InCarda Therapeutics Announces Enrollment of First U.S. Patient in Phase 2 INSTANT Trial of InRhythm™ for Treatment of Atrial Fibrillation

Ongoing Trial to Evaluate Optimal Dose Selected from Dose-Ranging Stage of the INSTANT Study for Rapid Conversion of Atrial Fibrillation to Normal Sinus Rhythm

InCarda Therapeutics, Inc., a privately-held biopharmaceutical company developing first-of-their-kind inhaled therapies for cardiovascular diseases, announced dosing of the first U.S. patient in the company’s multinational INSTANT Phase 2 clinical trial of InRhythm (flecainide for inhalation) in patients with recent-onset paroxysmal atrial fibrillation (PAF). The trial is currently being conducted at centers in the U.S. and Europe to evaluate the optimal dose (120 mg) of InRhythm that was selected based on the positive results from the open-label, dose-ranging stage of the INSTANT study.

The results from the dose-ranging stage of the trial were recently presented at the American Heart Association’s (AHA) Scientific Sessions 2020. InCarda Therapeutics in collaboration with clinical investigators reported that oral inhaled flecainide can safely and rapidly convert recent-onset PAF to normal sinus rhythm (NSR). These data provided the first proof of concept for inhaled flecainide as a potentially safe and effective therapeutic option for rapidly converting PAF to NSR.

The second stage of the INSTANT trial was initiated in October 2020 at centers in the Netherlands and Belgium, and was expanded to the U.S. with MemorialCare Long Beach Medical Center as the first U.S. site. The company plans to initiate a companion Phase 2 trial during the first half of 2021 in which patients who have already undergone a safe cardioversion with InRhythm will be trained to self-administer InRhythm under medical supervision when another (“recurrent”) episode of PAF occurs.

“Atrial fibrillation is the most common heart rhythm disorder in the U.S. Left untreated, patients in AF experience disabling symptoms, are at greater risk for stroke, and increase utilization of hospital resources. At present, options for rapid conversion of AF into a normal rhythm are limited to oral or intravenous medications and electrical cardioversion,” said Mark Y. Lee, MD, FACC, and the principal investigator of the INSTANT trial at MemorialCare Long Beach Medical Center. Flecainide delivered via oral inhalation can be easily administered to rapidly convert AF into sinus rhythm. If the clinical trial is successful, patients in AF may one day have access to a non-invasive option for the rapid restoration of normal rhythm, and may ultimately be able to use it at home when shown to be safe.”

Luiz Belardinelli, MD, chief medical officer of InCarda Therapeutics, commented: “InCarda is testing the safety, tolerability and efficacy of administering flecainide via oral inhalation to restore normal sinus rhythm in patients with symptomatic episodes of recent onset of AF. While until now the clinical investigation of this product has been conducted in Europe, development plans have always included testing at U.S. hospital sites. Thus, we are delighted to announce that the first U.S. patient has been successfully enrolled in the INSTANT trial, and grateful to Dr. Mark Y. Lee and his team for helping us investigate this novel, non-invasive approach to deliver flecainide safely and rapidly restore normal sinus rhythm.”

About MemorialCare Long Beach Medical Center

MemorialCare Long Beach Medical Center has been providing the community with compassionate, quality health care for more than 100 years. While leading in specialized care, research and education, Long Beach Medical Center has an outstanding record of innovation and medical advances, along with numerous accolades. With leading centers for cancer, heart, rehabilitation, orthopedics, neurology and trauma, physicians and surrounding hospitals continually refer to its programs. For more information, visit memorialcare.org/LongBeach.

About Atrial Fibrillation (AF)

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia (abnormal heart rhythm) and is characterized by rapid and irregular heartbeats often resulting in palpitations and other symptoms that can be debilitating. A chronic, progressive condition, AF is estimated to affect six million people in the U.S., with that number expected to double by 2050.1 This expected increase is partially due to the correlation between AF prevalence and an aging population, with approximately 9% of those aged 65 and older affected by the condition.1 AF is associated with significant morbidity and a substantial reduction in quality of life, with the condition potentially resulting in exercise intolerance, congestive heart failure, tachycardia-induced cardiomyopathy and stroke. The annual cost of AF to the U.S. healthcare system is estimated at more than $26 billion.1

Paroxysmal AF (PAF) is a type of AF in which episodes occur intermittently and resolve spontaneously in fewer than seven days. Approximately 25% of PAF patients progress to the permanent form of AF within five years.2 Common symptoms of PAF can include racing heartbeat, chest pain or pressure, a fluttering feeling in the chest, weakness, fatigue, dizziness, sweating and lightheadedness. Current treatments for patients with PAF rely upon either chronic administration of oral antiarrhythmic drugs or acute hospital-based procedures such as intravenous drug administration and electrical cardioversion, neither of which fully address the unmet need of patients for a rapid-acting treatment that can be administered whenever an episode of PAF occurs. There are currently no approved treatments that can be patient self-administered whenever an episode of PAF occurs.

About InRhythm™

InRhythm (flecainide for inhalation) is a novel inhaled therapeutic candidate designed to rapidly deliver flecainide, a well-established antiarrhythmic agent, to the heart via the lungs, to restore normal sinus rhythm (NSR) and relieve the patient’s symptoms following the onset of an episode of PAF. InRhythm is intended to address the unmet need for a non-invasive, rapid-acting treatment that can be administered in a medically supervised setting (initial indication) and, ultimately, self-administered by patients anywhere they happen to be, whenever they experience an episode of PAF. Phase 1 clinical results in healthy volunteers demonstrated that InRhythm rapidly and safely delivered flecainide resulting in ECG changes consistent with the potential to restore NSR in patients with PAF. InCarda is currently conducting the INSTANT Phase 2 trial of InRhythm in patients with recent-onset PAF. InRhythm represents a first-in-class, multi-billion dollar global opportunity to address a significant unmet medical need.

About InCarda Therapeutics

InCarda Therapeutics, Inc. is a privately-held, clinical-stage biopharmaceutical company developing first-of-their-kind inhaled therapies for acute cardiovascular diseases and conditions. The company is leveraging the ability of inhaled therapy to deliver medicine in the “first pass” to cardiac tissue, presenting a small, but effective dose of drug directly to affected regions of the heart. This permits rapid-onset, lower off-target tissue exposure of the drug, lower exposure to cardiac tissue and, more importantly, has the potential to be patient self-administered in a non-medical setting (eg, home). InCarda employs a de-risked approach by using approved drugs with a long history of efficacy and safety as candidates for the new dosing paradigm via inhalation. The company’s lead development product, InRhythm, is in Phase 2 development to treat acute episodes of PAF, a prevalent atrial arrhythmia. For more information, please visit: www.incardatherapeutics.com.

LinkedIn: https://www.linkedin.com/company/incarda-therapeutics/

Twitter: @InCardaThera

References

1 J Am Coll Cardiol. 2014 Dec 2;64(21):2305-2307.

2 Am Heart J. 2005 Mar;149(3):489-496.