Treatments for patients who have atrial fibrillation (AF), an irregular heartbeat, include pills that take time to work, or hospital-based procedures. InCarda Therapeutics aims to offer an alternative: a fast-acting inhalable drug that patients would take at home. The startup is moving ahead with mid-stage clinical testing of its drug and has raised $42 million to support that research.
New investors Sofinnova and HealthCap led the Series B round of financing.
As many as 6.1 million people in the U.S. have atrial fibrillation, according to the Centers for Disease Control and Prevention. That figure is expected to increase as the population ages. The condition leads to more than 750,000 hospitalizations annually, at a cost of $6 billion, CDC figures show. Newark, CA-based InCarda aims to treat paroxysmal atrial fibrillation (PAF), a type of AF that begins suddenly and ends within a week, but can progress to a permanent form for a quarter of PAF patients, according to the company. Symptoms include a racing heartbeat, chest pain or pressure, weakness, and dizziness.
PAF treatment includes pills, intravenous drugs that must be taken in a hospital, or medical procedures such as a catheter ablation or electrical treatment to shock the heart back into a normal rhythm.
One of the medications approved to treat PAF, the off-patent drug flecainide, comes in pill form but is slow to act. InCarda has developed an inhalable form of flecainide that it calls InRhythm. The company says its version of the drug was developed to deliver the drug to the heart via the lungs, an approach intended to more quickly relieve PAF symptoms. InCarda says patients would be able to administer the drug themselves, or it could be given under medical supervision in a healthcare facility.
InCarda’s Phase 2 study is enrolling 110 patients who have recent-onset PAF. The clinical trial consists of two parts. The first is an open-label study testing two doses of the InCarda drug, which will be administered via a nebulizer. The second part will be a randomized, double-blind, placebo-controlled study evaluating the drug’s efficacy. The company expects to report preliminary results from the study in the second half of 2019.
Other groups that joined InCarda’s latest financing include new investor Deerfield Management and earlier investors Morningside Venture and Asset Management Ventures.
Anatomy of the lungs and heart image by Flickr user University of Liverpool Faculty of Health & Life Sciences via a Creative Commons license