XYRA Announces FDA Label Guidance for Managing Atrial Fibrillation with Budiodarone and Wearable Monitoring Devices

Key points:

Wearable AF monitoring devices are extensively used in routine practice worldwide.
The FDA has agreed on the use of AF monitoring devices in clinical trials for budiodarone approval.
The FDA has also issued guidance on the steps required to incorporate wearable AF monitoring devices into a drug label.

LOS ALTOS, Calif., Oct. 16, 2024 /PRNewswire/ — XYRA LLC, a private biopharmaceutical company, is committed to developing innovative therapies for cardiac rhythm disorders with high unmet needs. With the widespread use of FDA-approved wearable Atrial Fibrillation (AF) monitoring devices for arrhythmia detection, it is now possible to identify subjects with long episodes of AF (LEAF) and symptoms; these patients are at high risk of complications including stroke, heart failure and progression to permanent AF.

Phase 2 clinical data substantiates that XYRA’s drug candidate, budiodarone, delivers significant reductions in symptoms, as well as the frequency and duration of AF episodes, among subjects with non-permanent AF which compare favorably to the results obtained with AF-ablation in a recent study. Upon reaching an agreement with the FDA regarding clinical trial endpoints and potential approval pathway for multiple active doses of budiodarone in the management of non-permanent AF, XYRA sought and received guidance from the FDA on a prospective label for budiodarone use post-approval. The FDA’s guidance specified indications and directions for use to control AF symptoms and achieve a safe harbor for stroke risk reduction by elimination of LEAF greater than 5 hours. Both endpoints were demonstrated in Phase 2 trials of budiodarone. The FDA indicated that the label likely would include directions for maintaining patients on the appropriate therapeutic dose of budiodarone. In addition, XYRA’s unique approach incorporates AF monitoring and enables the identification of patients who do not respond to the maximum therapeutic dose. This early detection allows for the timely discontinuation of budiodarone in non-responsive patients, thereby preventing unnecessary exposure to a non-therapeutic drug. The FDA indicated that a label for budiodarone including an AF monitoring device requirement is possible if upcoming clinical trials demonstrate that AF montoring systems are able to generate data that could be used to successfully adjust the dosage of budiodarone during treatment.

“Xyra assured the Agency that if the proposed label includes a requirement for intermittent AF monitoring with approved wearable devices, only eligible subjects will be prescribed Budiodarone. These patients will be established on the lowest, most effective dose to ensure that symptoms and LEAF are controlled and if there is an inadequate response to the highest recommended dose, treatment will be discontinued,” said Peter Milner, M.D., FACC, managing member of XYRA. He added, “Budiodarone, with its dose-proportional pharmacology and intermediate half-life offers an ideal opportunity to integrate state-of-the-art digital AF monitoring technology into routine practice, enabling us to identify the patients with AF who benefit most from the drug. 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 it is possible to identify these patients with wearable AF monitoring devices in real time, it makes sense to treat them with budiodarone and monitor the response to therapy to prevent long episodes of AF from happening again.”

The currently FDA-approved wearable devices available for use in AF and potentially with budiodarone to determine eligibility and response to therapy include patch devices such as Philips’ E-patch^® or MCOT^®, iRhythm’s Zio^® Patch, and wrist wearables like the Zio^® ZEUS and Apple Watch^®. This list is expected to rapidly expand thanks to the phenomenal innovation occurring in the digital healthcare sector such that wearable cardiac monitoring is projected by some to be a $4B business globally by 2028.

About Budiodarone:

Budiodarone, a Phase 3 enabled, potentially best-in-class mixed ion channel blocker, features esterase metabolism and thus a significantly shorter half-life than amiodarone, with no evidence of accumulation in human or animal studies to date. Its superior efficacy is attributed to its enhanced late sodium channel blocking properties. Budiodarone has demonstrated the ability 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 heart arrhythmia in adults, affecting approximately 44 million individuals worldwide. It is associated with thromboembolic risk, impaired cardiac performance, and other morbidities. Besides patients with symptomatic AF, the condition is often first detected after a stroke, the development of left ventricular dysfunction, or incidentally via patient examination. The management of AF has evolved over time. Due to accumulating evidence of improved outcomes, previous strategies focusing on simple ventricular rate control have shifted to current therapies that seek to restore and maintain sinus rhythm. AF may be treated with anti-arrhythmic drugs (AAD), electrophysiological ablation, or a combination of both.

About XYRA LLC:

XYRA LLC is a private biopharmaceutical company committed to developing innovative therapies for cardiac rhythm disorders with high unmet needs. The company’s goal is to make AF management comparable to that of other common cardiac conditions, such as hypertension and hypercholesterolemia. In these conditions, upward dose titration of effective drugs, guided by simple and widely available monitoring tools to confirm compliance and response to therapy, has consistently improved outcomes.

For information: www.xyra.us

Investor Relations Contact: [email protected]

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SOURCE XYRA