InCarda Therapeutics announces enrolment of first US patient in phase 2 INSTANT trial


InCarda Therapeutics has announced dosing of the first US patient in the company’s multinational INSTANT Phase 2 clinical trial of InRhythm (flecainide for inhalation) in patients with recent-onset paroxysmal atrial fibrillation (PAF). The trial is currently being conducted at centres in the USA and Europe to evaluate the optimal dose (120 mg) of InRhythm that was selected based on the positive results from the open-label, dose-ranging stage of the INSTANT study.

The results from the dose-ranging stage of the trial were recently presented at the American Heart Association’s (AHA) Scientific Sessions 2020 (13 – 17 November, virtual). InCarda Therapeutics in collaboration with clinical investigators reported that oral inhaled flecainide can safely and rapidly convert recent-onset PAF to normal sinus rhythm (NSR). These data provided the first proof of concept for inhaled flecainide as a potentially safe and effective therapeutic option for rapidly converting PAF to NSR.

The second stage of the INSTANT trial was initiated in October 2020 at centres in The Netherlands and Belgium, and was expanded to the USA with MemorialCare Long Beach Medical Center as the first US site. The company plans to initiate a companion Phase 2 trial during the first half of 2021 in which patients who have already undergone a safe cardioversion with InRhythm will be trained to self-administer InRhythm under medical supervision when another (“recurrent”) episode of PAF occurs.

“Atrial fibrillation is the most common heart rhythm disorder in the USA Left untreated, patients in AF experience disabling symptoms, are at greater risk for stroke, and increase utilisation of hospital resources. At present, options for rapid conversion of AF into a normal rhythm are limited to oral or intravenous medications and electrical cardioversion,” said Mark Y Lee, the principal investigator of the INSTANT trial at MemorialCare Long Beach Medical Center. “Flecainide delivered via oral inhalation can be easily administered to rapidly convert AF into sinus rhythm. If the clinical trial is successful, patients in AF may one day have access to a non-invasive option for the rapid restoration of normal rhythm, and may ultimately be able to use it at home when shown to be safe.”

Luiz Belardinelli, chief medical officer of InCarda Therapeutics commented: “InCarda is testing the safety, tolerability and efficacy of administering flecainide via oral inhalation to restore normal sinus rhythm in patients with symptomatic episodes of recent onset of AF. While until now the clinical investigation of this product has been conducted in Europe, development plans have always included testing at US hospital sites. Thus, we are delighted to announce that the first US patient has been successfully enrolled in the INSTANT trial, and grateful to Mark Y Lee and his team for helping us investigate this novel, non-invasive approach to deliver flecainide safely and rapidly restore normal sinus rhythm.”


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