New Patent Issuances Strengthen InCarda Therapeutics’ Intellectual Property Portfolio Covering Novel Inhaled Cardiovascular Therapies
U.S. Patent Broadly Expands Coverage for Inhaled Treatment of Cardiovascular Disease to Include all Class I – IV Antiarrhythmic Drugs
Additional U.S. Patent Provides Coverage for Combination of Arrhythmia Electronic Monitoring with Treatment Initiation; Supports Vision of Empowering Patients to Rapidly Detect and Arrest Atrial Fibrillation on Their Own
San Francisco, CA – February 7, 2019 – InCarda Therapeutics, Inc. (“InCarda”), a privately-held biopharmaceutical company developing first-of-their-kind inhaled therapies for cardiovascular diseases, today announced that new U.S. patents have been issued by the U.S. Patent and Trademark Office (USPTO). The two new patents provide the company with significantly expanded intellectual property (IP) protection for its lead program, InRhythm™ and potential follow-on therapeutic programs designed to treat cardiac arrhythmias with drugs delivered via inhalation. Specifically, this new IP covers the pulmonary delivery of a broad range of antiarrhythmic drugs, as well as the combination of electronic cardiac arrhythmia monitoring with the initiation of inhaled therapy for treatment of cardiac arrhythmia.
“Taken together, these new patent issuances serve the important purpose of positioning InCarda at the forefront of developing cardiovascular therapies to be delivered via inhalation, particularly for cardiac arrhythmias,” said Carlos Schuler, Ph.D., co-founder and chief operating and technology officer of InCarda. “Whether it is providing freedom to operate and protection to incorporate a broader range of therapeutic agents into novel inhaled treatments, or allowing us to pursue our vision of empowering patients to take treatment of atrial fibrillation into their own hands, these patents support the expansion of our pipeline.”
Expanded Coverage of Antiarrhythmic Therapy:
U.S. Patent No. 10,045,939 represents a continuation to InCarda’s original patent, expanding its coverage to include pulmonary delivery of all antiarrhythmic drugs categorized as class I, II, III or IV under the Vaughan Williams classification system. The company’s original patent focused specifically on the pulmonary administration of flecainide, which is the basis for the company’s InRhythm program, currently in a Phase 2 clinical study in patients with recent onset paroxysmal atrial fibrillation (PAF). This latest patent provides the opportunity for InCarda to pursue additional pulmonary product opportunities incorporating other antiarrhythmic agents to treat a full range of arrhythmias beyond atrial fibrillation.
Separately, the company anticipates the issuance of a European patent that will offer protection for the pulmonary delivery of flecainide in Europe during the first half of 2019.
Combination of Electronic Monitoring and Treatment Initiation:
U.S. Patent 10,010,294 provides coverage for approaches and/or products that combine electronic cardiac arrhythmia monitoring with the initiation of inhaled arrhythmia therapy. These claims allow InCarda to pursue product development opportunities leveraging antiarrhythmic drugs delivered via inhalation, including InRhythm, in combination with arrhythmia monitoring and detection devices. The company views this as a potentially significant patent based on recent advances in active arrhythmia monitoring using wearables and other portable devices.
“At InCarda, we are driven by a vision of enabling patients to rapidly self-administer drugs to treat and terminate episodes of atrial fibrillation upon detection, whenever necessary and wherever the patient may be. InRhythm and future InCarda products should make arrhythmia monitoring technologies more actionable, empowering patients and reducing healthcare utilization,” said Grace Colón, Ph.D., president and chief executive officer of InCarda. “Securing this important intellectual property strongly positions InCarda to ultimately deliver on this promise to patients. We look forward to the opportunity to continue to work collaboratively with others who share this vision.”
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 PAF rely upon either chronic administration of oral antiarrhythmic drugs or acute hospital-based procedures such as intravenous drug administration, electrical cardioversion and catheter ablation. 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, restoring normal sinus rhythm (NSR) and relieving the patient’s symptoms following the onset of an episode of atrial fibrillation (AF). InRhythm is intended to address the unmet need for a non-invasive, rapid-acting treatment that can be self-administered by patients whenever they experience intermittent episodes of AF. 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 a Phase 2 trial of InRhythm in patients with recent-onset PAF. For more information about this study, please visit: https://clinicaltrials.gov/ct2/show/NCT03539302.
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, can be patient self-administered in any setting. 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 paroxysmal atrial fibrillation (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