(2S)-2-[[2-[[(2S)-5-AMINO-2-[[(2S)-2-AMINOPROPANOYL]AMINO]-5-OXOPENTANOYL]AMINO]ACETYL]AMINO]-3-METHYLBUTANOIC ACID for Coronary artery disease

Inclusion criteria

• {"criterion_text":"- Patients aged ≥18 years, both male and female.\n- Patients scheduled for elective on-pump CABG with at least 3 bypasses, with or without valve replacement.\n- For women of childbearing potential (WOCBP), agree to use adequate contraception from enrollment and up to 28 days after IMP administration, and must have a negative pregnancy test prior to entry into the trial\n- For male patients, agree to use adequate contraception and refrain from donating sperm from enrollment and up to 28 days after IMP administration.\n- Willing and able to give written informed consent"}

Exclusion criteria

• {"criterion_text":"- Patients undergoing non-elective on-pump CABG (i.e., emergency surgery). Emergency surgery is defined as planned surgery within 24 hours of diagnosis.\n- Patients with hematological disorders (known disorders from myeloid and/or lymphoid origin, leucopenia (both active and in remission)).\n- Known severe renal disease requiring dialysis, or a known estimated Glomerular Filtration Rate (eGFR) prior to admission of < 20 ml/min/1.73 m2.\n- Women who are pregnant, breastfeeding or planning to become pregnant during the trial or within 28 days after IMP administration.\n- Previous receipt of EA-230.\n- Known hypersensitivity to the IMP.\n- Use of any investigational drug within 1 month or 5 half-lives of said investigational drug (whichever is longer) prior to IMP administration in this trial. Participation in an observational clinical trial is not exclusionary.\n- Patients (or partners of patients) not willing to use a reliable method of contraception from enrollment and up to 28 days after IMP administration.\n- Patients who are unable to communicate effectively in the local language of the trial site, at the discretion of the Investigator.\n- Inability to personally provide written informed consent\n- Known or suspected of not being able to comply with the trial protocol, at the discretion of the Investigator.\n- Cardiogenic shock or hemodynamic instability that requires inotropes, vasopressors, or other mechanical devices, such as an intra-aortic balloon counter-pulsation (IABP), within 24 hours prior to surgery.\n- Any other condition which, in the Investigator’s opinion, will interfere with completion of the trial.\n- Being an employee of the Investigator or trial site with direct involvement in the proposed trial or other studies under the direction of that Investigator or trial site or being a family member of an employee of the Investigator with direct involvement in the proposed trial.\n- Use of a left ventricular assist device (LVAD), or intra-aortic balloon pump or other cardiac devices, within 7 days prior to surgery.\n- A requirement for any of the following within 7 days prior to surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, LVAD, or other forms of mechanical circulatory support.\n- Required cardiopulmonary resuscitation within 14 days prior to cardiac surgery.\n- Known chronic liver disorder with Child-Pugh C classification.\n- Confirmed or treated endocarditis requiring antimicrobial or antiviral treatment within 30 days prior to surgery or other current active infection requiring antimicrobial or antiviral treatment within 14 days prior to surgery.\n- Ongoing sepsis (as defined by SEPSIS-3) within 2 weeks of screening or, in the opinion of the investigator, an untreated clinically significant infection (viral or bacterial) prior to or at Screening and before randomization.\n- Immuno-compromised patients, as self-reported or as observed in medical records, including patients: a. with solid organ transplantation. b. known to be positive for human immunodeficiency virus (HIV). c. that use immunosuppressive drugs or have received recent chemotherapy, at the discretion of the Investigator and including patients; i. with active malignancy who have undergone chemotherapy within 30 days prior to trial entry. ii. receiving chronic corticosteroid treatment equivalent to a prednisone dose of 10 mg or higher per day, within 30 days prior to trial entry, or an equivalent dose of another corticosteroid or any other anti-inflammatory or inflammation-suppressing medications such as interleukin blockers, methotrexate or similar therapies. Non-Steroidal Anti-Inflammatory Drugs are not exclusionary."}

Primary endpoints

• {"endpoint_text":"- As measured by the median postoperative duration, from the moment of first incision until the time when a patient is eligible to be discharged from the hospital, compared between treatment arms, according to the definitions provided in Summary Table 4. ICU and Hospital Discharge Criteria.","definition_or_measurement_approach":"Median postoperative duration measured from first incision until time when patient is eligible for hospital discharge; comparison between treatment arms using definitions in Summary Table 4 (ICU and Hospital Discharge Criteria)."}

Secondary endpoints

• {"endpoint_text":"- As measured by the median postoperative duration, from the moment of first incision until the time when a patient is eligible to be discharged from the ICU and transferred to the general ward, compared between treatment arms, according to the definitions provided in Summary Table 4. ICU and Hospital Discharge Criteria.\n- As measured by the median postoperative duration, from the moment of first incision until the time when a patient is actually discharged from the ICU, and discharged from the hospital, respectively, compared between treatment arms.\n- As measured by the median cumulative duration of moderate and severe Single Organ Outcome Measures (SOOMs) according to the European Perioperative Clinical Outcome (EPCO) definitions during the trial compared between treatment arms.\n- As measured by: A. Median cumulative Net Fluid Balance (NFB) at the start of Investigational Medicinal Product (IMP) administration (T0) and up to 24 and 48 hours thereafter, compared between treatment arms. B. Cumulative dose of vasopressors and inotropes used and vasopressor-inotropic scores up to 0, 24 and 48 hours after IMP administration, compared between treatment arms.\n- As determined by: A. Blood plasma levels of EA-230 measured just before the end of infusion (T4) in all patients. B. Blood plasma levels of EA-230 measured at T0, T0.5, T1, T2, T3 and T4 in a subset of patients .\n- As measured by the Incidence of treatment-emergent (Serious) Adverse Events ((S)AEs) and Adverse Drug Reactions (ADRs) during the trial period.","definition_or_measurement_approach":"Secondary endpoints include various median postoperative durations (ICU transfer eligibility, actual ICU/hospital discharge), median cumulative duration of moderate/severe SOOMs per EPCO definitions, Net Fluid Balance at T0/T0+24/48h, cumulative vasopressor/inotrope doses and scores to 0/24/48h, PK plasma levels at specified timepoints (T0, T0.5, T1, T2, T3, T4; all patients at T4), and incidence of treatment-emergent (S)AEs and ADRs; comparisons are between treatment arms as specified."}

Belgium

Earliest CTIS Part Ii Submission Date

30-03-2026

Latest Decision Or Authorization Date

29-04-2026

Processing Time Days

30

Number Of Sites

1

Number Of Participants

50

Netherlands

Earliest CTIS Part Ii Submission Date

03-04-2026

Latest Decision Or Authorization Date

29-04-2026

Processing Time Days

26

Number Of Sites

2

Number Of Participants

100

Primary sponsor

Full Name

EBI Anti Sepsis B.V.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Netherlands