InCarda Therapeutics has announced the initiation of the Phase 3 RESTORE-1 trial of its InRhythm flecainide inhalation solution in patients with new or recurrent atrial fibrillation. According to InCarda, the FDA has agreed that the RESTORE-1 trial alone will be sufficient to support an NDA for the flecainide inhalation solution for use under medical supervision to convert atrial fibrillation to sinus rhythm soon after onset.
The company also noted that it has published Phase 2 results for InRhythm in the journal Circulation: Arrhythmia and Electrophysiology. The Phase 2 trial was initiated in November 2018. That study was completed recently and demonstrated a median time of <15 minutes post initiation of dosing for conversion to sinus rhythm, InCarda said.
The RESTORE-1 study is expected to enroll approximately 400 patients who will get up to 120 mg of InRhythm or a placebo inhalation solution. The primary endpoint is the proportion of patients converted to sinus rhythm at 90 minutes post initial dose. The company said that it expects topline results to be available in late 2023.
InCarda President and CEO Grace Colón commented, “The initiation of this groundbreaking pivotal Phase 3 trial represents an important milestone for both InCarda and the large and underserved AF patient community, demonstrating InCarda’s success leveraging our significant combined expertise in cardiovascular disease and inhalation technology. We believe that InRhythm has the therapeutic profile to substantially move the needle for AF patients, potentially offering them a first-of-its-kind inhaled treatment that can safely and rapidly convert recent-onset AF episodes to sinus rhythm. We look forward to confirming the best-in-class efficacy and safety results from our Phase 2 program.”
Chief Medical Officer Luiz Belardinelli added, “Advancing the development of InRhythm into this pivotal Phase 3 study represents a major step towards demonstrating that episodes of recent onset AF can be safely and rapidly terminated via pulmonary delivery of anti-arrhythmic drugs such as flecainide. The results of the Phase 2 INSTANT study give us confidence that the Phase 3 trial will demonstrate a favorable benefit-risk profile for InRhythm. In addition to rapid conversion and symptom relief, we plan to demonstrate a reduction in the time and expense required to treat patients with AF in-hospital, including rapid hospital discharge and the avoidance of electrical cardioversion and hospitalization. We are very appreciative for the support and dedication of our clinical trial investigators and advisors, and give thanks to the many healthy volunteers and patients with AF who have participated in our trials to date.”
Read the InCarda Therapeutics press release.
