Several Phase 1 and two Phase 2 clinical trials have been completed for budiodarone.
Phase 2 Clinical Trials
The initial safety, tolerability and efficacy of budiodarone was evaluated in two Phase 2 studies in patients who suffer from repeated episodes of atrial fibrillation (AF).
The results of these studies suggest that budiodarone was generally well tolerated, that there were no drug specific safety concerns and that the AF burden was reduced in a dose-dependent fashion with effectiveness observed even at the lowest dose tested. The drug also produced effective suppression of AF symptoms which can be very frequent and distressing.
Additionally, the first Phase 2 study with budiodarone tracked the onset and offset of budiodarone as indicated by its blood levels in the patients. The study found that blood levels of budiodarone decreased to almost zero within one week of discontinuation of the drug. In the second randomized, double-blind, placebo-controlled Phase 2 study in 72 patients with AF and heart failure, budiodarone reduced AF burden in a dose-dependent fashion with up to 75% reduction in the highest dose group. This reduction in AF burden resulted from reductions in both the frequency and duration of AF episodes. Moreover, long episodes of AF were almost completely eliminated at the highest dose over three months.
Phase 1 Clinical Trials
These trials included single doses in 83 healthy volunteers. The drug candidate demonstrated no clinically significant adverse events within these trials. At the same time, budiodarone demonstrated a shorter half-life and did not show evidence of tissue accumulation, as reported for amiodarone. This confirmed the observations in pre-clinical studies with budiodarone. In all clinical trials, budiodarone was well-tolerated and there were no drug-related cardiovascular events or effects on surface electrocardiograms.
Budiodarone is still under development and has not been shown to be safe and effective and has not been approved by any regulatory agency.