Human anti-M2e antibody: Phase IIa data

Data from 48 evaluable healthy volunteers with laboratory-confirmed influenza A infection in a double-blind, U.K. Phase IIa influenza A viral challenge trial showed that a single dose of 40 mg/kg IV TCN-032 given 24 hours after viral inoculation missed the primary endpoint of reducing the proportion of subjects with grade >=2 influenza symptom or pyrexia from day 1-7 vs. placebo (41.2% vs. 54.2%, p=0.21). TCN-032 did meet several secondary endpoints, including significantly reducing median clinical symptom severity score by 35% from day 1 to 7 vs. placebo (25.5 vs. 39 points, p=0.047), and of reducing viral shedding from the nasal mucosa by 2.2 log10 from day 2-7 vs. placebo (p=0.095, with p>0.1 being the threshold for significance). Viral resistance analysis showed no change in the epitope recognized by TCN-032. TCN-032 was well tolerated with no serious adverse events reported. Data were presented at the Options for the Control of Influenza meeting in Cape Town. ...