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Clinical Trial of the Oral Drug NV-387 to Treat Ebola Has Started Enrollment and Dosing of Patients Last Week (on or about September 23rd), Says NanoViricides

NNVC
  • NanoViricides, Inc. has initiated patient enrollment and dosing for its Phase II clinical trial of NV-387 Oral Gummies to treat Bundibugyo Ebola virus disease in the Democratic Republic of Congo.
  • The trial began on September 23, 2026, at an Ebola Treatment Center in Ituri province under the supervision of Principal Investigator Prof. Patrick de Marie Chimusa Katoto.
  • The study is registered in the Pan African Clinical Trials Registry with the unique identification number PACTR202608748555077.
  • The trial design includes a Phase IIA safety and dose run-in phase followed by a Phase IIB randomized, controlled, open-label efficacy evaluation.
  • NV-387 is currently the only orally administered drug in clinical trials for Ebola, offering a scalable alternative to infusion-based treatments like those used in the PARTNERS trial.
  • The current Bundibugyo Ebola outbreak in DRC is the largest and fastest-growing ever recorded, with 7,890 confirmed cases, 3,799 confirmed deaths, and a crude fatality rate of approximately 48% as of September 23, 2026.
  • NV-387 functions as a broad-spectrum antiviral that mimics host cell surface features (HSPG) required by viruses for infection, making it difficult for the virus to escape via mutation unlike antibody-based therapies.
  • The drug is formulated as oral gummies that dissolve in the mouth, simplifying administration for patients with swallowing difficulties or in resource-poor settings.
  • The outbreak has spread to at least six provinces in DRC and threatens South Sudan, with over 80% of new cases occurring outside known contact lists.
  • Schools have reopened in affected regions despite risks, as remote learning is difficult to implement, though children face a higher case fatality rate of 60% compared to adults.
  • At least 43 healthcare workers have died from Ebola, and over 160 have contracted the disease despite the use of personal protective equipment.
  • No approved treatment or vaccine currently exists specifically for the Bundibugyo variant causing this outbreak, while existing vaccines and antibody drugs are primarily effective against the Zaire strain.
  • The CDC has imposed strict travel restrictions on the USA to prevent the introduction of the virus, though the current risk to the US population is assessed as minimal.
  • Om Sai CRO has been retained to execute the trial, collaborating with local experts and the University of Bukavu to navigate logistical challenges and resource limitations.