STOCKHOLM, Sweden – March 26, 2026 – AnaCardio today announces that the results from GOAL-HF1, its Phase 1b/2a study of AC01 in patients with heart failure with reduced ejection fraction (HFrEF) have been selected for presentation in the Late-Breaking Science program at the Heart Failure Association (HFA) of the European Society of Cardiology (ESC) 2026 Congress in Barcelona.
Late-Breaking Science presentations are reserved for studies of high scientific and clinical importance, highlighting impactful advances in cardiovascular medicine.
The presentation, titled “Randomized, double-blind, placebo-controlled, safety, tolerability, PK, PD and exploratory efficacy phase 1b/2a trial with AC01 in patients with HFrEF” will be held by Professor Lars Lund of Karolinska University Hospital on Saturday, May 10, 15.30 CET.
GOAL-HF1 is the first clinical study in patients with the novel oral calcium-sensitising inotrope AC01, a ghrelin receptor agonist, in HFrEF and consisted of two parts: a sequential dose-escalation over seven days (Phase 1b) followed by a cohort expansion over 28 days (Phase 2a), including 58 patients enrolled at 14 sites in 4 countries in Europe. AC01 demonstrated a favorable safety and tolerability profile, achieved target engagement and exhibited promising signals of improved systolic function. These results justify advancing AC01 to Phase 2b development in HFrEF.
“We are pleased that the GOAL-HF1 results have been selected for Late-Breaking Science presentation at HFA 2026 Congress,” said Patrik Strömberg, CEO of AnaCardio. “Heart failure with reduced ejection fraction remains one of the largest areas of unmet medical need in cardiovascular medicine, with persistently high morbidity and mortality despite broad adoption of guideline-directed medical therapies. We believe AC01’s novel mechanism has the potential to address important gaps in current treatment, and we look forward to sharing these data with the scientific community.”
Presentation Details
- Event: Heart Failure Association 2026 Congress
- Session: Late-Breaking Science; Advances in heart failure detection and therapy
- Title: Randomized, double-blind, placebo-controlled, safety, tolerability, PK, PD and exploratory efficacy phase 1b/2a trial with AC01 in patients with HFrEF
- Presenter: Professor Lars Lund, Karolinska University Hospital
- Date/Time: Saturday May 10, 15.30 CET
About the GOAL-HF1 HFrEF study
GOAL-HF1 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of AC01 in patients with heart failure and reduced ejection fraction (HFrEF). All patients had NYHA class II-III heart failure with reduced ejection fraction, an ICD for primary prevention and optimized guideline-directed medical therapy.
- Phase 1b consisted of a multiple-dose escalation in 32 patients across four sequential dose cohorts (0.3–3 mg), each treated orally twice daily for 7 days.
- In Phase 2a, 26 patients were equally randomized into one of three parallel treatment arms and treated twice daily with 1 or 3 mg AC01, or placebo for 28 days.
More information about the study is available at www.clinicaltrials.gov (NCT05642507).
About AnaCardio
AnaCardio AB is a privately held 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. The Company’s lead program AC01, a first-in-class calcium sensitizing inotrope, is an oral ghrelin mimetic small-molecule, which was in-licensed from Helsinn and is now being developed as a contractile agent in heart failure patients. AnaCardio recently completed a succesful Phase 1b/2a trial with AC01 that generated proof-of-concept in patients with HFrEF, thus supporting further development of this promising oral, first-in-class drug candidate in patients with advanced heart failure.
