InCarda Therapeutics has announced that a Phase 1 study of InRhythm inhaled flecainide, which it is developing for the treatment of paroxysmal atrial fibrillation (PAF), met its primary and secondary endpoints, with all doses found to be safe and well tolerated and achieving effective plasma levels within 3 minutes.
In 2015, InCarda established an Australian subsidiary in preparation for the trial. The first part of the study evaluated 3 doses of inhaled flecainide vs placebo in 34 healthy volunteers; a subsequent crossover study compared inhaled flecainide to flecainide delivered via intravenous infusion in 6 healthy volunteers.
InCarda Chief Medical Officer Luiz Belardinelli said, “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. . . . 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.”
InCarda President and CEO Grace E. Colon commented, “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. With these exciting data in hand, we are actively preparing for a Phase 2 trial.”
Read the InCarda Therapeutics press release.
