Immunomodulation of EA-230 Following On-pump Coronary Artery Bypass Grafting (CABG)

Summary

EA-230 is a newly developed synthetic compound with anti-inflammatory properties, it is a linear tetrapeptide derived from the human chorionic gonadotropin hormone (hCG). Recently, its immunomodulatory effects in humans were confirmed in a phase I trial and an optimal dose was established. To establish this anti-inflammatory effect in a selected patient population and assess clinical outcome, a combined phase IIa/IIb trial will be conducted with patients undergoing cardiac surgery.

Timeline

Start

2016-06

Primary completion

2018-10

Completion

2018-10

Publications

• van Groenendael R, Beunders R, Hemelaar P, Hofland J, Morshuis WJ, van der Hoeven JG, Gerretsen J, Wensvoort G, Kooistra EJ, Claassen WJ, Waanders D, Lamberts MGA, Buijsse LSE, Kox M, van Eijk LT, Pickkers P. Safety and Efficacy of Human Chorionic Gonadotropin Hormone-Derivative EA-230 in Cardiac Surgery Patients: A Randomized Double-Blind Placebo-Controlled Study. Crit Care Med. 2021 May 1;49(5):790-803. doi: 10.1097/CCM.0000000000004847.
• van Groenendael R, Beunders R, Hofland J, Morshuis WJ, Kox M, van Eijk LT, Pickkers P. The Safety, Tolerability, and Effects on the Systemic Inflammatory Response and Renal Function of the Human Chorionic Gonadotropin Hormone-Derivative EA-230 Following On-Pump Cardiac Surgery (The EASI Study): Protocol for a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study. JMIR Res Protoc. 2019 Feb 6;8(2):e11441. doi: 10.2196/11441.

Drugs

Indications