NanoViricides' Revolutionary Broad-Spectrum Drug Candidate NV-387 Has Successfully Demonstrated Excellent Indications for Safety and Toxicology in a Juvenile Mouse Pups Animal Study, Paving the Way for Pediatric Use in Clinical Trials
NanoViricides reported that NV-387 showed strong safety in a juvenile Balb/c mouse pup study, with no adverse effects even at the highest dose tested -- a NOAEL of 1,230 mg/kg per dose, or 3,690 mg/kg/day over 12 days. The result paves the way for pediatric cohorts in planned Phase III registrational trials of NV-387 in Ebola and Mpox, both of which disproportionately affect children and have no approved treatments. NV-387 is already in Phase II trials for Ebola and Mpox in the DRC, and the Measles program holds FDA Orphan Drug and Rare Pediatric Disease designations with a potential Priority Review Voucher worth around $200 million if successful.
Key figures
- Drug Name
- NV-387 (Oral Gummies formulation)
- Noael mg kg day
- 3690
- Noael mg kg dose
- 1230
- Prv estimated value
- $200 million
- Dosing duration days
- 12
- Us ebola contributions
- $1.4 billion
- Cumulative exposure mg kg
- 44280
AI analysis
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