InCarda Therapeutics Announces Publication of Phase 2 Data Demonstrating Inhaled Flecainide for Conversion of Atrial Fibrillation to Sinus Rhythm Is Safe and Effective

The original article titled “Open-Label, Multicenter Study of Flecainide Acetate Oral Inhalation Solution for Acute Conversion of Recent-Onset, Symptomatic Atrial Fibrillation to Sinus Rhythm” published in the peer-reviewed journal, Circulation: Arrhythmia and Electrophysiology

San Francisco, California, March 15, 2022 – InCarda Therapeutics, Inc. (InCarda) announces that data from its Phase 2 INSTANT study have been published in Circulation: Arrhythmia and Electrophysiology. The publication was also selected as the “Editors Pick” denoting its potential importance in advancing cardiology care. In addition, Circulation: Arrhythmia and Electrophysiology has one of the highest impact factors, a measure of influence and importance for scientific journals, among cardiac electrophysiology journals.

The published data showed that for the first time, a single dose of inhaled flecainide can rapidly convert recent-onset (≤ 48 hours), symptomatic episodes of paroxysmal atrial fibrillation (PAF) to sinus rhythm. Cardiac adverse events were uncommon, none required treatment, and all resolved without sequelae. This dose-ranging study also identified the optimal dose (120mg), which InCarda plans to study in their Phase 3 program.

“We know flecainide is effective in restoring sinus rhythm in patients with PAF. However, IV flecainide is not available in the United States, and cardioversion with oral flecainide can take hours. Delivering flecainide via oral inhalation is a promising new option for patients with PAF, offering the potential for safe and rapid pharmacological cardioversion that may lead to shorter ER visits and reduced hospitalizations.” said Luiz Belardinelli, MD, chief medical officer of InCarda. “We are excited to initiate our Phase 3 program and bring inhaled flecainide one step closer to helping patients with PAF take control of their cardiac health.”


Key Findings of the Phase 2 INSTANT Study

  • Conversion rates increase with dose
  • The 120mg dose achieved a conversion rate of 48% within 90 minutes of the end of inhalation
  • Median time to conversion was 8 minutes from end of inhalation
  • Adverse events were typically mild and transient


InCarda’s Lead Product for PAF

Paroxysmal atrial fibrillation (PAF), the most common type of cardiac arrhythmia (abnormal heart rhythm) is characterized by rapid and irregular heartbeats that often lead to palpitations and other disabling symptoms (e.g., fatigue). Orally administered flecainide is a commonly prescribed antiarrhythmic drug indicated for suppression of recurrent episodes. InCarda is evaluating an inhaled formulation of this drug to acutely treat symptomatic recent onset AF. Inhaled delivery through the lung and pulmonary vein directly to the heart offers the potential for faster conversion of PAF to sinus rhythm with rapid relief of symptoms associated with PAF, both in and out-of hospital, along with enhanced safety.


About InCarda

InCarda Therapeutics, located in the San Francisco Bay Area with operations in Australia, is focused on transforming cardiovascular disease treatment through pulmonary drug delivery of established drugs. The company is led by a team with extensive experience in drug development and inhalation delivery. The lead product under development is a clinical-stage inhaled therapy intended to treat recent onset AF in patients with paroxysmal atrial fibrillation (PAF). InCarda is also working on additional research concepts that leverage the same platform technology to target the heart for acute cardiac conditions.

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