InCarda Therapeutics touted top-line data today from a Phase I study of its InRhythm inhaled flecainide as a treatment of symptomatic acute episodes of paroxysmal atrial fibrillation.
InRhythm delivers flecainide via inhalation to get the drug to the heart through the lungs. Flecainide is already approved as an oral anti-arrhythmic drug for patients with PAF.
“Patients with PAF experience acute episodes of heart palpitations, lightheadedness, fatigue and shortness of breath caused by fast heart rate and irregular rhythm, and are at increased risk of strokes. Many require hospital procedures such as electrical cardioversion (shock), to restore normal heart rhythm,” Dr. Luiz Belardinelli, chief medical officer, said in prepared remarks. “The clinical study results are consistent with our preclinical findings, which suggest that InRhythm could restore normal heart rate and rhythm in patients with PAF.”
The Phase I trial was designed to evaluate the safety, tolerability and pharmacokinetics/dynamics of inhaled flecainide. The 1st part of the trial assessed 3 doses of inhaled flecainide or placebo in 34 healthy volunteers. The 2nd part of the trial compared delivery of flecainide via inhalation to delivery via IV infusion in 6 healthy volunteers.
The study met its safety and tolerability endpoints. Inhaled flecainide was found to be safe and well-tolerated by the study’s participants and it was delivered to the patient’s system within 1 to 3 minutes.
“We are excited about these results and the potential for inhaled flecainide to safely restore normal heart rate and rhythm as well as relieve symptoms from episodes of PAF within minutes after inhalation without the need to go to a hospital or emergency room,” Belardinelli said.
“In the US alone, atrial fibrillation affects over five million patients and results in an annual expenditure of over $26B. Providing patients a way to treat their episodes of PAF soon after the onset of symptoms, whether at home, at work or anywhere else, should markedly improve their quality of life, make the overall management of PAF more efficient, and reduce healthcare utilization and costs,” president & CEO Grace Colon said. “With these exciting data in hand, we are actively preparing for a Phase II trial.”