InCarda Therapeutics Initiates Enrollment of Phase 1 Clinical Trial of Inhaled Flecainide for the Treatment of Cardiac Arrhythmias
San Francisco, California, August 31, 2016 – InCarda Therapeutics, Inc. (InCarda), a privately-held biopharmaceutical company pioneering a novel approach of treating cardiovascular conditions by delivering medications via the inhalation route, today announced that it has initiated a Phase 1 clinical trial for its lead product intended to treat recent onset atrial fibrillation (AF). The single-center trial will evaluate the safety and tolerability of inhaled flecainide in a randomized, double-blind, placebo-controlled design consisting of single ascending doses of inhaled active solution, or inhaled placebo solution, in multiple cohorts of healthy volunteers. This study is being conducted at CMAX, a division of IDT Australia.
“This is an important step in advancing InCarda’s lead product into clinical development,” stated Narsi Rangachari, co-founder and chief operating officer of InCarda Therapeutics. “With its novel delivery approach, InCarda is uniquely positioned to develop this rapid-onset treatment for patients with paroxysmal AF.”
“The initiation of this trial in Australia represents a key milestone for InCarda,” stated Grace E. Colon, Ph.D., chief executive officer and president of InCarda. “Last October we put in place a subsidiary in Australia to allow us to take advantage of leading investigators, medical centers and infrastructure in this important region of medical research, and we also benefit from substantial subsidies that we are applying to our clinical development activities.”
InCarda’s Lead Product for PAF
Paroxysmal atrial fibrillation (PAF), the most common type of cardiac arrhythmia (abnormal heart rhythm) is characterized by rapid and irregular heartbeats that often leads to palpitations and other disabling symptoms (e.g., fatigue). Flecainide is a commonly prescribed antiarrhythmic drug. InCarda is evaluating an inhaled formulation of this drug for patients experiencing recent episodes of AF. Inhaled delivery offers the potential for faster cardioversion at onset of AF symptoms, whenever and wherever they occur.
About InCarda (www.incardatherapeutics.com)
InCarda Therapeutics, located in the San Francisco Bay Area with operations in Australia, is focused on transforming cardiovascular disease treatment through pulmonary delivery of established drugs. The company is product-focused with significant capabilities and is led by a team with extensive experience in drug development. The lead product under development is a clinical-stage inhaled therapy intended to treat paroxysmal atrial fibrillation (PAF). InCarda is also working on additional research concepts that leverage the same platform technology to target the heart for acute cardiac conditions. The company’s approach is designed to reduce the risk normally associated with drug development. InCarda’s model is based on the following three tenets: known diseases, known drugs, new delivery.