InCarda Presents Phase 2 Data for InRhythm (Orally Inhaled Flecainide) at the 2022 Atrial Fibrillation Symposium in New York
Phase 2 INSTANT study results demonstrate rapid restoration of normal heart rhythm with a predictable and favorable safety profile for orally inhaled flecainide.
San Francisco, California, January 15, 2022 – InCarda Therapeutics, Inc. (InCarda) announced that a poster entitled “The Safety of Pharmacological Cardioversion of Recent onset Atrial Fibrillation with Orally Inhaled Flecainide” was presented at the 2022 Atrial Fibrillation Symposium in New York. The analysis presented in this poster specifically examined the safety and tolerability of 120 mg of orally inhaled flecainide (FlecIH-103) and showed that:
- Adverse cardiovascular events (CVEs) that have been associated with oral and/or IV forms of flecainide were uncommon with orally inhaled flecainide.
- Only two CVEs were classified as serious (as per FDA definition); neither event required any additional treatment, and both resolved without sequelae.
- The optimal 120 mg dose identified in Phase 2 that InCarda plans to study in their Phase 3 program has a conversion rate of close to 50% which is achieved rapidly, within 7 minutes from end of inhalation on average.
From this analysis, the authors concluded that the risk-benefit of orally inhaled flecainide for the acute cardioversion of recent AF is highly favorable and may provide a safe, effective, and more convenient approach compared to either electrical cardioversion or pharmacological cardioversion with IV antiarrhythmic drugs.