budiodarone (ATI-2042) / Espero BioPharma - LARVOL DELTA

XYRA Announces First Patient Dosed in Europe in the Phase 2/3 HARBOR-AF Study of Budiodarone in Paroxysmal and Persistent Atrial Fibrillation (GlobeNewswire) - "HARBOR-AF study is starting as a 100 subject Phase 2 feasibility study in EU and will extend in 2027 to US sites as one of three Phase 3 pivotal registration studies the FDA requires for approval....HARBOR-AF is a global, multicenter, open-label, dose-escalation Phase 2/3 study of budiodarone in approximately 600 subjects with highly symptomatic paroxysmal and persistent AF who have failed rhythm control with antiarrhythmic drugs or AF catheter ablation, or who have failed rate control."

Trial status • Atrial Fibrillation

Harbor-AF: Dose Escalation Study to Assess Safety, Tolerability, and Efficacy of Budiodarone Treatment With Non-permanent Atrial Fibrillation (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Xyra, LLC

New P2 trial • Atrial Fibrillation • Cardiovascular

CLN-209: A Multicenter, Open-Label, Dose Escalation Study of the Safety,nTolerability, and Efficacy of Budiodarone for the Treatment ofnSubjects with Non-permanent Atrial Fibrillation (clinicaltrialsregister.eu) - P2/3 | N=100 | Not yet recruiting | Sponsor: Xyra LLC

New P2/3 trial • Atrial Fibrillation • Cardiovascular

HARBOR-AF: a multicentre, open-label, dose escalation study of the efficacy, safety, and tolerability of budiodarone for the treatment of subjects with paroxysmal atrial fibrillation (ESC-WCC 2025) - "Conclusion HARBOR-AF is poised to set a new standard of care for non-permanent AF by utilising real-time wearable device monitoring for precise, individualised dose titration. This landmark trial aims not only to control AF symptoms and reduce LEAF but also to potentially modify disease progression, heralding a modern approach to AF management."

Clinical • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure

XYRA Announces the Issuance of a Fifth New US Patent in a Series of Patents Which Protect the Use of Budiodarone in the Management of Atrial Fibrillation till after 2040 (PRNewswire) - "Five granted US patents align with FDA's guidance and protect the drug and label till after 2040....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."

Patent • Atrial Fibrillation

A new paradigm for the management of atrial fibrillation using budiodarone and wearable devices (ESC 2023) - No abstract available

Atrial Fibrillation • Cardiovascular