HI-1640V: Preliminary Phase IIb data

Preliminary data from the double-blind, Australian Phase IIb HI-H005 trial in 287 evaluable patients with moderate to severe COPD showed that oral HI-164OV did not reduce the number of exacerbations requiring corticosteroid treatment or hospitalization, the primary endpoint, vs. placebo. In a subgroup of patients <65 years old (n=about 30%), HI-164OV did significantly reduce the number of hospitalizations associated with exacerbations by 50% and the number of hospitalization days associated with exacerbations by 65%. The subgroup analysis also showed that HI-164OV significantly increased time to first exacerbation and significantly reduced the number of corticosteroid treatments.

Previously reported data from the Phase II HI-H002 trial in 38 COPD patients showed that HI-1640V non-significantly reduced the number of episodes of acute exacerbations, defined as an increase in volume and purulence of sputum, by 16% vs. placebo (see BioCentury, May 3, 2010). The company said there appeared to be a lower incidence of H. influenzae infections during HI-H005, which may account for the reduced incidence of exacerbations across both treatment groups and explain the difference between HI-H002 and HI-H005. ...