EA-230 / Exponential Biotherapies - LARVOL DELTA

Safety and Efficacy of Human Chorionic Gonadotropin Hormone-Derivative EA-230 in Cardiac Surgery Patients: A Randomized Double-Blind Placebo-Controlled Study. (PubMed, Crit Care Med) - "EA-230 was safe in patients undergoing on-pump cardiac surgery. It did not modulate interleukin-6 plasma concentrations but appeared to exert beneficial renal and cardiovascular effects and shortened in-hospital length of stay."

Clinical • Journal • Acute Kidney Injury • Anesthesia • Cardiovascular • Chronic Kidney Disease • Critical care • Immune Modulation • Immunology • Inflammation • Nephrology • Renal Disease • IL6

A randomized double-blind, placebo-controlled clinical phase IIa trial on safety, immunomodulatory effects and pharmacokinetics of EA-230 during experimental human endotoxaemia. (PubMed, Br J Clin Pharmacol) - "Administration of EA-230 is safe and results in attenuation of the systemic inflammatory response in humans."

Clinical • Journal • P2a data • PK/PD data • Immune Modulation • Immunology • Inflammation • Systemic Inflammatory Response Syndrome

Pharmacokinetics, safety and tolerability of the novel β-hCG derived immunomodulatory compound, EA-230. (PubMed, Br J Clin Pharmacol) - "These dose-escalating phase I studies with different administration strategies reveal a pharmacokinetic profile of EA-230 with a large volume of distribution and a short half-life. Furthermore, EA-230 was well tolerated and no safety issues emerged. These results have enabled further clinical development in a phase IIa trial assessing the pharmacodynamics of this compound during systemic inflammation described elsewhere in this issue."

Clinical • Journal • PK/PD data • Immune Modulation • Immunology • Inflammation

The Human Chorionic Gonadotropin Derivate EA-230 Modulates the Immune Response and Exerts Renal Protective Properties: Therapeutic Potential in Humans. (PubMed, Semin Nephrol) - "In this review, we describe the immunomodulatory and renoprotective properties of EA-230 in preclinical animal models, phase 1 studies in humans and phase 2a studies performed during human experimental endotoxemia. In addition, details pertaining to the design of a recently completed phase 2b study in 180 patients who underwent cardiac surgery to investigate the safety and immunomodulatory and renoprotective properties of EA-230 are discussed."

Journal • Review • Cardiovascular • Immune Modulation • Immunology • Inflammation • Renal Disease • Systemic Inflammatory Response Syndrome

PK/PD of EA-230 During Endotoxemia (clinicaltrials.gov) - P1; N=60; Completed; Sponsor: Radboud University; Active, not recruiting ➔ Completed

Trial completion • Biosimilar • Immunology

Renal Effects of the Beta-HCG Derivative EA-230 in Cardiac Surgery Patients (AKI-CRRT 2020) - No abstract available

Clinical • Late-breaking abstract

Immunomodulatory and Kidney-Protective Effects of the Human Chorionic Gonadotropin Derivate EA-230. (PubMed, Nephron) - "Furthermore, an excellent safety profile of EA-230 was observed in phase 1 studies in humans, and the immunomodulatory effects of EA-230 were recently demonstrated in a phase IIa study during human experimental endotoxemia. A prospective double-blind placebo-controlled randomized trial in 180 patients undergoing elective CABG-surgery with or without valve surgery is currently conducted to investigate the immunomodulatory and renoprotective properties of EA-230."

Journal

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. (PubMed, JMIR Res Protoc) - P2; "This adaptive phase 2 clinical study is designed to test the safety and tolerability of EA-230 in patients undergoing cardiac surgery. In addition, efficacy end points focused on the effect of the systemic inflammatory response and renal function are investigated."

Clinical • Journal • P2 data