NanoViricides Says Its Phase IIA Ebola Treatment Clinical Trial Of NV-387 Oral Gummies Is Progressing Well

The Phase IIA part of the clinical trial is designed to evaluate different dosage regimens of the oral gummies for the treatment of different severity levels of the Ebola Bundibugyo virus infection and disease in the current Ebola Outbreak in the Democratic Republic of Congo ("DRC").

The trial is enrolling and is expected to continue enrolling persons exhibiting different disease severity levels, in the "Dry Stage" and "Wet Stage". The clinical symptoms of the Ebola BDBV disease are complex, and possibly different from prior Ebola virus outbreaks, as explained in the footnote i.

Patients are known to come to the Ebola Treatment Centers only when they feel severely ill. Therefore, we are anticipating mostly "Wet Stage" patients, with severe vomiting and diarrhea, to be the primarily enrolled population. Some patients may not be able to take the oral gummies due to vomiting bouts and may be withdrawn; such subjects would not be considered as evaluable if enrolled.

The Phase IIA part of the trial is designed to examine the safety and tolerability of NV-387 oral gummies dosing in the Ebola patients, and the number of days that the drug is tolerated within the context of the disease, starting at 6 days of dosing, and extending by 3 day increments to a maximum of 12 days of treatment. The NV-387 treatment will be stopped when the patient's viral load has become undetectable based on qRT-PCR. Efficacy is not expected to be evaluated in a scientific, statistically significant, manner in such an adaptive treatment scenario. Therefore, and with due ethical consideration, a parallel group of no NV-387 treatment is excluded in this exploratory Phase IIA part.

Nevertheless, an efficacy signal can be seen even in this small clinical trial with up to 20 subjects, if NV-387 is highly effective. This can happen if the data of 20 subjects treated with NV-387 is found to be sufficient to statistically discriminate the NV-387 treated group from the general observations of treatment of Ebola patients in the Ebola Treatment Centers in the same area. Ebola Patients in this area have generally experienced an infection-to-fatality rate (IFR) of 67% to 75%. The IFR corrects the data for the fact that the infected person dies on an average about three weeks later, and therefore is a more accurate representation of reality than the crude Case Fatality Rate (CFR) ii.

The Company will be able to make an announcement regarding (i) whether NV-387 is found to be sufficiently safe and well tolerated to continue into Phase IIB, and, (ii) if NV-387 group is well discriminated from the general expectation of 67-75% IFR, then whether NV-387 oral gummies treatment demonstrated signs of efficacy against the Ebola Bundibugyo virus; after the Phase IIA clinical trial is completed and a report is prepared by the Principal Investigator's team for formal communication.