Phase 2 Study to Assess Efficacy and Safety of CDR132L in Patients with Reduced Left Ventricular Ejection Fraction (≤45%) After Myocardial Infarction (HF-REVERT)

Prior treatment

• Patient is not to be enrolled into the study if they received any prohibited therapy within 3 months of screening.

Other illness

• Patient has poorly controlled diabetes as determined by the Investigator.
• Patient with active and clinical relevant "severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)" infection confirmed as per the local testing guidelines at screening.
• Patient with New York Heart Association (NYHA) class IV at screening or randomization.
• Patient has any planned cardiac intervention (angiogram without angioplasty is acceptable) or any other planned surgery after the Screening Period.
• Patient has severe valvular heart disease.
• Patient has systolic BP < 90 mmHg or > 180 mmHg, diastolic BP < 50 mmHg or > 110 mmHg, and/or heart rate < 50 or > 100 beats/minute at screening or randomization.
• Patient with hepatic insufficiency classified as Child-Pugh B or C.
• Patient has medical history of disease(s) affecting the blood-brain-barrier, e.g., stroke within 6 months or multiple sclerosis.

Lab values

• Patient has medical history of bleeding disorders or has thrombocytopenia (platelets < 100,000/μL).
• Patient has a history or presence of any of the following cardiac conditions: known structural cardiac abnormalities beyond HF, family history of long QT syndrome, cardiac syncope, or recurrent, idiopathic syncope.

Other

• A woman of childbearing potential (WOCBP).
• Any clinically significant abnormalities, at the discretion of the Investigator, in rhythm, conduction, or morphology of resting ECG that pose an additional safety risk to patients.
• Patient with HF of non-ischemic origin; e.g., myocarditis, alcoholic cardiomyopathy.
• Patient with an estimated glomerular filtration rate < 30 mL/min/1.73 m2 or on dialysis.

• Male or female patients, aged ≥ 30 to ≤ 80 years at the date of signing informed consent which is defined as the beginning of the Screening Period.
• Spontaneous acute mycardial infarction (AMI) (type I) based on the universal MI definition with randomization to occur no later than 14 days after index event diagnosis.
• Patient with a LVEF ≤ 45% as measured by ECHO after MI diagnosis (STEMI or NSTEMI).
• Patient with previous MI events in history can be included.
• Patient with body weight of ≤ 120 kg.
• N-terminal pro B-type natriuretic peptide level ≥ 125 pg/ml and < 8000 pg/ml at screening.
• Patient with STEMI/NSTEMI who underwent percutaneous coronary intervention for this event.