Positive Data from Completed InRhythm Phase 2 Study Demonstrate Safe and Rapid Conversions from Atrial Fibrillation to Normal Sinus Rhythm
Plans to Initiate RESTORE1: Single Pivotal Phase 3 Trial in Atrial Fibrillation in Q3 2021; Data Expected 2H 2022
Appointment of Angela Wang as CFO Strengthens Management Team and Supports Key Near-Term Financial and Operational Objectives
San Francisco, CA – June 9, 2021 – InCarda Therapeutics, Inc. (“InCarda”), a privately-held biopharmaceutical company developing first-in-class inhaled therapies for cardiovascular diseases, today provided a broad corporate update highlighting significant progress for the company’s last-stage development program for InRhythm™ (flecainide for inhalation) in patients with atrial fibrillation, as well as the expansion of its senior management team. These recent developments, including a positive data readout from the completed multinational INSTANT Phase 2 clinical trial of InRhythm in patients with recent-onset paroxysmal atrial fibrillation (PAF) and the appointment of Angela Wang as chief financial officer, position the company well to support its near-term financial and operational objectives.
INSTANT Phase 2 Study Data Readout
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 sinus rhythm (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).
InCarda recently completed the Part B confirmatory cohort portion of the INSTANT Phase 2 study using the selected optimal therapeutic dose of 120 mg from the study’s previously completed Part A. Data from the Part B confirmatory cohort, which corroborated the previously reported positive results from Part A of the study, demonstrated that oral inhaled flecainide can safely and rapidly convert recent-onset PAF to SR. Specifically, 50% of Part B patients who received InRhythm achieved a successful conversion from PAF to SR within 90 minutes of initiating the inhalation. This 90-minute conversion rate for InRhythm is seen in market research as attractive by physicians who treat this condition and it exceeds that of intravenous (IV) ibutilide (38-40%, per label), which is the only FDA-approved drug for acute conversion of PAF episodes. Importantly, the successful conversion rates with InRhythm occurred rapidly, with a median time to conversion of approximately eight minutes after completing the administration of the treatment. Furthermore, no serious cardiovascular adverse events were observed.
Planned Single Pivotal Phase 3 Trial – RESTORE1
Based on these positive Phase 2 study results, along with recent interactions with the U.S. Food and Drug Administration (FDA), InCarda plans to conduct a single pivotal Phase 3 trial of InRhythm in patients with recent-onset PAF. Discussions with FDA of the planned Phase 3 study included overall design, number of patients, safety definitions and endpoints. The company expects to initiate the Phase 3 study in Q3 2021, with data expected in the second half of 2022. Should results from the study be positive, the Phase 3 data will form the basis for a New Drug Application for InRhythm to be used for acute conversion of recent-onset PAF to SR.
Appointment of Chief Financial Officer
To support the company’s ongoing growth, as well as near-term fundraising and operational objectives, InCarda has appointed Angela Wang as CFO. Ms. Wang has more than 25 years of financial and commercial leadership experience in the pharmaceutical and biotech industry in the U.S., Europe and Asia. Prior to joining InCarda, she was the CFO at MAIA Biotechnology, Inc., where she led finance operations, fundraising, investor relations, strategic financial planning, treasury, tax, and corporate business development.
During her career, Ms. Wang has also served as a member of corporate management in several global pharmaceutical and life science companies including Novartis, Sanofi, and Syngenta, where she built and led cross-function teams covering finance, legal, supply chain and site management, supporting operations generating over $1 billion in sales. In addition to her expertise in finance, she has held commercial leadership positions across various other functions, including business unit sales and marketing, business development and licensing, and strategic planning. Earlier in her career, Ms. Wang was with Deloitte and Arthur Andersen providing financial consulting and audit advisory services to both public and private companies.
“With excellent efficacy and safety data in hand from the completed Phase 2 INSTANT trial, as well as positive communication with FDA regarding our Phase 3 program, InCarda is poised for the next phase of company growth,” said Grace Colón, Ph.D., president and chief executive officer of InCarda. “We are excited to add Angela to our senior management team and look forward to leveraging her considerable financial and operational skills and expertise as we seek to raise an additional round of private funding and prepare for potential near term access to the public markets.”
“I am thrilled to join the InCarda team at this exciting time in the company’s growth trajectory, with the recent successful completion of the INSTANT Phase 2 study and planning underway for a pivotal Phase 3 trial of InRhythm. There is a significant need for new treatments that can make a meaningful impact in the lives of the millions of patients suffering with atrial fibrillation and I am proud to join a company that is developing truly innovative solutions for these patients. I look forward to contributing to InCarda’s deep in-house expertise and working with such an experienced and impressive team and board of directors,” said Ms. Wang.
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.
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. 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.
1 J Am Coll Cardiol. 2014 Dec 2;64(21):2305-7
2 Am Heart J. 2005 Mar;149(3):489-96
Source: Incarda Therapeutics