XYRA, a biopharmaceutical company focused on developing treatments for cardiac rhythm disorders, has received a new patent from the United States Patent and Trademark Office (USPTO) for the use of dose-adjusted budiodarone in the treatment of Atrial Fibrillation (AF). The patent (No. 12,551,706) covers a treatment approach that combines personalised dosing with patient monitoring to potentially reduce the risk of stroke and congestive heart failure.

Atrial fibrillation and heart failure frequently coexist and can worsen each other, creating significant challenges in clinical management. Loss of atrial contraction during AF can reduce cardiac output, significantly increasing the risk of complications such as heart failure, stroke and death. Studies suggest that nearly 40 percent of patients hospitalised with AF also suffer from heart failure.

Despite the high prevalence of these conditions, treatment options remain limited. Many currently approved anti-arrhythmic drugs used to treat AF can negatively affect ventricular function, which may trigger or worsen heart failure. As a result, such therapies are often unsuitable for patients with existing heart failure or those at high risk of developing it.

Budiodarone has shown promise as a potential alternative. Clinical studies indicate that the therapy can significantly reduce both the frequency and duration of AF episodes while helping restore normal sinus rhythm and atrial contraction. Importantly, the drug has demonstrated good tolerability in AF patients with heart failure and does not appear to depress ventricular function.

With the growing availability of wearable monitoring devices approved by the US Food and Drug Administration (FDA), clinicians can now more easily detect patients experiencing high atrial fibrillation burden or prolonged AF episodes. These individuals face a greater risk of stroke, heart failure and progression to permanent AF. Dose-adjusted budiodarone, used alongside continuous monitoring, could offer a personalised approach to managing these risks.

Peter Milner, MD, FACC and managing member of XYRA, noted that the rising prevalence of atrial fibrillation and heart failure underscores the urgent need for safer treatment options. He added that the company plans to evaluate monitored, dose-adjusted budiodarone in Phase III clinical trials as a potential rhythm-control therapy for AF patients, including those with heart failure or at risk of developing the condition.

Budiodarone is currently being evaluated in Phase III studies and is considered a potential first-in-class mixed ion channel blocker. Unlike amiodarone, it has a significantly shorter half-life and shows no evidence of tissue accumulation in human or animal studies. The drug works by reducing AF burden, eliminating long episodes of atrial fibrillation and maintaining normal sinus rhythm.

Atrial fibrillation is the most common sustained cardiac arrhythmia in adults, affecting an estimated 44 million people worldwide. The condition increases the risk of thromboembolic events, impaired cardiac performance and other complications. Advances in treatment strategies have shifted from simply controlling ventricular rate to actively restoring and maintaining normal heart rhythm using anti-arrhythmic drugs, catheter ablation, or a combination of therapies.

XYRA aims to advance AF management by developing therapies that can be personalised through dose adjustments and supported by widely available monitoring technologies, similar to treatment approaches used for conditions such as hypertension and high cholesterol.