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news.NanoBio Corporation has successfully completed its phase II study of its drug NB-001 in patients with herpes labialis and is moving ahead with plans to conduct phase III clinical trials next year.
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In the study, which enrolled 332 patients, those who received the highest dose of NB-001 (0.1%) trended to show healing one day sooner than subjects in the control group. A significant proportion of subjects on the highest dose of NB-001 had healing two or more days earlier than the control group. There were no drug-related adverse events, reports of drug-induced skin irritation or drop-outs due to adverse events.
“With nearly 150 million outbreaks of herpes in the US each year and the increasing concern for the potential of resistance to currently available drug therapies, there is a growing need to develop more effective treatments for these infections,” said Michael Nestor, CEO of NanoBio. “We believe our findings demonstrate a clinically significant benefit from the highest dose of NB-001 and, therefore, provide the basis for conducting pivotal phase III studies next year.”
NanoBio plans to present its phase II findings along with its plans for phase III studies to the FDA later this year.