Karolinska Development’s portfolio company AnaCardio presents positive top-line data from the phase 2a study of its drug candidate AC01

Core Insights - Karolinska Development's portfolio company AnaCardio has reported positive results from the phase 2a clinical trial GOAL-HF1 for the drug candidate AC01, aimed at treating heart failure with reduced ejection fraction (HFrEF) [1][5] - The study met its primary endpoint, demonstrating a favorable safety and tolerability profile, and showed encouraging efficacy signals, leading to plans for a phase 2b trial [1][5] Company Overview - AnaCardio AB is a privately held Swedish biopharmaceutical company focused on developing novel drugs for heart failure [2] - Karolinska Development holds a 10 percent ownership stake in AnaCardio [6] Clinical Trial Details - The phase 2a study enrolled 26 patients across 13 European heart failure centers, with participants receiving either 1 mg or 3 mg of AC01 or a placebo twice daily for 28 days [3] - Exploratory efficacy assessments indicated rapid and sustained improvements in haemodynamics and cardiac structure and function over the treatment period [3] - The pharmacokinetics of AC01 were predictable and dose-proportional, with confirmed target engagement through a dose-dependent increase in growth hormone release [4] Safety Profile - No treatment-emergent adverse events leading to discontinuation or serious adverse events were reported, nor were there any clinically relevant effects on blood pressure [5] - The CEO of Karolinska Development expressed confidence in AC01's potential to transform heart failure treatment based on the study's strong data [5]