NanoViricides Reports Juvenile-Mouse Safety Findings for NV-387 Antiviral Candidate
NanoViricides said its NV-387 Oral Gummies formulation was well tolerated in a juvenile mouse study, supporting plans to consider pediatric cohorts in future clinical trials subject to further results.
NanoViricides, Inc. (NYSE American: NNVC) has reported safety, tolerability and toxicology findings from a juvenile mouse study of its NV-387 Oral Gummies antiviral candidate. The company said the results may support the inclusion of children, potentially as young as 1 year old, in future clinical trials, although NV-387 remains subject to further clinical and regulatory evaluation.
Juvenile Balb/c mouse pups received NV-387 three times daily for up to 12 consecutive days. The protocol then included a 14-Day Recovery Period intended to assess whether treatment-related effects persisted, were reversible or appeared later.
NanoViricides reported that the formulation was tolerated at every dose tested. The highest level was 1,230 mg/kg per dose administered three times daily, equivalent to 3,690 mg/kg/day and a total cumulative exposure of 44,280 mg/kg over the 12 day dosing period.
The company said the study recorded no mortality, systemic toxicity, treatment-related clinical observations, adverse effects on body weight gain, cardiovascular parameter changes, clinical pathology changes, or treatment-related gross or microscopic pathological findings in either sex.
The No Observed Adverse Effect Level was identified as 1,230 mg/kg per dose administered three times daily. Because this was the highest dose tested, NanoViricides said a Maximum Tolerable Dose could not be estimated.
These findings come from an animal study and do not establish safety or effectiveness in humans. The company’s use of terms such as safety and effectiveness refers to research findings and does not represent an evaluation by the US FDA.
NV-387 Oral Gummies is currently being evaluated in a Phase II clinical trial for Ebola in the Democratic Republic of Congo and in another Phase II clinical trial for Mpox in the Democratic Republic of Congo.
NanoViricides said it anticipates adding a pediatric cohort to a Phase III registrational Ebola trial if NV-387 is found to be effective in the current Phase II study. For Mpox, the company intends to add a pediatric cohort in the subsequent Phase III registrational trial if the Phase II study is successful.
The company identified Ebola, Mpox and Measles, along with RSV, among its current or contemplated pediatric programs. It said the Ebola Bundibugyo virus and Mpox Clade I disproportionately affect children, while Measles primarily affects children. The company also said there is no approved treatment for the Ebola Bundibugyo virus or Mpox, and no approved treatment for Measles.
NanoViricides said NV-387 has received Orphan Drug Designation and Rare Pediatric Disease Drug Designation from the US FDA for treatment of Measles. The company intends to conduct a Phase II trial and, if successful, a Phase III trial aimed at a US FDA Marketing Authorization Application.
If the Measles programme is successful and a Marketing Authorization Application is granted, NanoViricides said it would be eligible for a Priority Review Voucher. The company cited an estimate that such a voucher can fetch around $200 million if sold to another Pharma company, but any outcome depends on the stated clinical and regulatory conditions.
NanoViricides said management is continuing to seek non-dilutive funding for NV-387. It also plans to pursue equity-based financing through different routes when considered opportune, including an “At-the-Market” facility with an investment brokerage house for issuing and selling common shares directly to investors.
The company said its Annual Report on Form 10-K for the fiscal year ending June 30, 2026 was filed with the Securities and Exchange Commission on Monday, September 28, 2026. The audit report included an explanatory paragraph stating that the audit opinion expressed substantial doubt about NanoViricides’ ability to continue as a going concern.
NanoViricides also cautioned that pharmaceutical development is lengthy and requires substantial capital. It said there is no assurance that its candidates will demonstrate sufficient effectiveness and safety for human clinical development, or that preclinical and laboratory findings will lead to successful clinical trials or an approved pharmaceutical product. The company identified additional risks including regulatory delays, changes in government funding and budgets, dependence on external collaborators and consultants, obtaining regulatory approvals, commercialisation and market acceptance.
NanoViricides reported that NV-387 Oral Gummies were well tolerated in a juvenile Balb/c mouse study.
The highest tested level was 1,230 mg/kg per dose administered three times daily, with 3,690 mg/kg/day and 44,280 mg/kg over the 12 day dosing period.
The company said pediatric cohorts could be considered in future Ebola and Mpox Phase III trials, subject to successful Phase II results.
NV-387 has received Orphan Drug Designation and Rare Pediatric Disease Drug Designation for Measles, according to NanoViricides.
The company disclosed substantial doubt about its ability to continue as a going concern and said it is seeking non-dilutive and equity-based financing.
NanoViricides, Inc. announced that its NV-387 broad-spectrum antiviral had demonstrated safety, tolerability and toxicological parameters in a juvenile mouse pups study. The company said the results are expected to support possible paediatric use of NV-387 in clinical trials, potentially in children as young as 1 year old.
NanoViricides, Inc. said NV-387 Oral Gummies were well tolerated at all tested dose levels, including the highest dose. The study reported 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 in either sex.
The highest dose tested was 1,230 mg/kg per dose administered three times daily, amounting to 3,690 mg/kg/day and a total cumulative drug exposure of 44,280 mg/kg over the 12 day dosing period. NanoViricides, Inc. said the Maximum Tolerable Dose could not be estimated because the highest dose level tested did not produce the relevant findings.
The study was a 12 Day Repeated-Dose Safety/Tolerability, Toxicity and Toxicokinetic Study with a 14-Day Recovery Period in Juvenile Balb/c Mouse Pups. The pups received NV-387 Oral Gummies three times daily for up to 12 consecutive days, followed by a recovery period to assess persistence, reversibility or delayed occurrence of treatment-related effects.
NanoViricides, Inc. identified Ebola, Mpox and Measles, as well as RSV, among its current or contemplated paediatric clinical trial programmes for NV-387. The company said these areas represent unmet medical needs and that the relevant diseases disproportionately or primarily affect children.
NanoViricides, Inc. said NV-387 Oral Gummies are currently in a Phase II clinical trial for Ebola in the Democratic Republic of Congo and in another Phase II clinical trial for Mpox in the Democratic Republic of Congo. The company said the potential addition of paediatric cohorts depends on successful Phase II results and subsequent Phase III trials.
NanoViricides, Inc. anticipates that it could add a paediatric cohort to a Phase III registrational Ebola trial if NV-387 is found to be effective in the current Phase II trial. For Mpox, the company intends to add a paediatric cohort in the following Phase III registrational trial if Phase II is successful.
NanoViricides, Inc. said NV-387 as a treatment for Measles has received Orphan Drug Designation and Rare Pediatric Disease Drug Designation from the US FDA. The company intends to conduct a Phase II trial and, if successful, a Phase III trial towards a US FDA Marketing Authorization Application.
NanoViricides, Inc. said that if the Measles programme is successful and a Marketing Authorization Application is granted, the company would be eligible for a Priority Review Voucher. The company cited an estimate that a Priority Review Voucher can fetch around $200 million if sold to another Pharma company, but this is dependent on the stated programme and regulatory outcomes.
NanoViricides, Inc. said management is continuing to seek non-dilutive funding for NV-387 and plans to continue financing the company through different equity-based funding routes when opportune. The company also has an "At-the-Market" facility with an investment brokerage house for issuing and selling common shares directly to investors.
NanoViricides, Inc. said its Annual Report on Form 10-K for the fiscal year ending June 30, 2026, filed with the Securities and Exchange Commission on Monday, September 28, 2026, included an audit report with an explanatory paragraph stating that the audit opinion expressed substantial doubt about the company's ability to continue as a going concern.
NanoViricides, Inc. identifies itself as publicly traded on the NYSE American under "NYSE American: NNVC". The company also describes itself as listed on "NYSE-American, stock symbol NNVC".
NanoViricides, Inc. is a clinical stage company developing broad-spectrum antiviral drug candidates based on nanomedicine technology. Its lead candidate is NV-387, which the company plans to develop for RSV, COVID, Long COVID, Influenza and other respiratory viral infections, as well as MPOX/Smallpox infections; its other advanced candidate is NV-HHV-1 for Shingles.
NanoViricides, Inc. said pharmaceutical development is extremely lengthy and requires substantial capital, and that there can be no assurance that its candidates will show sufficient effectiveness and safety for human clinical development. The company also identified risks including regulatory delays, changes in government funding and budgets, dependence on external collaborators and consultants, obtaining regulatory approvals, successful commercialisation and market acceptance, while noting that preclinical or laboratory results may not lead to successful clinical trials or a successful pharmaceutical product.