The phase IIb trial will be conducted at 30 sites in the US, where 1,000 potential subjects are being recruited.
“Given the remarkable safety profile of NB-001 and the clear efficacy demonstrated in our prior trial, we are now able to perform a phase IIb study with doses that are three and five times higher then previously used,” stated Dr James Baker, NanoBio's chief science officer.
“NB-001 safely and effectively targets the herpes virus when applied to the skin, thus making it a promising topical treatment for herpes labialis. Its novel mechanism of action leaves little risk of drug resistance, which is a concern with the systemic anti-viral therapies used to treat this disease. These attributes may eventually allow NB-001 to be sold without a prescription.”
In 2005, NanoBio completed a phase II study of NB-001 for the treatment of herpes labialis. When compared to a placebo, a substantially higher proportion of subjects receiving NB-001 healed within three days or four days. Also, the time it took for sores to heal in NB-001-treated subjects was shortened by over a day.