• Budiodarone shown in Phase 2 to reduce atrial fibrillation symptoms and long episodes of atrial fibrillation (LEAF)
• FDA gives guidance on steps necessary to gain approval and incorporate wearable AF monitoring devices into label for budiodarone
• Five granted US patents align with FDA's guidance and protect the drug and label till after 2040

LOS ALTOS, Calif., April 24, 2025 /PRNewswire/ -- XYRA LLC, a private biopharmaceutical company, is committed to developing innovative therapies for cardiac rhythm disorders with high unmet need.  With widespread use of FDA approved wearable Atrial Fibrillation (AF) monitoring devices in detecting as well as monitoring arrhythmias, it is now possible to identify subjects with long episodes of AF (LEAF) and symptoms who are at high risk of complications including stroke, heart failure and progression to permanent AF.

Having recently received FDA guidance on the approval pathway and a proposed label for budiodarone in the management of AF which will require monitoring with an FDA approved wearable device, the company is now pleased to announce the issuance of a series of new US patents that align with this guidance.  The company (XYRA) now has 5 new patents that align with our proposed US label indications (Patent No. 11,759,640) and directions for use (Patent No. 11,839,768) of budiodarone and allow a physician to identify and treat a patient with LEAF with the lowest most effective dose of the drug.  Patent No. 12,115,373 instructs a physician treating a patient with non-permanent AF on how to switch a patient from an existing antiarrhythmic drug to an effective dose of budiodarone to eliminate LEAF.  The newest patent, Patent No. 12,257,228, instructs a physician how to cardiovert a patient with persistent AF to normal sinus rhythm with oral budiodarone, before treating them chronically to prevent recurrence.

The fifth patent, (Patent No. 11,975,202) covers the use of budiodarone and monitoring with wearables to prevent progression of non-permanent to permanent AF. Progression of non-permanent to permanent AF occurs frequently and is associated with high risk of thrombo-embolic strokes, heart attacks, congestive heart failure and poor outcomes.  Preventing such progression would have immense public health benefits for the up to 7 million US subjects with non-permanent AF who are destined to progress to permanent AF if left untreated. These 5 patents complement the previously issued patent (Patent No. 9,549,912) that uses a form of budiodarone to eliminate LEAF to create a safe harbor for stroke risk reduction and they extend coverage well past 2040.

"We know the odds of having a stroke with AF goes up 5-fold in the 5 days after a LEAF greater than 5.5 hours.  So now that we can identify subjects with these events with widely available wearable AF monitoring devices, it makes sense to treat them with budiodarone and monitor the response to therapy to prevent it happening again" said Peter Milner M.D., FACC, managing member XYRA.  He added.  "These 5 new patents direct intervention with the right dose of budiodarone at the most opportune point in their disease process to improve symptoms, eliminate LEAF and modify progression of the disease.  This will reduce stroke and heart failure risk and potentially long-term delay, or prevent, progression to harmful permanent AF".

About Budiodarone: 

Budiodarone is a Phase 3 enabled potentially first-in-class mixed ion channel blocker with esterase metabolism and thus a significantly shorter half-life than amiodarone with no evidence of accumulation to date in human or animal studies.  It has been shown to treat AF by controlling symptoms, eliminating LEAF, reducing AF burden, and maintaining normal sinus rhythm.

About Atrial Fibrillation:

Atrial Fibrillation (AF) is the most common sustained arrhythmia in adults, with approximately 44 million individuals estimated to have AF worldwide. It is associated with thromboembolic risk, impairment in cardiac performance, and other morbidities. In addition to the patients with symptomatic AF, the diagnosis is often first detected after a stroke, the development of left ventricular dysfunction, or incidentally.  The management of AF has evolved over time.  Due to accumulating evidence of improved outcomes, previous management strategies that focused on simple ventricular rate control have evolved to present therapies that seek to restore and maintain sinus rhythm.  AF may be treated with anti-arrhythmic drugs (AAD), electrophysiological ablation, or some combination of the two.

About XYRA LLC: 

XYRA LLC, is a private biopharmaceutical company committed to developing innovative therapies for cardiac rhythm disorders with high unmet need.  The company's goal is to make AF management comparable to that of other common cardiac conditions like hypertension and hypercholesterolemia in which, upward dose titration of effective drugs guided by simple widely available monitoring tools used to confirm compliance and response to therapy, have consistently improved outcomes.

For information: www.xyra.us

Investor Relations Contact: Press@xyra.us

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SOURCE XYRA