Phase 2a & 2b Clinical Trials:
NB-00X demonstrated clear efficacy and safety in randomized, double-blind, vehicle-controlled Phase 2a and Phase 2b studies involving over 800 subjects with recurrent herpes labialis. The company’s targeted Phase 3 dose demonstrated highly statistically significant efficacy in the Phase 2b trial at a magnitude comparable or superior to what has been reported for the leading systemic products on the market today.
The Phase 2b trial was a blinded, randomized, placebo-controlled study at 30 sites in the United States, where almost 900 patients were recruited to treat 482 subjects with herpes recurrences.
Human and animal studies show that NB-00X is well tolerated and without safety issues, adverse events or skin irritation concerns. Pharmacokinetic studies show no systemic absorption, a factor that enhances the safety profile. |
