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Trial Underway for Inhaled Heart Rhythm Drug, Developer Raises $42M

Heartbeat graphic


8 Nov. 2018. A clinical trial is underway testing an inhaled therapy to quickly treat irregular heart rhythms, in cases where the problems occur occasionally and often resolve on their own. In addition, InCarda Therapeutics Inc., the company making the treatments, is raising $42 million in its second venture funding round.

InCarda Therapeutics, based in San Francisco, develops inhaled medications for heart disorders. Its lead product, known as InRhythm, is made for people occasional cases of atrial fibrillation, a disorder where the atria, or upper chambers of the heart, beat irregularly instead of the normal, smooth regular beats that move blood effectively through the blood stream. Because of these irregular heart rhythms, blood can pool in the atria and form clots. If a clot should break off and flow to the brain, it can cause a stroke. According to American Heart Association, 15 to 20 percent of people who have a stroke also have atrial fibrillation.

These occasional cases of the condition are called paroxysmal atrial fibrillation, which also stop spontaneously after a few seconds up to a few days. InCarda says current drugs are designed for chronic or severe cases of atrial fibrillation that may require hospitalization, not for the occasional, short-term episodes found with paroxysmal atrial fibrillation. InRhythm delivers the current established anti-arrhythmic drug flecainide as an inhaled treatment that delivers the medication through the lungs into the blood stream. The treatment’s goal is to quickly return the individual’s heartbeats to a normal rhythm.

The mid-stage clinical trial is enrolling 110 participants with recent paroxysmal atrial fibrillation, or PAF. The first part of the trial is assessing the feasibility of taking an inhaled form of flecainide, while the second part is testing safety and effectiveness of InRhythm against a placebo. Participants will be tracked remotely from their local hospitals, where results of electrocardiograms, or ECGs, will be sent after they experience an atrial fibrillation episode. The study is also evaluating safety and chemical actions in the body of the inhaled drug, with initial results expected in the second half of 2019.

Grace Colón, president and CEO of InCarda, says in a company statement that the new clinical trial, “will serve as an important step in our continued effort to develop a novel treatment capable of addressing the unmet needs of patients living with the significant clinical and emotional burden of PAF.”

InCarda also completed its second round of venture financing, raising $42 million. The funding round was led by biotech and life science investor companies Sofinnova Ventures and Health Cap, joined by new investor Deerfield Management and current investors Morningside Venture and Asset Management Ventures. Proceeds from the financing are expected to mainly support the new clinical trial.

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