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]

Group 1 - Karolinska Development's portfolio company AnaCardio has completed enrollment in the phase 2a part of its clinical study GOAL-HF1, which evaluates the drug candidate AC01 in patients with heart failure and reduced ejection fraction, with results expected by the end of the year [1][4] - The phase 2a study includes 26 patients and aims to assess safety, tolerability, pharmacokinetics, and pharmacodynamics after 28 days of treatment, conducted at 13 specialized heart failure centers across Sweden, the Netherlands, Italy, and the UK [3] - Karolinska Development holds a 10 percent ownership stake in AnaCardio, indicating a vested interest in the success of the clinical study and the advancement of the drug candidate [4] Group 2 - AnaCardio AB is a privately held Swedish biopharmaceutical company focused on developing novel drugs for heart failure, with its lead asset AC01 currently in a clinical phase 1b/2a study [2] - Karolinska Development is a Nordic life sciences investment company that identifies and invests in breakthrough medical innovations, aiming to create and grow companies that develop these innovations into commercial products [5][6] - The company has a portfolio of eleven companies targeting innovative treatments for serious diseases, supported by a team of experienced investment professionals and a strong global network [7]