The Phase II trial, registered under PACTR202608748555077, is a single-arm safety and dose run-in (Phase IIA) followed by a randomized, controlled efficacy evaluation (Phase IIB) led by principal investigator Prof. Patrick de Marie Chimusa Katoto.
  • Om Sai Clinical Research Private Limited serves as the Contract Research Organization (CRO) for the trial, collaborating with the University of Bukavu and local experts.
  • The outbreak has spread to at least six provinces in DRC, threatens South Sudan, and is present in displacement camps hosting over 4.4 million people, with over 80% of new cases occurring outside known contact lists.
  • At least 43 healthcare workers have died and 160 have contracted the disease, highlighting the critical need for safe, scalable treatments that minimize exposure risks.
  • Schools have reopened in affected regions with strict hygiene protocols, though the case fatality rate for children is estimated at 60%, higher than the adult rate.
  • The US CDC reports minimal risk to the USA but has imposed strict travel restrictions, quarantine requirements, and screening measures for travelers from Central Africa.
  • NanoViricides' NV-387 is positioned as the only oral drug in clinical trials for this outbreak, contrasting with other candidates like obeldesivir (used only for prevention) and the infusion-based therapies in the PARTNERS trial.
  • The Bundibugyo virus outbreak was declared a Public Health Emergency of International Concern by the WHO on May 17, 2026, and is projected to potentially exceed the 2014-2016 West Africa outbreak in total cases and deaths.