XYRA Announces Successful FDA End of Phase 2 Meeting and Agreement on Endpoints for Approval of Budiodarone for the Management of Atrial Fibrillation

The Agency agrees that there is no need to perform a large long term cardiovascular (CV) outcomes study, either before or after approval. This is a testament to the improved design features introduced into a widely used and well characterized class of drugs, absence of EKG changes at therapeutics doses heretofore used and the need for monitoring with a wearable device to establish a subject on the lowest most effective dose and to discontinue if ineffective. In addition, if the drug continues to be safe and effective in the agreed AF pivotal studies above and a short-term study of ventricular tachycardia (VT) subjects with an implantable cardiac defibrillator (ICD), then approval may be possible within International Conference on Harmonization (ICH) guidance.

The Agency agrees that there is no need to perform a large long term cardiovascular (CV) outcomes study, either before or after approval. This is a testament to the improved design features introduced into a widely used and well characterized class of drugs, absence of EKG changes at therapeutics doses heretofore used and the need for monitoring with a wearable device to establish a subject on the lowest most effective dose and to discontinue if ineffective. In addition, if the drug continues to be safe and effective in the agreed AF pivotal studies above and a short-term study of ventricular tachycardia (VT) subjects with an implantable cardiac defibrillator (ICD), then approval may be possible within International Conference on Harmonization (ICH) guidance.

"Budiodarone is a potentially best-in-class mixed ion channel blocker with features that are designed to enhance safety and efficacy in the treatment of symptomatic non-permanent AF.  We wish to thank the Agency for a timely and successful series of EoP2 meetings at which we obtained clear, specific, and useful guidance on the pathway to approval.  Integrating FDA approved and validated wearable AF monitoring devices into the development will allow us to identify eligible subjects and ensure they are then established on the lowest effective approved dose." said Peter Milner M.D., FACC, managing member XYRA. "We look forward to collaborating with the Agency to demonstrate budiodarone is both safe and effective for the management of symptomatic non-permanent AF.  This is a sizable and growing population with an unmet need and includes subjects with persistent AF that can be cardioverted, and those with PAF at high risk because of LEAF that is refractory to other therapies".

About Budiodarone: 

Budiodarone is a Phase 3 enabled potentially best-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, whilst having superior efficacy due to its enhanced late sodium channel blocking properties.  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 or contact either: cflynn@xyra.us or press@xyra.us

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