NovaCardia reported positive preliminary results from a phase III trial of KW-3902 for the treatment of acute congestive heart failure (CHF). This double-blind, randomized trial enrolled 304 subjects with CHF and renal impairment. Subjects received placebo or 10, 20 or 30 milligram doses of intravenous KW- 3902, administered daily for up to three days. All subjects received intravenous furosemide.
The primary endpoint was the proportion of subjects in the categories of treatment success, treatment failure or no change. The 30 mg dose of KW-3902 appeared to be the most efficacious, with higher rates of treatment success and lower rates of treatment failure compared to placebo.
Twenty-four hours post-treatment, self-reported marked or moderate improvement in dyspnea was reported in 66% of the KW-3902 (30 mg) group compared to 51% of the placebo group. No statistically significant differences in adverse events were reported between the groups. The 30 mg dose of KW-3902 was determined to be the optimal dose for NovaCardia’s two 600-subject phase III trials, dubbed PROTECT-1 and PROTECT-2.
Both trials are enrolling subjects in the U.S., Canada, Europe, Israel and Russia.