NanoViricides Announces That Its Phase II Clinical Trial Of NV-387 Oral Gummies As Treatment For Current Bundibugyo Ebolavirus And Other Ebola Viruses In Democratic Republic Of Congo Is Scheduled To Begin Next Week

Clinical trial is scheduled to start at an Ebola Treatment Center in the Ituri province."NV-387 being an oral drug with broad-spectrum antiviral properties, everyone is rooting for it and hoping that it is effective against Ebola in the this clinical trial," said Anil R. Diwan, PhD, President of the Company, adding, "The Bundibugyo virus for which there is no known treatment or vaccine is causing an unprecedented, rapidly spreading, disease outbreak with a crude fatality rate as high as 48%. We hope that NV-387 can help save lives."Currently, a clinical trial called "PARTNERS" was started as of July 2, 20261 to evaluate two drugs that both require delivery by infusion. Approximately 300 patients have already been enrolled in this trial across four groups, namely (i) Infusion of a monoclonal antibody cocktail, MBP134, (ii) Infusion of Remdesivir, (iii) Infusion of MBP134 plus Infusion of Remdesivir, and (iv) a control group with local standard of care.Infusions are inherently unscalable for the extent of the current ebola outbreak in the resource-poor areas in DRC. Additionally, infusion treatment also increases risks to health care workers such as needle-sticks, as well as due to patient handling and possible blood exposure.NV-387 is currently the only orally administered drug in clinical trials to the best of our knowledge, and this is why medical professionals in the field are looking forward to success in the clinical trial of NV-387.Oral NV-387 was compared with Intravenously given Remdesivir given in animal studies of a lethal coronavirus infection model when NV-387 was originally developed as a treatment for COVID-19. NV-387 Oral was found to be superior in extending survival of the lethally infected animals when compared to Remdesivir I.V. in this study. Therefore, the Company believes that NV-387 oral drug can be reasonably expected to provide superior activity compared to at least remdesivir infusion that is already in the PARTNERS clinical trial.Antibodies are easily overcome by viruses in the field, as was experienced during the COVID-19 pandemic. All antibody drugs that received emergency use approvals lost efficacy within a few months due to mutations in the SARS-CoV-2, an RNA virus. Ebola Bundibugyo is an RNA virus with likely similar rates of mutation. It remains to be seen if and how long MBP134 remains effective during the current Ebola outbreak, even if found to be effective and approved, for use.The Bundibugyo virus is highly unlikely to escape NV-387, unlike in the case of antibodies such as MBP134. This is because NV-387 mimics a portion of the cell surface that is essential for all Ebola viruses to cause productive infection, no matter how different they are."Comparing NV-387 to currently available therapeutics under study leads us to rationally anticipate at least partial success in the proposed clinical trial," said Dr. Diwan, warning, "However, it is the data from the clinical trial that will tell us if NV-387 is effective and can become an important pillar in response to this Ebola Outbreak Crisis in DRC."The clinical trial is entitled with a descriptive title: "An adaptive, multi-centre Phase IIA/IIB clinical trial of NV-387 oral gummies plus optimised supportive care in adults with Ebola virus disease (Bundibugyo or other orthoebolaviruses): a single-arm safety and dose run-in (Phase IIA) followed by a randomised, controlled, open-label efficacy evaluation with independent blinded-endpoint adjudication (Phase IIB)." Prof. Patrick de Marie Chimusa Katoto is the principal investigator leading this clinical trial, as previously announced by the Company. Om Sai is the CRO leading the Company's Phase II clinical trial of NV-387 Oral Gummies as a Treatment for Mpox in DRC, and the same CRO is also leading this Ebola clinical trial.