This study is expected to pave the way for pediatric use of NV-387 in clinical trials in children possibly as young as 1 year old. Pediatric drugs for Ebola, Mpox, and Measles, as well as RSV - to name a few of the Company's current or contemplated clinical trial programs - are unmet medical needs. NV-387 is an extremely broad-spectrum antiviral drug that has demonstrated strong effectiveness in relevant animal models of multiple human viral infections. These include RSV, COVID, Influenza, Mpox, Smallpox, and Measles.
The Impact of the Juvenile Animal Model Study of NV-387 Treatment
NV-387 Oral Gummies formulation is currently in a Phase II clinical trial for the treatment of Ebola in the Democratic Republic of Congo (DRC). The novel Ebola Bundibugyo virus is known to disproportionately affect children i. NanoViricides anticipates being able to add a pediatric cohort in a Phase III registrational clinical trial, assuming the drug is found to be effective in the current Phase II clinical trial. If successful, NV-387 will likely be the first and only treatment for Ebola virus infection in children. There is no approved treatment nor an approved vaccine for the Ebola Bundibugyo virus.
NV-387 is also currently in another Phase II clinical trial for the treatment of Mpox in the Democratic Republic of Congo (DRC). Mpox Clade I, which is the currently most prevalent version of this virus, is known to disproportionately affect children. There is no approved treatment for Mpox. If Phase II is successful, we intend to add a pediatric cohort in the following Phase III registrational clinical trial.
NV-387 as a Treatment for Measles was granted an Orphan Drug Designation as well as a Rare Pediatric Disease Drug Designation by the US FDA. Measles primarily affects children. There is no approved treatment for Measles. The Company intends to perform a Phase II and, if successful, a Phase III clinical trial for NV-387 as a Treatment for Measles, towards a US FDA Marketing Authorization Application. If the program is successful and MAA is granted, then the Company will be eligible for a Priority Review Voucher (PRV). A PRV can fetch around $200 million if sold to another Pharma company ii, enabling substantial revenues even prior to achieving significant commercial sales.
The Juvenile Animal Model Study of NV-387 Oral Gummies Treatment and Results
Under the conditions of this 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 iii.
These numbers are indicative of extremely strong safety and will enable a wide range for dosing of NV-387 in pediatric clinical trials for the treatment of various viral diseases.
A 12 Day Repeated-Dose Safety/Tolerability, Toxicity and Toxicokinetic Study with a 14-Day Recovery Period in Juvenile Balb/c Mouse Pups, was conducted to evaluate the safety/tolerability, toxicity and toxicokinetic profile of NV-387 Oral Gummies, containing the active pharmaceutical ingredient (API) NV-387. The Juvenile Balb/c mouse pups received NV-387 Oral Gummies formulation doses three times daily for up to 12 consecutive days, followed by recovery period to assess persistence, reversibility, or delayed occurrence of any treatment-related effects.
NV-387 Oral Gummies were well tolerated at all dose levels, including the highest dose of 1,230 mg/kg per dose amounting to drug exposure of 3690 mg/kg/day, or a total cumulative drug exposure of 44,280 mg/kg over the 12 day dosing period. 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.