Cardiome Announces Positive Interim Phase 2b Results for Oral Vernakalant
Cardiome Pharma Corp. announced positive interim clinical results from its 90-day Phase 2b study of vernakalant (oral). The interim analysis demonstrated statistically significant efficacy for the patient group receiving 500mg b.i.d. of vernakalant (oral) as compared to placebo. The safety data from the interim analysis also suggests that vernakalant (oral) was well-tolerated in the atrial fibrillation population studied during the dosing period under analysis.
A Kaplan-Meier analysis of the 446 patients included in the interim dataset demonstrated a significant efficacy benefit for the 500mg dosing group as compared to placebo (two-sided, p(less than)0.05). Median time to recurrence of atrial fibrillation was greater than 90 days for the 500mg dosing group, compared to 39 days for the placebo group. 52% of patients in the 500mg dosing group (n=110) completed the study in normal heart rhythm compared to 39% of patients receiving placebo (n=118). The interim efficacy analysis for the 150mg (n=110) and 300mg (n=108) dosing groups had not achieved statistical significance at the interim timepoint.
"This larger-scale, longer-term study of vernakalant (oral) was designed to find the appropriate dose to take into Phase 3, and to confirm our assumptions regarding safety," said Dr. Charles Fisher, Executive Vice President and Chief Medical Officer of Cardiome. "While the study is ongoing and we must await the final data before drawing conclusions, these statistically significant and clinically significant efficacy results as well as the attractive safety profile observed in this interim analysis strongly support our belief in the exciting potential of vernakalant (oral) as a therapy for atrial fibrillation."
The safety data for all dosing groups suggests that vernakalant (oral) was well-tolerated within the interim safety population (n=537), which includes patients randomized who did not enter the maintenance phase of the study. During the dosing period under analysis, there was no difference in the incidence of serious adverse events between treatment groups. Potentially drug-related serious adverse events occurred in 1% of placebo patients, 2% of patients in the 150mg dosing group, 0% of patients in the 300mg dosing group and 1% of patients in the 500mg dosing group. There were no cases of drug-related "Torsades de Pointes", a well-characterized arrhythmia which is an occasional side effect of some current anti-arrhythmic drugs. There were 2 deaths during this period, both unrelated to vernakalant (oral), comprising a patient in the 150mg dosing group who died of cervical cancer at day 79, and a patient in the placebo group who died at day 86 after suffering an ischemic stroke.
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