Proceeds to Support Ongoing Clinical Development of InRhythm™, A First-of-its-Kind Inhaled Antiarrhythmic for Treatment of Paroxysmal Atrial Fibrillation (PAF)
Positive Phase 2 Data Scheduled for Presentation at American Heart Association Scientific Sessions 2020; Pivotal Phase 3 Study Planned for Initiation in H1 2021
SAN FRANCISCO, Oct. 21, 2020 (GLOBE NEWSWIRE) — InCarda Therapeutics, Inc. (“InCarda”), a privately-held biopharmaceutical company developing first-of-their-kind inhaled therapies for cardiovascular diseases, today announced that it has raised $30 million through the first close of a Series C equity financing. The financing was led by an affiliate of Innoviva, Inc. and also included existing investors Deerfield Management, HealthCap and Morningside Venture. Proceeds from the financing will be used primarily to fund the ongoing clinical development of InRhythm™ (flecainide for inhalation), the company’s lead program, for the treatment of a recent-onset episode of paroxysmal atrial fibrillation (PAF).
As part of the initial close of the Series C financing, InCarda has expanded its board of directors to include George Bickerstaff, co-founder and managing director of M.M. Dillon & Co. and a member of Innoviva’s board of directors. Mr. Bickerstaff has held a number of board and executive roles in the healthcare, pharmaceutical and information technology sectors, and previously served as chief financial officer of Novartis Pharma AG and of IMS Health.
InRhythm Clinical Development:
InRhythm 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 to relieve symptoms associated with acute episodes of PAF. The therapy is being developed initially for its use under medical supervision in a hospital, emergency room or physician office, and subsequently as a portable treatment that can be self-administered by patients in a non-medically supervised setting, such as the home, to rapidly achieve conversion of PAF to NSR.
The company has successfully completed the open-label, dose-escalation Part A portion of its multinational INSTANT Phase 2 clinical trial of InRhythm in patients with recent-onset PAF and will present the results of the study at the upcoming American Heart Association’s (AHA) Scientific Sessions being held virtually November 13-17, 2020. The data to be presented will highlight the successful demonstration of the target therapeutic profile for InRhythm and the company’s selection of an optimal therapeutic dose for continued clinical development.
InCarda has commenced enrollment of the next stage of the INSTANT study, which includes a confirmatory cohort using the selected optimal therapeutic dose, and a pilot study, referred to as the patient-led substudy. In this study, patients who already experienced a safe cardioversion with InRhythm will receive training so that they can self-administer InRhythm, under medical supervision, when another (“recurrent”) episode of PAF occurs. Additionally, InCarda is finalizing plans for its multinational, pivotal Phase 3 trial of InRhythm in a medically supervised setting, which is expected to be initiated in the first half of 2021.
“This is a very exciting time at InCarda as we expect to achieve a number of critical value-creating milestones in the coming months,” said Grace E. Colón, Ph.D., president and chief executive officer of InCarda. “This capital raise places InCarda in an excellent position to continue our progress with the InRhythm program, while also leveraging our technical and scientific expertise to strategically expand our pipeline. We’d also like to welcome George Bickerstaff to the board and look forward to benefiting from his impressive experience in pharma to support InCarda at this particularly critical juncture in the company’s development.”
“InCarda is addressing a significant unmet medical need with a highly novel approach. I am impressed with the strength of the team and positive data to date,” said George Bickerstaff, new InCarda board member. “I believe that InCarda has identified differentiated opportunities that will dramatically improve quality of life and outcomes for patients with serious medical conditions and look forward to multiple key company milestones in 2021.”
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 are often debilitating. A chronic, progressive condition, AF is estimated to affect up to 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. The underlying cause of PAF is unknown and most patients present with a normal heart structure. 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. 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 continued/prolonged 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 in Phase 2 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
Contact Information: Tim Brons Vida Strategic Partners (media) 646-319-8981