Canada's Cadiome announced that the lower of two doses in a Phase IIa trial of RSD1235 for atrial fibrillation hit its primary endpoint and that the drug demonstrated a good safety profile. A higher dose of the drug "trended" positive but did not achieve a statistically significant improvement in volunteers. Eight percent of patients taking a placebo reported a serious adverse event compared to 10 percent taking the lower dose of the drug and 11 percent taking 600 mg doses.
"This clinical trial has exceeded our expectations, reinforcing the signal we saw in the 300mg interim results and giving us an even greater degree of confidence in the potential for RSD1235 (oral) as a therapy for the prevention of recurrence of atrial fibrillation," said Bob Rieder, CEO of Cardiome. "In particular, we are encouraged by the strong safety data we've seen in a target patient population which includes a high proportion of older patients and patients with congestive heart failure."
- see the release on the trial