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Phase II Clinical Trial of NV-387 Oral Gummies as Treatment of Ebola Progressing Well, Says NanoViricides

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  • NanoViricides, Inc. reports its Phase IIA clinical trial for NV-387 Oral Gummies to treat Ebola Bundibugyo virus (BDBV) infection in the Democratic Republic of Congo is progressing well.
  • The trial evaluates different dosage regimens for patients in "Dry Stage" and "Wet Stage" of the disease, anticipating enrollment of primarily severe "Wet Stage" patients with vomiting.
  • The study assesses safety, tolerability, and the duration of drug tolerance over 6 to 12 days, with treatment stopping once viral load becomes undetectable.
  • Efficacy is not statistically evaluated in this Phase IIA segment; however, an efficacy signal may be observed if treated patient outcomes significantly differ from the historical 67% to 75% Infection Fatality Rate (IFR) in the region.
  • The Phase IIA trial involves up to 20 subjects, and results will determine if the drug proceeds to a randomized, controlled Phase IIB trial.
  • The current BDBV outbreak in DRC has recorded 9,000 confirmed cases and 4,339 deaths as of October 10, 2026, with the outbreak expanding into Nord Kivu province where treatment capacity is limited.
  • NV-387 is a broad-spectrum antiviral that mimics host-side heparan sulfate proteoglycan (HSPG), a feature required by over 90-95% of human pathogenic viruses, preventing viral escape via mutation.
  • The oral gummy formulation dissolves in the mouth without water, addressing delivery challenges for patients experiencing severe vomiting.
  • No approved treatments or vaccines currently exist for the new variant of the Bundibugyo Ebolavirus causing this outbreak.
  • The USA has contributed nearly $1.4 billion in humanitarian assistance, including an additional $500 million pledge, to support outbreak containment.
  • Global travel restrictions and screening measures are currently preventing the virus from spreading outside Central Africa, with no immediate threat to the USA.
  • The outbreak was declared a Public Health Emergency of International Concern by the WHO on May 17, 2026, and poses risks to 11 African nations.
  • NanoViricides plans to advance NV-387 for other respiratory viral infections including RSV, Influenza, and COVID-19, while also developing NV-HHV-1 for Shingles.