The randomized, double-blind, vehicle-controlled study met its primary and secondary endpoints by demonstrating clear efficacy and safety in 482 patients.
NanoBio’s uniquely formulated lotion has reportedly resulted in faster healing of herpes labialis (cold sores), at a rate never seen before by a topical product. The company’s targeted Phase III dose demonstrated highly statistically significant clinical efficacy in Phase IIb at a magnitude comparable with or superior to what has been reported for the leading oral (systemic) anti-herpetic drugs on the market today. Additionally, NB-001 demonstrated an excellent safety profile, with no serious adverse events.
James Baker Jr., founder and chairman of NanoBio, said: “Through this trial, we have confirmed that NB-001 achieves the efficacy of leading systemic treatments without presenting safety, drug interaction or toxicity risks. Based on the data, NanoBio will move immediately to initiate plans to begin Phase III testing of NB-001 in early 2009.”