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The Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for Ebola in DR Congo to Fight the Current Largest Ever and Expanding Ebola Outbreak to Begin Soon

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  • NanoViricides, Inc. announced that its Phase II clinical trial for NV-387 Oral Gummies as a treatment for the current Bundibugyo Ebolavirus & other Ebola viruses is expected to begin soon in the Democratic Republic of Congo (DRC).
  • Professor Patrick Katoto, Co-Director of the Centre for Tropical Diseases & Global Health, has been appointed as the principal investigator to lead the trial after receiving regulatory approval from the local agency ACOREP.
  • Preparatory work, including staff training, has already commenced to accelerate the time to first patient dosing, with the first dosing anticipated within a few weeks barring outbreak impediments.
  • The drug product is already available in the DRC, having been shipped for an impending Phase II trial for Mpox, ensuring immediate availability for the Ebola trial.
  • As of August 14, 2026, the outbreak is the largest & fastest-growing Ebola outbreak in DRC history with 4,945 confirmed cases, 2,325 deaths, & a crude case fatality rate of 46%.
  • Over 80% of new cases are outside known contact lists, suggesting the actual outbreak size is at least double the confirmed numbers, with the virus now present in six provinces & threatening South Sudan.
  • NV-387 is an orally active broad-spectrum antiviral that mimics host-side features required by viruses, making it unlikely for viruses to escape, unlike antibody treatments or Remdesivir which target specific viral enzymes.
  • Unlike other treatments requiring infusions, NV-387 is delivered orally & dissolves in the mouth, offering a scalable solution for resource-limited settings & patients with swallowing difficulties.
  • Current limitations on travel, PPE, & diagnostic kits due to the outbreak are causing delays, although the trial aims to validate the drug quickly to minimize further spread.
  • Competing efforts like the "PARTNERS" trial involve infusions of Remdesivir & antibody cocktails, which may take over a year to yield results & are specific to certain strains.
  • The Company believes NV-387 could be revolutionary against the Bundibugyo virus, for which no approved treatment or vaccine currently exists.
  • CDC models initially suggested the outbreak could reach 10,000 to 20,000 cases, but actual numbers have already exceeded 4,000 confirmed cases with over 2,000 deaths in less than three months.
  • The outbreak was declared a Public Health Emergency of International Concern (PHEIC) by the WHO on May 17, 2026, with 11 African nations at risk due to travel contacts.
  • NanoViricides has retained Om Sai CRO to lead the trial in collaboration with local experts & the University of Bukavu.
  • The company emphasizes that while a global pandemic is not currently apparent due to high fatality rates limiting spread, a variant with lower fatality could pose a significant global threat.
  • Travel restrictions & quarantine requirements have been implemented in the USA & other regions to prevent the virus from entering the general population.