InCarda stops Phase III study of inhaled antiarrhythmic drug
12 Jun 2023
Phase 3Phase 2Clinical Trial Termination
InCarda Therapeutics has discontinued a Phase III trial evaluating its lead product candidate, an orally inhaled formulation of the antiarrhythmic agent flecainide. According to a recent entry posted on ClinicalTrials.gov, the RESTORE-1 trial was terminated due to "limited efficacy upon blinded review."
The Phase III trial had so far recruited 54 patients with recent-onset, symptomatic newly diagnosed or paroxysmal atrial fibrillation (PAF), although it was targeted to enrol approximately 400 patients in all. Subjects were randomised to receive the company's inhaled flecainide therapy, known as FlecIH-103 and as InRhythm, at up to 120mg estimated total lung dose, or placebo.
The trial got under way in April last year. On its website, InCarda says its drug, which is delivered via nebulisation, is "designed to rapidly deliver flecainide…to the heart via the lungs, converting patients back to a sinus rhythm and relieving symptoms following the onset of a PAF episode." The company's site indicates that it is also currently conducting the Phase II INSTANT trial of the inhaled therapy in patients with recent-onset PAF.
InCarda raised $30 million through the first close of a Series C equity round in 2020. The financing was led by an affiliate of Innoviva, and also included existing investors Deerfield Management, HealthCap and Morningside Venture.
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