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NanoViricides Advances NV-387 Measles Treatment Toward Clinical Trials Amid Rising Global Outbreaks

Benzinga Newsdesk 1 hour ago

BiotechGeneralNews

/ NanoViricides, Inc., a publicly traded company (NYSE:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine

/ NanoViricides, Inc., a publicly traded company (NYSE:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announces that it is advancing its Measles drug development program towards clinical trials.

There have been three deaths in children due to Measles in the USA in the last ten days, one each in the states of New York, Pennsylvania, and Wisconsin i.

This condition should be unacceptable in the USA because there is already a drug against Measles that has shown effectiveness in a humanized animal model of Measles, that has gone through extensive studies including Phase I human safety study, and that is already in two Phase II clinical trials for other viral infections.

This investigational drug is NV-387, a novel, revolutionary broad-spectrum, antiviral drug developed by the Company. This drug has completed a juvenile animal model study as well. NV-387 is not yet FDA-approved or commercially available for treating Measles or any other viral disease. However, we believe the drug NV-387 now has sufficient data available to enable use under the US FDA physician-initiated investigational new drug application mechanism that is designed for use of experimental drugs for specific severe cases of disease, such as Measles. The Company continues to develop this drug in the regulatory pathways.

There were 5,164 confirmed Measles cases within the USA (excluding international visitors) as of November 5, 2026, reported in 47 jurisdictions, with 4% of these being breakthrough cases in vaccinated individuals, and remaining 96% in unvaccinated individuals. 562 (11%) of the cases were hospitalized, and 4 confirmed Measles-caused deaths were recorded. A few additional deaths in Measles cases that are under CDC review have also occurred. Majority of hospitalizations occurred in children under 5 years of age. Only 4 states, namely Arkansas, Hawaii, Mississippi, and Nevada have not reported a Measles case in 2026, according to the CDC ii. These data indicate that Measles in the USA is continuing to expand in 2026.

At this point, loss of the Measles elimination status achieved by the USA in 2000 as the very first country to achieve this status would be merely symbolic, emphasizing that Measles is a globally endemic virus with a very high potential for creating a contagion.

Vaccines, even though effective, are inadequate as the only response to such a disease as Measles, and drugs to treat Measles infections are sorely needed.

Of note, the D8 genotype of the Measles virus dominates in 2026 US cases iii whereas the Measles vaccine is based on the A genotype.

NV-387, the Company's revolutionary clinical stage broad-spectrum antiviral drug is currently in a Phase II clinical trials as an oral treatment for the Ebola Bundibugyo virus epidemic in the Democratic Republic of Congo (DRC).

The same drug, NV-387, formulated as the same oral gummies formulation is also in a Phase II clinical trial for the treatment of Mpox (Monkeypox) in DRC in a different province.

This very same drug has demonstrated remarkable antiviral activity against the Measles virus in a humanized hCD150+, IfnAR-/- mouse model of Measles virus infection and disease.

The Company has also completed a repeat-dose juvenile mouse model toxicity study in which 4-day old mouse pups were dosed with repeated doses of NV-387 oral gummies formulation to evaluate the safety and tolerability of the drug and drug product in the context of the use of the drug in children.

Under the conditions of this Juvenile Mouse Model study, the No Observed Adverse Effect Level (NOAEL) was determined to be 1,230 mg/kg per dose administered three times daily, or 3,690 mg/kg/day, or a total cumulative drug exposure of 44,280 mg/kg over the 12 day dosing period. This was actually the highest dose level tested. Therefore, a Maximum Tolerable Dose (MTD) could not be estimated iv.

Further, there was no mortality, systemic toxicity, treatment-related clinical observations, adverse effects on body weight gain, alterations in cardiovascular parameters, changes in clinical pathology, or treatment-related gross or microscopic pathological findings observed in either sex.

According to established guidelines for juvenile animal model data extrapolation, a drug evaluated for safety toxicology in 4 day mouse pups supports clinical pediatric study in infants as young as 1 month v, under an appropriate regulatory study.

Cases of Measles have been rising globally for different reasons. The measles outbreak in Bangladesh has continued to proliferate, claiming 24,073 lab-confirmed cases with 105 fatalities in lab-confirmed cases from 15 March to 10 November, 2026. During this period, a total of 207,428 patients with suspected measles were hospitalized and 1,263 persons, mostly children, have died of suspected measles, while 1,318 new suspected measles cases with at least 6 more child deaths were reported in just the last 24 hours in Bangladesh vi. The measles outbreak in Bangladesh has continued despite aggressive vaccination campaign that was undertaken since April-May 2026.

There is currently no approved drug for measles. Vaccine does not help a patient already infected with the measles virus. Vaccinating already measles-exposed persons to avoid disease spread is attempted yet measles has continued to spread in the USA.

Thus an effective treatment for Measles is an unmet medical need. NV-387 is the only drug candidate to our knowledge that has demonstrated strong in vivo activity against lethal infection with the Measles virus in a humanized animal model study, supporting its clinical regulatory development for treatment of Measles.

NanoViricides is currently developing a Phase II clinical trial protocol for evaluating NV-387 as a treatment for measles. A draft is being circulated. The Company intends to bring this protocol under the purview of the US FDA in an IND process. Therefore, this work is expected to take some time.

NV-387 has been granted a "Rare Pediatric Disease Drug" (RPDD) Designation by the US FDA Office of Orphan Products Development (OOPD).

This RPDD designation enables that a Priority Review Voucher (PRV) can be issued to the Company upon a successful Marketing Application (i.e. New Drug Application) for the use of NV-387 as a treatment for Measles, provided all of the required conditions are met. The Company can use the PRV, if granted, to reduce review times on another of its drug applications.

A PRV can be sold to another Pharma Company for accelerating their drug program as well, which provides a high value to the purchaser. PRVs have been sold for as much as $200 Million vii.

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