AnaCardio Receives Regulatory Approval to Start a Phase 1b/2a Clinical Study in Heart Failure with AC01 in the EU and UK
STOCKHOLM, SWEDEN - 17 November 2022: AnaCardio today announces approval for the GOAL-HF1 Phase 1b/2a study from the competent authorities and ethics committes in Sweden, The Netherlands, Italy and the United Kingdom. This 28-day study will evaluate the effects of orally administered AC01 on safety, tolerability, pharmacokinetics and a series of pharmacodynamic readouts in patients with heart failure with reduced ejection fraction (HFrEF). The study was submitted for approval in EU under the Clinical Trial Regulation (CTR), making it one of the first studies to be approved under the new EU