FDA end of phase II meeting leaves InRhythm on track for phase III trials and filing in atrial fibrillation.- InCarda Therapeutics

The official EOP2 meeting minutes highlight agreement between FDA and InCarda that a single Phase III trial of 400 patients will be acceptable to support the filing of a New Drug Application (NDA) for InRhythm for the acute conversion of recent-onset paroxysmal atrial fibrillation (PAF) to sinus rhythm (SR). The company remains on track to initiate the pivotal Phase III trial of InRhythm (RESTORE1) in recent-onset PAF patients during the third quarter of 2021, with data readout expected in the second half of 2022.

The therapy is being developed initially for use in a medically supervised setting such as a hospital or emergency room and subsequently as a portable treatment that can be self-administered by patients in a non-medically supervised setting (such as the home). The Phase II program demonstrated that InRhythm can safety and rapidly convert recent onset PAF to SR, with a median time to conversion of approximately eight minutes after completing the administration of the treatment.