AnaCardio successfully completes first part of AC01 HFrEF study and provides a clinical update

AnaCardio, a Swedish clinical-stage biopharmaceutical company developing novel contractile agents to treat patients with heart failure, today announced that the clinical conduct of the first part of its GOAL-HF1 study in patients with heart failure and reduced ejection fraction (HFrEF) has been completed. Part A of GOAL-HF1 is a randomized, double-blind, placebo-controlled, dose-escalation study (Phase 1b), designed to assess the safety, pharmacokinetic and pharmacodynamic properties of AC01. A total of 32 patients, 8 in each of 4 sequential dose cohorts, were treated with ascending doses of AC01 or placebo for 7 days; all patients completed the study according to plan. The cohort extension phase of GOAL-HF1 (Part B/Phase 2a) is expected to be initiated in Q1’25. More information about the study is available at www.clinicaltrials.gov (NCT05642507).

AnaCardio also announces the completion of the AC01-FE study, conducted in the US, evaluating the effects of food on the pharmacokinetics of AC01 in healthy volunteers. All 24 participants completed the study; AC01 was safe and well-tolerated under both fed and fasted conditions.

”The successful completion of these studies represents a significant development milestone for AC01. We are encouraged by the emerging data and clinical experience with AC01, which support advancement to the next part of GOAL-HF1 where we will treat patients with HFrEF for a longer duration in a Phase 2a setting, as well as intensifying our preparations for subsequent larger trials.” commented Allan Gordon, Chief Medical Officer AnaCardio.

About AnaCardio

AnaCardio AB is a privately held Swedish, clinical stage biopharmaceutical company developing novel drugs to treat heart failure. AnaCardio was founded based on ground-breaking research from Karolinska Institutet showing improved contractility of the heart muscle through a unique and differentiated mechanism. Its lead program AC01 is an oral ghrelin peptidomimetic small-molecule is being developed as a contractile agent in heart failure patients.

You can find more information about AnaCardio at www.anacardio.com.

For further information, please contact

Patrik Strömberg, CEO

Telephone: +46 704 156 159

E-mail: patrik.stromberg@anacardio.com