InCarda Therapeutics Announces Positive Clinical Data Supporting Development of Inhaled Flecainide for the Treatment of Symptomatic Acute Events of Paroxysmal Atrial Fibrillation (PAF)

Flecainide administered via oral inhalation is well tolerated and elicits ECG changes suggestive of rapid drug delivery to heart

Brisbane, CA -- InCarda Therapeutics, Inc. (InCarda), a privately held biopharmaceutical company developing therapies for acute cardiovascular conditions via the inhalation route, today announced positive top-line clinical data from a Phase 1 study for its lead investigational product, InRhythm™ (inhaled flecainide), demonstrating rapid drug delivery to the systemic circulation to treat symptomatic acute episodes of 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," explained Luiz Belardinelli, MD, chief medical officer of InCarda. "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."

InRhythm™ delivers flecainide via inhalation to achieve more rapid delivery of the drug to the heart via the lungs. Delivery of flecainide via inhalation offers the potential for faster conversion to normal sinus rhythm and more rapid relief of PAF symptoms than either intravenous (IV) or oral flecainide. Flecainide is approved as an oral anti-arrhythmic drug for first-line therapy of patients with PAF. An IV formulation of flecainide is approved as first-line therapy in the EU and in selected countries for acute cardioversion of recent onset PAF.

The Phase 1 clinical study was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of flecainide delivered via inhalation and was conducted in two parts. The first part was a double-blind placebo controlled single sequential ascending dose study evaluating three doses of inhaled flecainide or placebo in 34 healthy volunteers. The second part was a two-period crossover study comparing delivery of flecainide via inhalation with delivery via IV infusion in six healthy volunteers.

The study met its endpoints of safety and tolerability; all doses of inhaled flecainide administered (estimated lung doses of 20 to 60 mg) were found to be safe and well tolerated. Inhalation of flecainide rapidly delivered the drug into systemic circulation (within one to three minutes), yielding venous plasma levels sufficient to elicit its expected electrophysiological effects, in keeping with the therapeutic activity of flecainide.

"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," stated Dr. Belardinelli.

"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," stated Grace E. Colon, Ph.D., chief executive officer and president of InCarda. "With these exciting data in hand, we are actively preparing for a Phase 2 trial."

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. InCarda is evaluating an inhaled formulation of this drug to treat symptomatic recent onset PAF. 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 (www.incardatherapeutics.com)
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 commercialization as well as 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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SOURCE InCarda Therapeutics, Inc.