InCarda Therapeutics has announced enrolment of the first patient in the company’s pivotal phase 3 RESTORE-1 clinical trial of InRhythm (orally inhaled flecainide) in patients with newly-diagnosed atrial fibrillation (AF) or recurrent paroxysmal atrial fibrillation (PAF).
At an end-of-phase 2 (EOP2) meeting with the US Food and Drug Administration (FDA), InCarda received FDA concurrence that this single phase 3 trial would be acceptable to support the filing of a new drug application (NDA) for InRhythm for the acute conversion of recent-onset AF to sinus rhythm (SR) under medical supervision.
RESTORE-1 is a phase 3, multicentre, randomised, double-blind, placebo-controlled clinical study designed to evaluate the efficacy and safety of InRhythm compared with placebo in patients with recent-onset, symptomatic newly-diagnosed AF or recurrent PAF. The study plans to enroll approximately 400 patients to receive InRhythm (n=300) or a vehicle-matched placebo inhalation solution (n=100). The study’s primary endpoint is the proportion of patients whose AF converts to SR within 90 minutes after initiation of dosing. Safety, as well as several secondary clinical endpoints (e.g., AF-related symptoms, hospitalisations, the need for other AF-related interventions, and time to discharge), will also be assessed. Topline study results are expected in late 2023.
“We are excited to have enrolled the first patient in the RESTORE-1 study, as we believe that orally inhaled flecainide has the tremendous potential to offer AF patients a much more rapid and non-invasive treatment for restoring normal sinus rhythm,” said Mark Y Lee (MemorialCare Long Beach Medical Center, Long Beach, USA), RESTORE-1 study investigator. “Current acute treatments of AF episodes in the hospital consist of IV rhythm control medications with poor risk-benefit, IV rate control medications that can reduce symptoms but do not directly treat the AF, or electrical shock that is highly resource intensive and potentially traumatising for patients. We have seen significant patient interest in participating in the RESTORE-1 study, which underscores the demand for better acute treatments for AF conversion.”