Espero BioPharma is exploring its portfolio of small molecules as therapies to treat cardiac arrhythmias, with particular interest in atrial fibrillation and ventricular tachycardias and fibrillation. An arrhythmia can occur in either chamber of the heart, atrium or ventricle, and is due to abnormal electrical signals. When arrhythmias result in disabling symptoms or a device firing, efforts to prevent future arrhythmia episodes may include ablative therapy or drug therapy. Ablation is of limited success, often temporary, and is often augmented with drug therapy.
Atrial fibrillation (AF) is a disease where the atria contractions become irregular and occur at an exceedingly high rate. This disrupts the normal contraction sequence of the heart and can lead to several symptoms such as weakness, fatigue, shortness of breath and chest pains. AF episodes of long duration are currently understood to correlate with increased risk of stroke. High AF burden is associated with increased risk of hospitalization in AF patients. When arrhythmias in an ICD recipient result in disabling symptoms or a device firing, efforts to prevent future arrhythmia episodes may include ablative therapy or drug therapy. Treatments for AF include ablation therapy and drug therapy. Ablation is of limited success, often temporary, and is often augmented with drug therapy.
Implantable cardioverter defibrillators (ICDs) prolong life by treating ventricular arrhythmias when they occur. Many patients with ICDs have disabling symptoms due to sustained arrhythmias which may also lead to painful shocks from the device. These sustained life-threatening ventricular arrhythmias can be suppressed with an effective oral anti-arrhythmic drug. About two million people worldwide have an ICD, and up to 50% of these patients require additional treatment with an anti-arrhythmic agent to reduce arrhythmias and ICD firing.3,4 Existing therapies are limited in their efficacy, and some of the drugs have high rates of toxicity over time. Espero Biopharma is investigating its AADs for the prevention of life threatening ventricular arrhythmias and device firing in patients with ICDs.
Budiodarone is a clinical-stage oral drug candidate that is being investigated for its potential to treat refractory atrial fibrillation (AF), defined as those patients refractory to other anti-arrhythmic drugs or catheter ablation.
In our Phase 2 clinical trials to date,1,2budiodarone has shown a significant reduction in AF burden in a dose-related fashion and may potentially lead to a suppression of symptoms and AF recurrence. As part of the budiodarone clinical development program, we intend to demonstrate budiodarone’s potentially enhanced safety profile compared to the gold standard amiodarone, based on budiodarone’s lower risk of long term tissue accumulation and related organ toxicities. Budiodarone has a more rapid onset of action compared to amiodarone. Experience with budiodarone in initial clinical trials demonstrates that, unlike amiodarone, budiodarone can be easily dose adjusted to optimize effect.
Budiodarone is still under development and has not been shown to be safe and effective and has not been approved by any regulatory agency.