NanoViricides Begins Dosing Oral NV-387 Gummies in Phase II Ebola Trial in DRC
核心洞察
NanoViricides has started enrolling and dosing patients in a Phase IIA/IIB trial of oral NV-387 gummies for Bundibugyo Ebola virus disease (搜索) in Ituri province, DRC.
The adaptive trial begins with a single-arm safety and dose run-in from September 23, 2026, followed by a randomised, controlled, open-label Phase IIB efficacy evaluation.
NV-387 mimics heparan sulfate proteoglycan (搜索), the host attachment receptor used by all Ebola viruses, a mechanism the company says the virus cannot escape by mutation.
NanoViricides has begun enrolling and dosing patients in a Phase II clinical trial of NV-387 Oral Gummies as a treatment for the Bundibugyo ebolavirus (搜索) and other Ebola viruses in the Democratic Republic of Congo. Enrollment and dosing in the Phase IIA portion started on or about September 23, 2026 at an Ebola Treatment Center in Ituri province, the company said on September 28, 2026.
The trial is registered in the Pan African Clinical Trials Registry under the identifier PACTR202608748555077. Its registered title describes an adaptive, multi-centre Phase IIA/IIB design of NV-387 oral gummies plus optimised supportive care in adults with Ebola virus disease (搜索) caused by Bundibugyo or other orthoebolaviruses. The Phase IIA stage is a single-arm safety and dose run-in; the Phase IIB stage is a randomised, controlled, open-label efficacy evaluation with independent blinded-endpoint adjudication. Prof. Patrick de Marie Chimusa Katoto is listed as principal investigator.
Dose Finding Before Randomisation
The Phase IIA portion is designed to establish an NV-387 dosing protocol that is safe and well tolerated within the context of disease symptoms and severity. The company states the aim is maximum feasible dosing while avoiding non-tolerable adverse events, given the high fatality rate of Ebola Bundibugyo virus disease, in order to make maximum impact on the infecting virus. The dosage protocol reached in Phase IIA, stratified by disease severity, will be fixed for use across patients in Phase IIB, which is designed to evaluate safety, tolerability and effectiveness of the gummies against ebolavirus infection.
"Our DRC Team and the CRO are committed to contribute to produce the best results for the patients, hoping to maximize survival," said Anil R. Diwan, PhD, president of NanoViricides. He added that NV-387 as an oral treatment could make a great contribution to combatting current and future Ebola outbreaks if found to be effective.
The company describes EVD/BVD severity as stratified into a Dry Stage, with fever, aches, pains and fatigue that can be confused with other infections, and a Wet Stage marked by explosive vomiting and diarrhea. The Wet Stage may progress to a Critical Stage requiring intensive care and carrying a high fatality rate. Unexplained bleeding may occur in the Wet or Critical stages. Patients remain infectious from the dry stage until full recovery, and recovery is slow.
Mechanism and the Oral Route
NV-387 is a broad-spectrum antiviral that mimics heparan sulfate proteoglycan (搜索), the host-side feature that over 90 to 95 percent of human pathogenic viruses require to infect cells. According to the company, the virus continues to use HSPG regardless of how much it changes in the field, so it cannot escape the drug. All Ebola viruses use HSPG as the attachment receptor before entering the cell; after entry inside endosomes, the ebolavirus surface glycoprotein is substantially degraded, exposing its binding site for the NPC1 (搜索) receptor and allowing entry into the cytoplasm where replication begins.
The gummies dissolve in the mouth without swallowing effort or water, which the company says simplifies delivery for patients with swallowing difficulties. NanoViricides states that NV-387 is currently the only orally administered drug in clinical trials for this outbreak to its knowledge.
By contrast, remdesivir is a small molecule inhibitor of the viral RDRP enzyme needed to copy the viral genome, and the virus can potentially escape it through a small number of mutations. The company also argues that antibodies are highly specific to a particular strain and are readily escaped by field mutations, citing the loss of efficacy of antibody drugs granted emergency use authorisation during the COVID-19 pandemic as SARS-CoV-2 mutated. It remains to be seen whether and for how long MBP134 remains effective in the current outbreak, even if it is found effective and approved.
In animal studies of a lethal coronavirus infection model conducted when NV-387 was originally developed for COVID-19, oral NV-387 was found superior to intravenous remdesivir in extending survival of lethally infected animals. On that basis the company believes oral NV-387 can reasonably be expected to provide superior activity compared with at least remdesivir infusion, which is already being tested in the PARTNERS trial.
"Comparing NV-387 to currently available therapeutics under study leads us to rationally anticipate at least partial success in the proposed clinical trial," Diwan said, cautioning that data from the trial will determine whether NV-387 is effective and can become an important pillar in the response to the outbreak in DRC.
A Trial Landscape Built on Infusions
The PARTNERS trial, which began on July 2, 2026, is evaluating two drugs that both require infusion delivery. Approximately 300 patients have been enrolled across four groups: infusion of the monoclonal antibody cocktail MBP134, infusion of remdesivir, infusion of MBP134 plus remdesivir, and a control group receiving local standard of care. NanoViricides notes that infusions are inherently unscalable for the extent of the current outbreak in resource-poor areas of DRC, and that infusion treatment increases risks to health care workers through needle-sticks, patient handling and possible blood exposure. PARTNERS will require more than 1,000 patients treated and may not yield results for several months.
A similar large collaborative effort during the 2014-2016 West Africa outbreak resulted in US FDA approval of two antibody drugs specifically for Ebola Zaire, which are not deemed useful in the current outbreak without further clinical trials. Three different vaccines are also expected to enter efficacy trials within months, according to the WHO. Ervebo, developed for Ebola Zaire, is being deployed under a research protocol to health care workers, and its efficacy against BDBV needs evaluation in a clinical trial, according to the WHO.
NanoViricides has retained Om Sai Clinical Research Private Limited (搜索), India, as contract research organisation for the trial. Om Sai CRO assembled the team with Prof. Katoto and other experts, with support from the University of Bukavu (搜索) and partners in the Ebola-affected region.
Outbreak Scale and Operational Constraints
The current outbreak, caused by Bundibugyo ebolavirus (搜索), is the largest and fastest growing Ebola outbreak in DRC. As of September 23, 2026, the WHO daily report recorded 7,890 confirmed cases, 3,799 confirmed deaths and 1,966 confirmed recoveries in DRC, against 4,945 confirmed cases and 2,325 confirmed deaths as of August 14, 2026. The crude case fatality rate is about 48 percent. Using the ratio of confirmed deaths to confirmed deaths plus confirmed recoveries, the probability of death is about 67 percent, with roughly one third of patients recovering.
The outbreak is on track to exceed the 2014-2016 Ebola Zaire outbreak in West Africa, where 28,616 cases and 11,310 deaths were recorded across Guinea, Liberia and Sierra Leone, according to the WHO. It is present in at least six provinces in DRC and is threatening South Sudan. More than 80 percent of new cases are outside known contact lists, leading to a projection that the true extent of the outbreak is at least twice the reported confirmed cases. Ebola has also spread into displacement camps hosting over 4.4 million displaced people, a population with poor drinking water, sanitation and medical resources.
There is no approved treatment or vaccine for the new variant of Bundibugyo ebolavirus (搜索) causing the outbreak, which appears to be freshly introduced from an animal source such as fruit bats. The WHO declared the outbreak a Public Health Emergency of International Concern on May 17, 2026. It arose in a high-traffic region bordering DRC, with travel contacts to Uganda and South Sudan and 11 more African nations at risk.
Children face a crude case fatality rate of 60 percent, higher than the sub-50 percent rate in adults, and schools have reopened across affected regions with hygiene measures such as hand sanitisers and frequent hand washing. At least 43 health care workers have died from Ebola and at least 160 have contracted the disease.
Expanding travel restrictions and limited availability of personal protective equipment and diagnostic kits, compounded by those restrictions, have caused delays in the trial effort, and the company anticipates such delays to continue given the outbreak situation. The CDC's models suggested the outbreak could grow to 10,000 to 20,000 cases and 2,000 to 4,000 deaths within three months; the company notes the outbreak appears more aggressive than that model, with over 2,000 deaths in less than three months, over 4,000 confirmed cases and over 10,000 estimated total cases.
Ebolaviruses spread through bodily fluid secretions including fomites and sputum as well as semen and genital secretions. Virus can persist in survivors for as long as 965 days without symptoms and can transmit through bodily secretions, suggesting possible latency, with sexual transmission documented as late as 482 days after disease. Persistence in immune-privileged organs such as the brain, eyes and gonads, where antibodies are not operative, makes the virus a serious threat for sustained outbreaks. Ebolaviruses are not believed to transmit via respiratory droplets or aerosols and require extensive contact with bodily fluids, and quarantine measures for travel from outbreak areas are in place, so there is currently no apparent threat of a global pandemic.
If NV-387 is found effective against Bundibugyo virus, the company states it will likely be effective against all ebolaviruses and possibly all filoviruses. Previous anti-Ebola efforts have focused on vaccines and antibodies, producing therapies specific to Ebola Zaire and leaving Sudan, Marburg and the rarer Bundibugyo viruses without treatment or vaccine.
"Only safe and effective broad-spectrum antiviral drugs like NV-387 that can effectively tackle most viral infections will enable the world to combat viruses and defend the global population," Diwan said, adding that NV-387 is the only drug in clinical development with such broad-spectrum potential against diverse epidemics such as Mpox and Ebola to the company's knowledge.