Randomized Double Blind Placebo-controlled Phase II Study on the Effects of EA-230 on the Systemic Inflammatory Response Following On-pump Cardiac Surgery

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.

Start Date01 Jun 2016

Sponsor / Collaborator

Radboud University Medical Center

[+1]

NCT02629874 / CompletedPhase 1IIT

Randomized Double Blind Placebo-controlled Clinical Safety, Tolerability and Pharmacokinetic/-Dynamic Study on the Effects of Escalating Single Intravenous Doses of EA-230 on the Innate Immune Response During Experimental Human Endotoxemia

EA-230 is a newly developed synthetic compound with anti-inflammatory properties. Pre-clinical data indicate that EA-230 may be a valuable treatment for systemic inflammation resulting from a variety of causes such as surgery, trauma, infection, irradiation and others. Although previous studies in healthy volunteers have shown an excellent safety profile, the safety and tolerability of higher doses administered per continuous infusion need to be investigated. Also, the dose-effect relation on systemic inflammation needs to be further elucidated before a phase II trial in patients can be commenced.

Start Date01 Feb 2015

Sponsor / Collaborator

Radboud University Medical Center

[+1]

EUCTR2014-002481-78-NL / Not yet recruitingPhase 1/2

Randomized double blind placebo-controlled clinical safety, tolerability and pharmacokinetic/-dynamic study on the effects of escalating single intravenous doses of EA-230 on the innate immune response during experimental human endotoxemia - PK/PD of EA-230 during endotoxemia

Start Date07 Oct 2014

Sponsor / Collaborator

Exponential Biotherapies, Inc.

100 Clinical Results associated with EA-230

100 Translational Medicine associated with EA-230

100 Patents (Medical) associated with EA-230

Literatures (Medical) associated with EA-230

01 May 2021·Critical Care MedicineQ1 · MEDICINE

Safety and Efficacy of Human Chorionic Gonadotropin Hormone-Derivative EA-230 in Cardiac Surgery Patients: A Randomized Double-Blind Placebo-Controlled Study

Q1 · MEDICINE

Article

Author: Wensvoort, Gert ; Pickkers, Peter ; van der Hoeven, Johannes G ; Hofland, Jan ; van Eijk, Lucas T ; Kooistra, Emma J ; Hemelaar, Pleun ; Gerretsen, Jelle ; Kox, Matthijs ; Waanders, Denise ; Claassen, Wout J ; van Groenendael, Roger ; Buijsse, Leonie S E ; Lamberts, Maud G A ; Beunders, Remi ; Morshuis, Wim J

OBJECTIVES:To determine the safety and efficacy of human chorionic gonadotropin hormone-derivative EA-230 in cardiac surgery patients. Cardiac surgery induces systemic inflammation and may impair renal function, affecting patient outcome. EA-230 exerted immunomodulatory and renoprotective effects in preclinical models and was safe and showed efficacy in phase I and II human studies.DESIGN:Double-blinded, placebo-controlled, randomized study.SETTING:Collaboration of the Cardiothoracic Surgery, Anesthesiology, and the Intensive Care departments of a tertiary hospital in the Netherlands.PATIENTS:One hundred eighty patients undergoing an on-pump coronary artery bypass procedure with or without concomitant valve surgery.INTERVENTIONS:Ninety mg/kg/hr EA-230 or placebo administered during surgery.MEASUREMENTS AND MAIN RESULTS:During the study, no safety concerns emerged. EA-230 did not modulate interleukin-6 plasma concentrations (area under the curve 2,730 pg/mL × hr [1,968–3,760] vs 2,680 pg/mL × hr [2,090–3,570] for EA-230 and placebo group, respectively; p = 0.80). Glomerular filtration rate increased following surgery (mean ± sem increase in the EA-230 vs placebo groups: glomerular filtration rateiohexol measured using iohexol plasma clearance: 19 ± 2 vs 16 ± 2 mL/min/1.73 m2; p = 0.13 and estimated glomerular filtration rate with the Modification of Diet in Renal Disease equation using creatinine: 6 ± 1 vs 2 ± 1 mL/min/1.73 m2; p = 0.01). The “injury” stage of the Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease criteria for acute kidney injury was 7% in the EA-230 group versus 18% in the placebo group (p = 0.07). In addition, EA-230-treated patients had a less positive fluid balance compared with placebo-treated patients (217 ± 108 vs 605 ± 103 mL; p = 0.01), while the use of vasoactive agents was similar in both groups (p = 0.39). Finally, hospital length of stay was shorter in EA-230 treated patients (8 d [7–11] vs 10 d [8–12]; p = 0.001). Efficacy results were more pronounced in patients that had longer duration of surgery and thus longer duration of study drug infusion.CONCLUSIONS: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.

01 Sep 2019·Seminars in NephrologyQ2 · MEDICINE

The Human Chorionic Gonadotropin Derivate EA-230 Modulates the Immune Response and Exerts Renal Protective Properties: Therapeutic Potential in Humans

Q2 · MEDICINE

Review

Author: van Eijk, Lucas T ; van Groenendael, Roger ; Pickkers, Peter ; Kox, Matthijs ; Beunders, Remi

The extent of the systemic inflammatory response following infectious or noninfectious insults is related to impaired patient outcome. Pregnancy is associated with immunotolerance and an increased glomerular filtration rate. EA-230 is a newly developed synthetic linear tetrapeptide derived from the "pregnancy hormone" human chorionic gonadotropin. 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.

01 Jul 2019·British Journal of Clinical PharmacologyQ2 · MEDICINE

A randomized double‐blind, placebo‐controlled clinical phase IIa trial on safety, immunomodulatory effects and pharmacokinetics of EA‐230 during experimental human endotoxaemia

Q2 · MEDICINE

Article

Author: Pickkers, Peter ; Koeneman, Bouke ; van Eijk, Lucas ; Leijte, Guus ; Kox, Matthijs ; van Groenendael, Roger ; Gerretsen, Jelle

AimsEA‐230 is a human chorionic gonadotropin hormone‐derived linear tetrapeptide, developed for the treatment of systemic inflammation‐related disorders. EA‐230 has shown promising immunomodulatory and tissue‐protective effects in animals and an excellent safety profile in human phase I studies that we performed. The present phase IIa study follows‐up on these results by investigating the safety, efficacy and pharmacokinetics of EA‐230 under systemic inflammatory conditions induced by experimental human endotoxaemia.MethodsIn this randomized, double blind, placebo‐controlled phase IIa study, systemic inflammation was induced by intravenous administration of Escherichia coli‐derived lipopolysaccharide (LPS). At t = 0 hours, 36 healthy male volunteers received 2 ng/kg LPS, followed by a 2‐hour continuous infusion of EA‐230 (15, 45 and 90 mg/kg/h, n = 8 per group) or placebo (n = 12).ResultsEA‐230 was well tolerated and showed a favourable safety profile. Treatment with the highest dose of EA‐230 resulted in a significant attenuation of the LPS‐induced increase in plasma levels of inflammatory mediators interleukin (IL)‐6, IL‐8, IL‐1 receptor antagonist, monocyte chemoattractant protein‐1, macrophage inflammatory proteins‐1α and ‐1β, and vascular cell adhesion protein‐1 (% reduction of 48, 28, 33, 28, 14, 16 and 19 respectively, p < .01), and reduced fever (peak decrease from 1.8 ± 0.1°C to 1.3 ± 0.2°C, P < .05) and symptom scores (peak decrease from 7.4 ± 1.0 to 4.0 ± 1.2 points, P < .05). EA‐230 exhibited a very short elimination half‐life and a large volume of distribution in the highest dosage group (geometric mean and 95% confidence interval: 0.17 [0.12–0.24] hours and 2.2 [1.3–3.8] L/kg, respectively).ConclusionAdministration of EA‐230 is safe and results in attenuation of the systemic inflammatory response in humans.

News (Medical) associated with EA-230

21 Jun 2022

·www.prnewswire.com

Acute Kidney Injury Market to Grow at a CAGR of Approximately 8% by 2032 | DelveInsight

The dynamics of acute kidney injury market is anticipated to change in the coming years owing to the improvement in the diagnosis methodologies, raising awareness of the disease, incremental healthcare spending across the world and the expected launch of the emerging therapies during the forecast period. LAS VEGAS, June 21, 2022 /PRNewswire/ -- DelveInsight's Acute Kidney Injury Market Insights report includes a comprehensive understanding of current treatment practices, Acute Kidney Injury emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM (the United States, the EU5 (the United Kingdom, Italy, Spain, France, and Germany), and Japan. Key Takeaways from the Acute Kidney Injury Market Report As per DelveInsight analysis, the Acute Kidney Injury market size in the 7MM was approximately USD 5.4 billion in 2020. As per DelveInsight analysis, the total Acute Kidney Injury incident cases in the 7MM were approximately 10.9 million in 2020. The United States contributed to the largest incident-patient share (mortality adjusted), acquiring ~ 34.09% of the 7MM in 2020 Rising incidence of AKI will provide a larger window of opportunity for new treatment and prevention options The pipeline of AKI is quite robust with diverse products strengthening targeting prophylaxis of AKI in several complications such as Sepsis and post-cardiac-surgery mainlyLeading acute kidney injury companies such as Cerenis Therapeutics, Alloksys, Vifor Pharma, Exponential Biotherapies, Atox Bio, AM Pharma Holding, Quark-Pharmaceuticals, Nephraegis Therapeutics, Vasomune, Unicycive, LG Chem, Pharming Group, Angion Biomedica, Elysium Health, Sentien Biotechnologies, Pharmazz, Arch Biopartners, Guard Therapeutics, RegeneRx Biopharmaceuticals, Astellas Pharma, Amniotics, Mission Therapeutics, Bessor pharma, Kantum Pharma, ABIONYX, and others are developing novel drug candidates to improve the Acute Kidney Injury treatment landscape. The Acute Kidney Injury therapies in the pipeline include bRESCAP, ANG-3777, EA-230, Ilofotase alfa, ASP1128, Ruconest (Conestat alfa) , and others. The key driver for the surge in acute kidney injury market size is the rise in the number of incident cases of acute kidney injury. Discover more about therapies set to grab major acute kidney injury market share @ Acute Kidney Injury Market Landscape Acute Kidney Injury Overview Acute kidney injury (AKI), also known as acute renal failure (ARF), is a disorder that causes progressive azotemia with or without oliguria over a period of hours or days. Acute kidney injury is defined as a sudden loss of renal function, clinically expressed as an acute reversible surge in nitrogen waste products as measured by blood urea nitrogen and serum creatinine levels over hours to weeks. Acute kidney injury causes an abrupt loss in renal function, which results in waste product retention, electrolyte abnormalities, and changes in volume status. Acute kidney injury is classified into prerenal, postrenal, and intrinsic renal. Many people with acute kidney injury are asymptomatic, while others experience generalized non-specific acute kidney injury symptoms such as nausea, vomiting, weakness, dizziness, lower back pain, passing less urine than usual, unexplained loss of appetite, feeling sick or vomiting, shortness of breath, and swelling of the legs or other body parts. An increase in serum creatinine and a reduction in urine output are commonly used for acute kidney injury diagnosis. Acute Kidney Injury Epidemiology Segmentation As per DelveInsight, there were approx 10.9 million acute kidney injury incident cases in the 7MM in 2020. Among the EU5 countries, Germany had the highest acute kidney injury incident population in 2020. The Acute Kidney Injury market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into Total Incident Population of Acute Kidney Injury (AKI) in Hospitalized Patients Mortality Adjusted Incident Population of AKI in Hospitalized Patients Stage-specific Incident Population of AKI Age-specific Incident Population of AKI Download the report to understand which factors are driving acute kidney injury epidemiology trends @ Acute Kidney Injury Epidemiological Insights Acute Kidney Injury Treatment Market For the past several years; it has been observed that the current acute kidney injury treatment is primarily supportive in character, with no therapeutic approaches demonstrating benefit in treating the condition. Off-label acute kidney injury medications used to treat AKI include ACE inhibitors, angiotensin II-receptor blockers (ARBs), diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), and renal replacement therapy (RRT). Monitoring urine output and, at first, serum creatinine levels (SCr) numerous times each day is a cornerstone of the therapy for all patients with acute kidney injury. It is also indicated to correct electrolyte imbalances, quit or adjust nephrotoxic medicines, and dose-adjust pharmaceuticals with renal elimination. To know more about Acute Kidney Injury treatment, visit @ Acute Kidney Injury Guidelines Acute Kidney Injury Pipeline Therapies and Key Companies bRESCAP: Alloksys ANG-3777 (BB3): Angion Biomedica/ Vifor Pharma EA-230: Exponential Biotherapies Ilofotase alfa: AM Pharma ASP1128: Astellas Pharma Ruconest (Conestat alfa): Pharming Technologies Learn more about the acute kidney injury medications @ Drugs for Acute Kidney Injury Acute Kidney Injury Market Dynamics Treatment-related adverse effects are quite rare, resulting in successful acute kidney injury treatment choices. Moreover, patients have easy access to reimbursements since their ailment necessitates long-term management, such as dialysis. In addition, several government activities are being undertaken by adopting various programs concerning acute kidney injury, which is expected to improve the global AKI prospect and thus bolster the actue kidney injury market. Furthermore, several biomarkers, including NGAL, Cystatin-C, and others, are being investigated for use in acute kidney injury diagnosis. The validation of these new biomarkers could provide new methods for detecting the start and severity of kidney injury. Future research in the acute kidney injury market is underway with the goal of better understanding of the underlying processes and, as a result, improve outcomes for AKI patients. Moreover, a robust pipeline with a novel mechanism of action and increasing incidence are major market drivers of the acute kidney injury market. Additionally, the acute kidney injury pipeline is also expected to change the current dynamics of the acute kidney injury market, which presently comprises biologics and molecules with new mechanisms of action like ANG-3777 (BB3), ASP1128, Ilofotase alfa, Ruconest (Conestat alfa), bRESCAP, EA230, and others. However, there are several barriers to the acute kidney injury market growth. One such factor is the lack of awareness. If the patients have cardiac issues, the situation becomes even more complex. Moreover, long-term health repercussions, as well as longer hospital stays and high health-care expenses, highlight AKI's enormous societal impact. In addition, several risk factors, such as diabetes and heart failure, have substantial implications for patients' quality of life, making it challenging to develop promising future interventions and thus hindering the acute kidney injury market growth. Scope of the Acute Kidney Injury Market Report Study Period: 2019–2032 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key Acute Kidney Injury Companies: Cerenis Therapeutics Alloksys, Vifor Pharma, Exponential Biotherapies, Atox Bio, AM Pharma Holding, Quark-Pharmaceuticals, Nephraegis Therapeutics, Vasomune, Unicycive, LG Chem, Pharming Group, Angion Biomedica, Elysium Health, Sentien Biotechnologies, Pharmazz, Arch Biopartners, Guard Therapeutics, RegeneRx Biopharmaceuticals, Astellas Pharma, Amniotics, Mission Therapeutics, Bessor pharma, Kantum Pharma, ABIONYX, and others Key Acute Kidney Injury Therapies: bRESCAP, ANG-3777, EA-230, Ilofotase alfa, ASP1128, Ruconest (Conestat alfa), and others Therapeutic Assessment: Acute kidney injury current marketed and emerging therapies Acute Kidney Injury Market Dynamics: Acute kidney injury market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, Acute Kidney Injury Market Access and Reimbursement Discover more about acute kidney injury drugs in development @ Acute Kidney Injury Clinical Trials Table of Contents Get in touch with our Business executive @ Healthcare Due Diligence Services Related Reports Acute Kidney Injury Pipeline Acute Kidney Injury Pipeline Insight, 2022 report provides comprehensive insights about pipeline drug profiles, including clinical and non-clinical stage products. It also covers the key acute kidney injury companies including Atox Bio, AM Pharma Holding, Quark-Pharmaceuticals, LG Chem, Pharming Group, Angion Biomedica, among others. Acute Kidney Injury Epidemiology Forecast Acute Kidney Injury Epidemiology Forecast to 2032 report delivers an in-depth understanding of the disease, historical and forecasted acute kidney injury epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Chronic Kidney Disease Pipeline Chronic Kidney Disease Pipeline Insight, 2022 report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in the pipeline landscape. It covers the pipeline drug profiles, including clinical and non-clinical stage products. It also covers the key chronic kidney disease companies, including Bayer, AstraZeneca, Celgene, Ipsen, among others. Anemia in Chronic Kidney Disease Pipeline Anemia in Chronic Kidney Disease Pipeline Insight, 2022 report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in the pipeline landscape. It covers the pipeline drug profiles, including clinical and non-clinical stage products. It also covers the key anemia in chronic kidney disease companies, including Pieris Pharmaceuticals, Jiangsu HengRui Medicine, Shenyang Sunshine Pharmaceutical, Biocad, among others. Diabetic Kidney Disease Pipeline Diabetic Kidney Disease Pipeline Insight, 2022 report provides comprehensive insights about pipeline drug profiles, including clinical and non-clinical stage products. It also covers the key diabetic kidney disease companies, including Gilead Sciences, Kyowa Kirin, Bayer, among others. Polycystic Kidney Disease Pipeline Polycystic Kidney Disease Pipeline Insight, 2022 report provides comprehensive insights about 22+ companies and 22+ pipeline drugs in the pipeline landscape. It covers the pipeline drug profiles, including clinical and non-clinical stage products. It also covers the key anemia in polycystic kidney disease companies, including Abbott, Reata Pharmaceuticals, XORTX Therapeutics, Sanofi Genzyme, among others. Kidney Transplant Rejection Pipeline Kidney Transplant Rejection Pipeline Insight, 2022 report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in the pipeline landscape. It covers the pipeline drug profiles, including clinical and non-clinical stage products. It also covers the key anemia in kidney transplant rejection companies, including Medeor Therapeutics, Talaris Therapeutics, CSL Behring, Novartis, among others. Other Trending Reports Pediatric Growth Hormone Deficiency Market | Non-Cystic Fibrosis Bronchiectasis Market | X-Linked Retinitis Pigmentosa Market | Otitis Media Market | Central Retinal Vein Occlusion Market | Frontotemporal Dementia Market | Follicular Lymphoma Market | Diabetes Market | Blastic Plasmacytoid Dendritic Cell Neoplasm Market | Bevacizumab Biosimilars Insight | Bacterial Conjunctivitis Market | FENEBRUTINIB Market | Peripherally Inserted Central Catheter Devices Market | Cardiac Biomarkers Testing Devices Market Related Healthcare Blogs Acute Kidney Injury Market Outlook Acute Kidney Injury Treatment Market IgA Nephropathy Market About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

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Indication	Highest Phase	Country/Location	Organization	Date
Systemic Inflammatory Response Syndrome	Phase 3	NL	Exponential Biotherapies, Inc.	01 Jun 2016
Endotoxemia	Phase 3	NL	Exponential Biotherapies, Inc.	01 Feb 2015
Acute Kidney Injury	Phase 1	NL	Exponential Biotherapies, Inc.	30 Jan 2022
Radiation Injuries	Preclinical	NL	Exponential Biotherapies, Inc.	30 Jan 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02629874 (Pubmed \| Br J Clin Pharmacol) Manual	Phase 2	Endotoxemia	36	EA-230	(zzstngrlby) = bsgevxajpd dwhsexkthv (lytmyixomd, 1.3 - 3.8) View more	Positive	01 Jul 2019
				Placebo	-

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