Single Pivotal Phase 3 Trial in Atrial Fibrillation Acceptable to Support Filing of New Drug Application
Company on Track to Initiate Phase 3 RESTORE1 Study in Q3 2021 with Data Expected 2H 2022
SAN FRANCISCO, June 23, 2021 (GLOBE NEWSWIRE) — InCarda Therapeutics, Inc. (“InCarda”), a privately-held biopharmaceutical company developing first-in-class inhaled therapies for cardiovascular diseases, today announced that it has successfully completed an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for InRhythm™ (flecainide for inhalation) for the treatment of atrial fibrillation. The official EOP2 meeting minutes highlight agreement between FDA and InCarda that a single Phase 3 trial of 400 patients will be acceptable to support the filing of a New Drug Application (NDA) for InRhythm for the acute conversion of recent-onset paroxysmal atrial fibrillation (PAF) to sinus rhythm (SR). The company remains on track to initiate the pivotal Phase 3 trial of InRhythm (RESTORE1) in recent-onset PAF patients during the third quarter of 2021, with data readout expected in the second half of 2022.
InRhythm is a novel, orally inhaled therapeutic candidate designed to rapidly deliver flecainide, a well-established antiarrhythmic agent, to the heart via the lungs to restore SR in patients with recent-onset PAF and to relieve their associated symptoms. The therapy is being developed initially for use in a medically supervised setting such as a hospital or emergency room and subsequently as a portable treatment that can be self-administered by patients in a non-medically supervised setting (such as the home). The Phase 2 program demonstrated that InRhythm can safety and rapidly convert recent onset PAF to SR, with a median time to conversion of approximately eight minutes after completing the administration of the treatment.
“Following the successful completion of our End-of-Phase 2 meeting with FDA for InRhythm, we are one significant step closer to achieving our goal of developing a first-of-its-kind inhaled treatment capable of addressing the critical unmet treatment needs of patients with atrial fibrillation. As the data from our Phase 2 clinical trial demonstrate, InRhythm has the potential to safely and rapidly convert recent-onset episodes of atrial fibrillation to sinus rhythm, offering key advantages over the limited treatment options currently available,” said Grace Colón, Ph.D., president and chief executive officer of InCarda. “We look forward to initiating our pivotal Phase 3 trial for InRhythm and work to collect the final data needed to support an NDA filing for this program.”
The EOP2 meeting scope included all aspects of the development plan for InRhythm, including preclinical and clinical data, and data from the recently completed positive INSTANT Phase 2 study showing that oral inhaled flecainide can safely and rapidly convert recent-onset PAF to normal SR. As documented in the EOP2 meeting minutes, InCarda and FDA have agreed on the key details for the RESTORE1 pivotal Phase 3 study, including the efficacy and safety endpoints, number and type of patients to be studied and enrollment criteria.
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 20501. 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 condition1. 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 billion1.
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 years2. 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 sinus rhythm (SR) 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. The INSTANT Phase 2 trial of InRhythm in patients with recent-onset PAF provided proof-of-concept that oral inhaled flecainide with an administration regimen of eight minutes can safely and rapidly convert recent-onset PAF to normal sinus rhythm. InCarda plans to initiate a single pivotal Phase 3 trial of InRhythm in Q3 2021. With intellectual property protection through 2040, InRhythm represents a first-in-class, potential 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 (e.g., 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 advancing toward Phase 3 development to treat acute episodes of PAF, a prevalent atrial arrhythmia. For more information, please visit: www.incardatherapeutics.com.
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Twitter: @InCardaThera
References:
1 J Am Coll Cardiol. 2014 Dec 2;64(21):2305-7
2 Am Heart J. 2005 Mar;149(3):489-96
