Arca Biopharma today announced that it had received FDA clearance to start a phase 2B/3 trial of its novel beta-blocker, Gencaro (bucindolol) for the prevention of atrial fibrillation in patients with heart failure. The GENETIC-AF trial has all the hallmarks of the modern era: the drug will only be tested in patients with a genetic variation that the company believes may predict a positive response to the drug. And the trial will be one of the first to utilize the much-discussed “adaptive” trial design, starting as a phase 2B study and then possibly expanding to a phase 3 study after an interim analysis of the trial data.
But if GENETIC-AF represents the very model of a modern drug, it also serves as a good example of the pitfalls of drug development. Because this drug has been around for a very long time and has had a very troubled history.