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NanoViricides Registers Phase II Ebola Trial in DRC After Regulatory Approval

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FAQSIR News Desk
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NanoViricides, Inc. (NYSE American: NNVC) says its Phase II clinical trial of NV-387 oral gummies for Ebola virus disease has been registered in the Pan African Clinical Trials Registry and approved to begin by ACOREP, the local regulatory agency in the Democratic Republic of Congo (DRC). The announcement concerns the current Bundibugyo ebolavirus outbreak and other Ebola viruses.

#Trial registration and design

The study is listed under identification number PACTR202608748555077. It is planned as an adaptive, multi-centre trial involving adults with Ebola virus disease.

The first part, Phase IIA, is a single-arm safety and dose run-in. Phase IIB is designed as a randomised, controlled and open-label efficacy evaluation, with independent blinded-endpoint adjudication. NV-387 oral gummies would be administered alongside optimised supportive care.

Professor Patrick de Marie Chimusa Katoto is listed as the principal investigator. NanoViricides has retained Om Sai Clinical Research Private Limited of India as the contract research organisation for the study.

#Patient dosing has not yet started

The company says the NV-387 drug product has been shipped to and received at the clinical trial site in Ituru province. It anticipates that the first patient could be dosed within one to two weeks, provided the outbreak does not create impediments. The announcement does not state that dosing has begun.

NanoViricides also reports that travel restrictions and limited supplies, including personal protective equipment and diagnostic kits, have already delayed trial-related work. The company expects the operational difficulties to continue as the outbreak develops.

#Reported scale of the Ebola outbreak

According to figures cited in the announcement, the DRC had 6,604 confirmed cases and 3,175 deaths as of September 5, 2026. The reported crude fatality rate had risen to 48%.

The announcement says the outbreak had reached at least six provinces in the DRC and was threatening South Sudan. It also reports that at least 43 healthcare workers had died and at least 160 had contracted Ebola.

The company says there is no approved treatment or vaccine for the new Bundibugyo ebolavirus variant associated with the current outbreak. It describes the need for an oral treatment option in settings where infusion-based therapies may be difficult to deliver, but the trial is intended to evaluate whether NV-387 is safe and effective; no clinical efficacy results for this outbreak are reported.

#Other Ebola interventions

The announcement refers to the PARTNERS clinical trial, which is evaluating remdesivir infusion, an antibody cocktail known as MBP134, and the combination of MBP134 with remdesivir. It says about 300 patients had been enrolled across four groups, according to the World Health Organization, and that the study would require over 1,000 patients to be treated.

It also notes that three vaccines were expected to enter efficacy trials within months. Therapies previously approved for Ebolavirus Zaire are described as requiring further clinical trials before being considered for the current Bundibugyo outbreak.

#Development risks and company statements

NanoViricides says NV-387 had previously been found to be superior to remdesivir in a lethal animal model of a viral disease. The company believes that finding may extend to the current Bundibugyo strain, but the announcement does not provide human clinical results for NV-387 against Ebola.

The company states that pharmaceutical development is lengthy and requires substantial capital. It also says there can be no assurance that its drug candidates will demonstrate sufficient safety or effectiveness for human clinical development or become successful pharmaceutical products. Statements about safety and effectiveness in the announcement refer to research findings and do not represent an evaluation by the US Food and Drug Administration.

#Key Takeaways

  • NanoViricides says its Phase II NV-387 Ebola trial was registered under PACTR202608748555077.
  • ACOREP has approved the trial to begin in the Democratic Republic of Congo.
  • The study combines a Phase IIA safety and dose run-in with a Phase IIB controlled efficacy evaluation.
  • NV-387 has reached the clinical trial site, but patient dosing has not been reported as started.
  • The announcement reports 6,604 confirmed cases and 3,175 deaths in the DRC as of September 5, 2026.

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Frequently Asked Questions

NanoViricides, Inc. (NYSE American: NNVC) says its Phase II clinical trial of NV-387 Oral Gummies for Bundibugyo Ebolavirus and other Ebola viruses in the Democratic Republic of Congo was registered in the Pan African Clinical Trials Registry database. The trial identification number is PACTR202608748555077. The company also says it has received regulatory approval to begin the trial from ACOREP in the Democratic Republic of Congo.
The registered trial is described as an adaptive, multi-centre Phase IIA/IIB study in adults with Ebola virus disease. It includes a single-arm safety and dose run-in in Phase IIA, followed by a randomised, controlled, open-label efficacy evaluation with independent blinded-endpoint adjudication in Phase IIB. Prof. Patrick de Marie Chimusa Katoto is listed as the principal investigator.
The source says NV-387 Oral Gummies were shipped to and received at the clinical trial site in Ituri province. It says first patient dosing can be expected within one to two weeks, barring impediments caused by the Ebola outbreak. This describes an anticipated event rather than completed dosing, and the source does not report that dosing has started.
NanoViricides says limitations on travel, and limited availability of resources such as personal protective equipment and diagnostic kits, have caused delays and are expected to continue causing delays because of the outbreak situation. The source also says the company anticipates further delays as the outbreak continues to expand.
According to the source, as of September 5, 2026, there were 6,604 confirmed cases and 3,175 deaths in the Democratic Republic of Congo, with a crude fatality rate of 48%. The source says the outbreak was present in at least six provinces in the Democratic Republic of Congo and was threatening South Sudan. It also states that at least 43 healthcare workers had died and at least 160 had contracted the disease.
The source describes the rationale for evaluating NV-387 and refers to previous findings in a lethal animal model, but it does not report clinical efficacy results for NV-387 against the current Bundibugyo Ebola outbreak. The company says it believes NV-387 could be effective, but also states that there can be no assurance that its pharmaceutical candidates will show sufficient effectiveness and safety for human clinical development or become successful pharmaceutical products.
The company states that pharmaceutical development is extremely lengthy and requires substantial capital. It says outcomes depend on regulatory approvals, external collaborators and consultants, and successful development and commercialisation. The release also says actual events could differ materially from forward-looking statements because of known and unknown risks and uncertainties, and that statements about safety and effectiveness refer to research findings and do not indicate evaluation by the US FDA.